{"id":995853,"date":"2026-08-17T07:33:57","date_gmt":"2026-08-17T11:33:57","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/enhertu-fam-trastuzumab-deruxtecan-nxki-demonstrated-statistically-significant-and-clinically-meaningful-improvement-in-pfs-as-1st-line-treatment-of-patients-with-her2-mutant-advanced-non-smal\/"},"modified":"2026-08-17T07:33:57","modified_gmt":"2026-08-17T11:33:57","slug":"enhertu-fam-trastuzumab-deruxtecan-nxki-demonstrated-statistically-significant-and-clinically-meaningful-improvement-in-pfs-as-1st-line-treatment-of-patients-with-her2-mutant-advanced-non-smal","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/enhertu-fam-trastuzumab-deruxtecan-nxki-demonstrated-statistically-significant-and-clinically-meaningful-improvement-in-pfs-as-1st-line-treatment-of-patients-with-her2-mutant-advanced-non-smal\/","title":{"rendered":"ENHERTU\u00ae (fam-trastuzumab deruxtecan-nxki) demonstrated statistically significant and clinically meaningful improvement in PFS as 1st-line treatment of patients with HER2-mutant advanced non-small cell lung cancer in DESTINY-Lung04 Phase III trial"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }\n.bwblockalignl { margin-left: 0px; margin-right: auto }\n.bwcellpmargin { margin-bottom: 0px; margin-top: 0px }\n.bwleftsingle { border-left: solid black 1pt }\n.bwlistdecimal { list-style-type: decimal }\n.bwlistdisc { list-style-type: disc }\n.bwpadl0 { padding-left: 0px }\n.bwrightsingle { border-right: solid black 1pt }\n.bwsinglebottom { border-bottom: solid black 1pt }\n.bwtablemarginb { margin-bottom: 10px }\n.bwtopsingle { border-top: solid black 1pt }\n.bwuline { text-decoration: underline }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>ENHERTU<sup>\u00ae<\/sup> (fam-trastuzumab deruxtecan-nxki) demonstrated statistically significant and clinically meaningful improvement in PFS as 1st-line treatment of patients with HER2-mutant advanced non-small cell lung cancer in DESTINY-Lung04 Phase III trial<\/b><\/p>\n<p class=\"bwalignc\"><i><b>AstraZeneca and Daiichi Sankyo\u2019s ENHERTU is the first and only <\/b><\/i><i><b>HER2-directed medicine to improve progression-free survival <\/b><\/i><i><b>over global standard of care in a Phase III trial in this setting<\/b><\/i><\/p>\n<p>WILMINGTON, Del.&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nPositive high-level results from the DESTINY-Lung04 Phase III trial showed ENHERTU<sup>\u00ae<\/sup> (fam-trastuzumab deruxtecan-nxki) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus global standard of care (platinum-pemetrexed doublet chemotherapy plus pembrolizumab) as 1st-line treatment of patients with unresectable, locally advanced or metastatic <i>HER2<\/i>-mutant non-squamous non-small cell lung cancer (NSCLC). The trial will continue as planned to evaluate secondary endpoints including overall survival.<\/p>\n<p>\nThe global standard of care for patients with <i>HER2-<\/i>mutant NSCLC in the 1st-line metastatic setting is a combination of immunotherapy and platinum-based chemotherapy.<sup>1-3<\/sup> However, many patients do not respond to 1st-line treatment and experience disease progression, underscoring the need for additional treatment options.<sup>3-7<\/sup> Approximately 2-4% of patients with NSCLC have tumors with a <i>HER2 <\/i>mutation.<sup>8-10<\/sup><\/p>\n<p>\nSusan Galbraith, Executive Vice President, Oncology Haematology R&amp;D, AstraZeneca, said: \u201cOur oncology pipeline continues to advance with DESTINY-Lung04 becoming the first Phase III trial to demonstrate a progression-free survival benefit versus the global standard of care in this 1st-line setting, supporting the potential for<i \/>ENHERTU to move earlier in the treatment of <i>HER2<\/i>-mutant non-small cell lung cancer. This aggressive lung cancer often affects younger patients and has historically had limited 1st-line targeted treatment options, making these positive results an important step forward in bringing additional effective therapies to patients at metastatic diagnosis when there is the greatest opportunity to improve outcomes.\u201d<\/p>\n<p>\nJohn Tsai, Global Head, R&amp;D, Daiichi Sankyo, said: \u201cENHERTU is already established as the first and only antibody drug conjugate for the 2nd-line treatment of <i>HER2<\/i>-mutant metastatic non-small cell lung cancer. The positive results seen in DESTINY-Lung04 show that treatment with ENHERTU in the 1st-line setting delays disease progression compared to the global standard of care, highlighting its potential to improve outcomes for patients earlier in the treatment of metastatic disease.\u201d<\/p>\n<p>\nThe safety profile of ENHERTU<i \/>observed in DESTINY-Lung04 was generally consistent with its known profile, with no new safety concerns identified.<\/p>\n<p>\nThe DESTINY-Lung04 data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.<\/p>\n<p>\nENHERTU is currently approved to treat patients with previously treated metastatic NSCLC whose tumors have activating <i>HER2 <\/i>(<i>ERBB2<\/i>) mutations, and to treat patients with HER2-positive solid tumors, including HER2-overexpressing metastatic NSCLC, who have received prior treatment and who have no satisfactory treatment options.<\/p>\n<p>\nENHERTU is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.<\/p>\n<p><b>Enhertu U.S. Indications and Important Safety Information<\/b><\/p>\n<p><b>Indications<br \/>\n<br \/><\/b>ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for:<\/p>\n<ul class=\"bwlistdisc\">\n<li><span class=\"bwuline\">HER2-Positive Early Breast Cancer<br \/>\n<br \/><\/span>&#8211; As neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test followed by a taxane, trastuzumab, and pertuzumab (THP)<br \/>\n<br \/>&#8211; As adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment<\/p>\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li><span class=\"bwuline\">HER2-Positive Metastatic Breast Cancer<br \/>\n<br \/><\/span>&#8211; In combination with pertuzumab as first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-authorized test<br \/>\n<br \/>&#8211; As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or, in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy<\/p>\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li><span class=\"bwuline\">HER2-Low and HER2-Ultralow Metastatic Breast Cancer<br \/>\n<br \/><\/span>&#8211; As monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+\/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-authorized test, that has progressed on one or more endocrine therapies in the metastatic setting<br \/>\n<br \/>&#8211; As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+\/ISH-) breast cancer, as determined by an FDA-authorized test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy<\/p>\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li><span class=\"bwuline\">HER2-Mutant Unresectable or Metastatic Non-Small Cell Lung Cancer (NSCLC)<br \/>\n<br \/><\/span>&#8211; As monotherapy for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-authorized test, and who have received a prior systemic therapy<\/p>\n<p>This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.<\/p>\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li><span class=\"bwuline\">HER2-Positive Locally Advanced or Metastatic Gastric Cancer<br \/>\n<br \/><\/span>&#8211; As monotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+\/ISH positive) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen<\/p>\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li><span class=\"bwuline\">HER2-Positive (IHC 3+) Unresectable or Metastatic Solid Tumors<br \/>\n<br \/><\/span>&#8211; As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options<\/p>\n<p>This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.<\/p>\n<\/li>\n<\/ul>\n<p><b>Important Safety Information<\/b><\/p>\n<table cellspacing=\"0\" class=\"bwtablemarginb bwblockalignl\">\n<tr>\n<td class=\"bwpadl0 bwtopsingle bwleftsingle bwrightsingle bwsinglebottom\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin\"><b>WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY<\/b><\/p>\n<ul class=\"bwlistdisc\">\n<li><b>Interstitial lung disease (ILD) and pneumonitis, including severe, life-threatening, and fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD\/pneumonitis. Advise patients of the risk and to immediately report symptoms.<\/b><\/li>\n<li><b>Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception.<\/b><\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<\/table>\n<p><b>Contraindications<br \/>\n<br \/><\/b>None.<\/p>\n<p><b>Warnings and Precautions<br \/>\n<br \/><\/b><b>Interstitial Lung Disease \/ Pneumonitis<br \/>\n<br \/><\/b>Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU. A higher incidence of Grade 1 and 2 ILD\/pneumonitis has been observed in patients with moderate renal impairment. Advise patients to immediately report cough, dyspnea, fever, and\/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD. Promptly investigate evidence of ILD. Evaluate patients with suspected ILD by radiographic imaging. Consider consultation with a pulmonologist. For asymptomatic ILD\/pneumonitis (Grade 1), interrupt ENHERTU until resolved to Grade 0, then if resolved in \u226428 days from date of onset, maintain dose. If resolved in &gt;28 days from date of onset, reduce dose 1 level. Consider corticosteroid treatment as soon as ILD\/pneumonitis is suspected (e.g., \u22650.5 mg\/kg\/day prednisolone or equivalent). For symptomatic ILD\/pneumonitis (Grade 2 or greater), permanently discontinue ENHERTU. Promptly initiate systemic corticosteroid treatment as soon as ILD\/pneumonitis is suspected (e.g., \u22651 mg\/kg\/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks. In the adjuvant HER2+ breast cancer setting, if drug-induced ILD is suspected, rule out radiotherapy-related pneumonitis. If only radiotherapy-related pneumonitis is suspected, consider interruption of ENHERTU for Grade 2 and permanently discontinue ENHERTU for Grade \u22653.<\/p>\n<p><span class=\"bwuline\">HER2-Positive, HER2-Low, and HER2-Ultralow Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg\/kg)<br \/>\n<br \/><\/span><i>ENHERTU as Monotherapy<br \/>\n<br \/><\/i>In patients treated with ENHERTU 5.4 mg\/kg, ILD occurred in 12% of patients. Median time to first onset was 5.5 months (range: 0.9 to 31.5). Fatal outcomes due to ILD and\/or pneumonitis occurred in 0.9% of patients treated with ENHERTU.<\/p>\n<p><i>ENHERTU in Combination with Pertuzumab<br \/>\n<br \/><\/i>In patients treated with ENHERTU 5.4 mg\/kg in combination with pertuzumab (N=431), ILD occurred in 12% of patients. Median time to first onset was 8.0 months (range: 0.6 to 33.8). Fatal outcomes due to ILD and\/or pneumonitis occurred in 0.5% of patients treated with ENHERTU in combination with pertuzumab.<\/p>\n<p><i>ENHERTU followed by THP<br \/>\n<br \/><\/i>In patients treated with ENHERTU 5.4 mg\/kg followed by THP in DESTINY-Breast11, ILD occurred in 4.4% of patients. Median time to first onset was 2.7 months (range: 1.1 to 6.0). Fatal outcomes due to ILD and\/or pneumonitis occurred in 1 patient (0.3%) treated with ENHERTU followed by THP.<\/p>\n<p><span class=\"bwuline\">HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg\/kg)<br \/>\n<br \/><\/span>In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg\/kg, ILD occurred in 10% of patients. Median time to first onset was 2.8 months (range: 1.2 to 21).<\/p>\n<p><b>Neutropenia<br \/>\n<br \/><\/b>Severe neutropenia, including febrile neutropenia, can occur in patients treated with ENHERTU. Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC] &lt;1.0 to 0.5 x 10<sup>9<\/sup>\/L), interrupt ENHERTU until resolved to Grade 2 or less, then maintain dose. For Grade 4 neutropenia (ANC &lt;0.5 x 10<sup>9<\/sup>\/L), interrupt ENHERTU until resolved to Grade 2 or less, then reduce dose by 1 level. For febrile neutropenia (ANC &lt;1.0 x 10<sup>9<\/sup>\/L and temperature &gt;38.3\u00ba C or a sustained temperature of \u226538\u00ba C for more than 1 hour), interrupt ENHERTU until resolved, then reduce dose by 1 level.<\/p>\n<p><span class=\"bwuline\">HER2-Positive, HER2-Low, and HER2-Ultralow Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg\/kg)<br \/>\n<br \/><\/span><i>ENHERTU as Monotherapy<br \/>\n<br \/><\/i>In patients treated with ENHERTU 5.4 mg\/kg, a decrease in neutrophil count was reported in 65% of patients. Nineteen percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 22 days (range: 2 to 939). Febrile neutropenia was reported in 1% of patients.<\/p>\n<p><i>ENHERTU in Combination with Pertuzumab<br \/>\n<br \/><\/i>In patients treated with ENHERTU 5.4 mg\/kg in combination with pertuzumab (N=431), decreased neutrophil count occurred in 79% of patients. Median time to first onset was 22 days (range: 5 to 994). Twenty-nine percent had Grade 3 or 4 decreased neutrophil count. Febrile neutropenia was reported in 2.6% of patients.<\/p>\n<p><i>ENHERTU followed by THP<br \/>\n<br \/><\/i>In patients treated with ENHERTU 5.4 mg\/kg followed by THP in DESTINY-Breast11, a decrease in neutrophil count was reported in 58% of patients. Seventeen percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 42 days (range: 11 to 165). Febrile neutropenia was reported in 0.9% of patients.<\/p>\n<p><span class=\"bwuline\">HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg\/kg)<br \/>\n<br \/><\/span>In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg\/kg, a decrease in neutrophil count was reported in 72% of patients. Fifty-one percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 16 days (range: 4 to 187). Febrile neutropenia was reported in 4.8% of patients.<\/p>\n<p><b>Left Ventricular Dysfunction<br \/>\n<br \/><\/b>Patients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. Left ventricular dysfunction (LVD) has been observed with anti-HER2 therapies, including ENHERTU. Assess left ventricular ejection fraction (LVEF) prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. Manage LVD through treatment interruption. When LVEF is &gt;45% and absolute decrease from baseline is 10-20%, continue treatment with ENHERTU. When LVEF is 40-45% and absolute decrease from baseline is &lt;10%, continue treatment with ENHERTU and repeat LVEF assessment within 3 weeks. When LVEF is 40-45% and absolute decrease from baseline is 10-20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF has not recovered to within 10% from baseline, permanently discontinue ENHERTU. If LVEF recovers to within 10% from baseline, resume treatment with ENHERTU at the same dose. When LVEF is &lt;40% or absolute decrease from baseline is &gt;20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF of &lt;40% or absolute decrease from baseline of &gt;20% is confirmed, permanently discontinue ENHERTU. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure. Treatment with ENHERTU has not been studied in patients with a history of clinically significant cardiac disease or LVEF &lt;50% prior to initiation of treatment.<\/p>\n<p><span class=\"bwuline\">HER2-Positive, HER2-Low, and HER2-Ultralow Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg\/kg)<br \/>\n<br \/><\/span><i>ENHERTU as Monotherapy<br \/>\n<br \/><\/i>In patients treated with ENHERTU 5.4 mg\/kg, LVD was reported in 4.6% of patients, of which 0.6% were Grade 3 or 4.<\/p>\n<p><i>ENHERTU in Combination with Pertuzumab<br \/>\n<br \/><\/i>In patients treated with ENHERTU 5.4 mg\/kg in combination with pertuzumab (N=431), LVEF decrease was reported in 11% of patients, of which 2.1% were Grade 3 or 4.<\/p>\n<p><i>ENHERTU followed by THP<br \/>\n<br \/><\/i>In patients treated with ENHERTU 5.4 mg\/kg followed by THP in DESTINY-Breast11, LVD was reported in 1.3% of patients, of which 0.3% were Grade 3.<\/p>\n<p><span class=\"bwuline\">HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg\/kg)<br \/>\n<br \/><\/span>In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg\/kg, no clinical adverse events of heart failure were reported; however, on echocardiography, 8% were found to have asymptomatic Grade 2 decrease in LVEF.<\/p>\n<p><b>Embryo-Fetal Toxicity<br \/>\n<br \/><\/b>ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of ENHERTU. Advise females of reproductive potential to use effective contraception during treatment and for 7 months after the last dose of ENHERTU. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for 4 months after the last dose of ENHERTU.<\/p>\n<p><b>Additional Dose Modifications<br \/>\n<br \/><\/b><b>Thrombocytopenia<br \/>\n<br \/><\/b>For Grade 3 thrombocytopenia (platelets &lt;50 to 25 x 10<sup>9<\/sup>\/L) interrupt ENHERTU until resolved to Grade 1 or less, then maintain dose. For Grade 4 thrombocytopenia (platelets &lt;25 x 10<sup>9<\/sup>\/L) interrupt ENHERTU until resolved to Grade 1 or less, then reduce dose by 1 level.<\/p>\n<p><b>Adverse Reactions<br \/>\n<br \/><\/b><span class=\"bwuline\">HER2-Positive, HER2-Low, and HER2-Ultralow Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg\/kg)<br \/>\n<br \/><\/span><i>ENHERTU as Monotherapy<br \/>\n<br \/><\/i>The pooled safety population reflects exposure to ENHERTU 5.4 mg\/kg intravenously every 3 weeks in 2233 patients in Study DS8201-A-J101 (NCT02564900), DESTINY-Breast01, DESTINY-Breast02, DESTINY-Breast03, DESTINY-Breast04, DESTINY-Breast06, DESTINY-Lung01, DESTINY-Lung02, DESTINY-CRC02, and DESTINY-PanTumor02. Among these patients, 67% were exposed for &gt;6 months and 39% were exposed for &gt;1 year. In this pooled safety population, the most common (\u226520%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (73%), nausea (72%), decreased hemoglobin (67%), decreased neutrophil count (65%), decreased lymphocyte count (60%), fatigue (55%), decreased platelet count (48%), increased aspartate aminotransferase (46%), increased alanine aminotransferase (43%), increased blood alkaline phosphatase (39%), vomiting (38%), alopecia (37%), constipation (32%), decreased blood potassium (32%), decreased appetite (31%), diarrhea (30%), and musculoskeletal pain (24%).<\/p>\n<p><i>ENHERTU in Combination with Pertuzumab<br \/>\n<br \/><\/i>The pooled safety population reflects exposure to ENHERTU 5.4 mg\/kg in combination with pertuzumab intravenously every 3 weeks in 431 patients in DESTINY-Breast07 (n=50), and DESTINY-Breast09 (n=381). Among these patients, 86% were exposed for &gt;6 months and 73% were exposed for &gt;1 year. In this pooled safety population, the most common (\u226520%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (86%), decreased hemoglobin (80%), decreased neutrophil count (79%), nausea (74%), increased alanine aminotransferase (65%), diarrhea (64%), increased aspartate aminotransferase (63%), decreased lymphocyte count (61%), decreased platelet count (55%), increased blood alkaline phosphatase (54%), decreased blood potassium (54%), fatigue (53%), alopecia (48%), vomiting (46%), upper respiratory tract infection (32%), constipation (31%), decreased appetite (31%), decreased weight (28%), musculoskeletal pain (23%), increased blood bilirubin (23%), and abdominal pain (22%).<\/p>\n<p><span class=\"bwuline\">HER2-Positive Early Breast Cancer<br \/>\n<br \/><\/span><i>DESTINY-Breast11<br \/>\n<br \/><\/i>The safety of ENHERTU followed by THP was evaluated in 320 patients with HER2-positive (IHC 3+ or ISH+) early breast cancer who received at least 1 dose of ENHERTU 5.4 mg\/kg followed by THP in DESTINY-Breast11. ENHERTU was administered by intravenous infusion once every three weeks for 4 cycles followed by THP for 4 cycles. The median duration of treatment was 5.6 months (range: 0.7 to 9.1) for patients who received ENHERTU followed by THP.<\/p>\n<p>\nSerious adverse reactions occurred in 11% of patients receiving ENHERTU followed by THP, including COVID-19 (0.9%) and ILD\/pneumonitis (0.6%). Fatal adverse reactions occurred in 0.6% of patients, including ILD\/pneumonitis and death not otherwise specified (1 patient each).<\/p>\n<p>\nIn patients treated with ENHERTU followed by THP, the permanent discontinuation of ENHERTU due to adverse reactions occurred in 1.3%, of which ILD\/pneumonitis accounted for 0.6%. Dose interruptions of ENHERTU due to adverse reactions occurred in 11% of patients. The most frequent adverse reactions (&gt;2%) associated with dose interruption were decreased neutrophil count and COVID-19. Dose reductions of ENHERTU occurred in 2.5% of patients treated with ENHERTU.<\/p>\n<p>\nThe most common (\u226520%) adverse reactions in patients treated with ENHERTU followed by THP, including laboratory abnormalities, were decreased hemoglobin (83%), increased alanine aminotransferase (79%), increased aspartate aminotransferase (74%), decreased white blood cell count (67%), nausea (65%), peripheral neuropathy (59%), diarrhea (59%), decreased neutrophil count (58%), alopecia (48%), fatigue (41%), decreased lymphocyte count (40%), rash (31%), musculoskeletal pain (30%), decreased blood potassium (29%), constipation (29%), vomiting (29%), stomatitis (23%), and decreased appetite (20%).<\/p>\n<p><i>DESTINY-Breast05<br \/>\n<br \/><\/i>The safety of ENHERTU was evaluated in 806 patients with HER2-positive breast cancer with residual invasive disease following neoadjuvant HER2-targeted therapy who then received at least one dose of ENHERTU 5.4 mg\/kg. ENHERTU was administered by intravenous infusion once every three weeks for 14 cycles. The median duration of treatment was 10 months (range: 0.7 to 16) for patients who received ENHERTU.<\/p>\n<p>\nSerious adverse reactions occurred in 17% of patients receiving ENHERTU. Serious adverse reactions in \u22651% of patients who received ENHERTU were ILD\/pneumonitis, radiation pneumonitis, pneumonia, and platelet count decreased. Fatal adverse reactions occurred in 0.4% of patients including ILD\/pneumonitis (2 patients) and respiratory tract infection (1 patient).<\/p>\n<p>\nPermanent discontinuation of ENHERTU due to an adverse reaction occurred in 18% of patients. The adverse reaction which resulted in permanent discontinuation of ENHERTU &gt;2% included ILD\/pneumonitis. Dose interruptions of ENHERTU due to an adverse reaction occurred in 50% of patients. Adverse reactions which required dosage interruptions in &gt;2% included radiation pneumonitis, neutrophil count decreased, COVID-19, white blood cell count decreased, ILD\/pneumonitis, platelet count decreased, upper respiratory tract infection, fatigue, cough, and pyrexia. Dose reductions of ENHERTU due to an adverse reaction occurred in 26% of patients. Adverse reactions which required dose reductions in &gt;2% of patients included nausea, fatigue, platelet count decreased, ILD\/pneumonitis, and neutrophil count decreased.<\/p>\n<p>\nThe most common (\u226520%) adverse reactions, including laboratory abnormalities, in patients receiving ENHERTU were decreased white blood cell count (80%), decreased lymphocyte count (72%), decreased neutrophil count (72%), nausea (71%), decreased hemoglobin (61%), increased aspartate aminotransferase (60%), fatigue (54%), increased alanine aminotransferase (53%), decreased platelet count (46%), increased blood alkaline phosphatase (39%), constipation (32%), vomiting (31%), decreased blood potassium (27%), diarrhea (23%), musculoskeletal pain (23%), and decreased appetite (20%).<\/p>\n<p>\nILD was reported in 17% of patients receiving ENHERTU, which included COVID-19 pneumonia, interstitial lung disease, lung opacity, organizing pneumonia, pneumocystis jirovecii pneumonia, pneumonia, and pneumonitis which was adjudicated as ILD (irrespective of causality). Adjudicated drug-related ILD for ENHERTU was 10% for all Grades and 0.9% for Grades 3 or 4.<\/p>\n<p><span class=\"bwuline\">HER2-Positive Metastatic Breast Cancer<br \/>\n<br \/><\/span><i>DESTINY-Breast09<br \/>\n<br \/><\/i>The safety of ENHERTU 5.4 mg\/kg in combination with pertuzumab was evaluated in DESTINY-Breast09, a randomized, three-arm, multicenter study including 763 patients with HER2-positive (IHC 3+ or ISH+) unresectable or metastatic breast cancer. Three hundred eighty-one patients received ENHERTU in combination with pertuzumab and 382 patients received THP (taxane [docetaxel or paclitaxel], trastuzumab, and pertuzumab). Among patients who received ENHERTU in combination with pertuzumab, the median duration of treatment was 22 months (range: 0.3 months to 44.5 months).<\/p>\n<p>\nSerious adverse reactions occurred in 27% of patients receiving ENHERTU in combination with pertuzumab. Serious adverse reactions in &gt;1% of patients were diarrhea, pneumonia, febrile neutropenia, hypokalemia, vomiting, ILD, pulmonary embolism, and sepsis. Fatalities due to adverse reactions occurred in 3.4% of patients including pneumonia (n=3), ILD (n=2), sepsis (n=2), pulmonary embolism, septic shock, acute kidney injury, dyspnea, febrile neutropenia, and intestinal ischemia (1 patient each).<\/p>\n<p>\nENHERTU was discontinued for adverse reactions in 21% of patients. The most frequent adverse reaction (&gt;2%) associated with permanent discontinuation was ILD\/pneumonitis (6%). Dose interruptions due to adverse reactions occurred in 69% of patients. The most frequent adverse reactions (&gt;2%) associated with dose interruption were COVID-19, neutropenia, upper respiratory tract infection, fatigue, anemia, hypokalemia, ILD\/pneumonitis, thrombocytopenia, pneumonia, diarrhea, transaminase increased, leukopenia, cough, pyrexia, decreased appetite, and blood bilirubin increased. Dose reductions occurred in 46% of patients treated with ENHERTU in combination with pertuzumab. The most frequent adverse reactions (&gt;2%) associated with dose reduction were fatigue, neutropenia, nausea, diarrhea, ILD\/pneumonitis, thrombocytopenia, vomiting, transaminases increased, decreased weight, febrile neutropenia, and hypokalemia.<\/p>\n<p>\nThe most common (\u226520%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (87%), decreased hemoglobin (80%), decreased neutrophil count (78%), nausea (75%), increased alanine aminotransferase (66%), diarrhea (64%), increased aspartate aminotransferase (62%), decreased lymphocyte count (62%), decreased platelet count (56%), increased blood alkaline phosphatase (55%), decreased blood potassium (54%), fatigue (53%), alopecia (48%), vomiting (46%), upper respiratory tract infection (33%), constipation (33%), decreased appetite (32%), decreased weight (30%), COVID-19 (28%), musculoskeletal pain (24%), increased blood bilirubin (23%), and abdominal pain (23%).<\/p>\n<p><i>DESTINY-Breast03<br \/>\n<br \/><\/i>The safety of ENHERTU was evaluated in 257 patients with unresectable or metastatic HER2-positive breast cancer who received at least 1 dose of ENHERTU 5.4 mg\/kg intravenously once every 3 weeks in DESTINY-Breast03. The median duration of treatment was 14 months (range: 0.7 to 30) for patients who received ENHERTU.<\/p>\n<p>\nSerious adverse reactions occurred in 19% of patients receiving ENHERTU. Serious adverse reactions in &gt;1% of patients who received ENHERTU were vomiting, ILD, pneumonia, pyrexia, and urinary tract infection. Fatalities due to adverse reactions occurred in 0.8% of patients including COVID-19 and sudden death (1 patient each).<\/p>\n<p>\nENHERTU was permanently discontinued in 14% of patients, of which ILD\/pneumonitis accounted for 8%. Dose interruptions due to adverse reactions occurred in 44% of patients treated with ENHERTU. The most frequent adverse reactions (&gt;2%) associated with dose interruption were neutropenia, leukopenia, anemia, thrombocytopenia, pneumonia, nausea, fatigue, and ILD\/pneumonitis. Dose reductions occurred in 21% of patients treated with ENHERTU. The most frequent adverse reactions (&gt;2%) associated with dose reduction were nausea, neutropenia, and fatigue.<\/p>\n<p>\nThe most common (\u226520%) adverse reactions, including laboratory abnormalities, were nausea (76%), decreased white blood cell count (74%), decreased neutrophil count (70%), increased aspartate aminotransferase (67%), decreased hemoglobin (64%), decreased lymphocyte count (55%), increased alanine aminotransferase (53%), decreased platelet count (52%), fatigue (49%), vomiting (49%), increased blood alkaline phosphatase (49%), alopecia (37%), decreased blood potassium (35%), constipation (34%), musculoskeletal pain (31%), diarrhea (29%), decreased appetite (29%), headache (22%), respiratory infection (22%), abdominal pain (21%), increased blood bilirubin (20%), and stomatitis (20%).<\/p>\n<p><span class=\"bwuline\">HER2-Low and HER2-Ultralow Metastatic Breast Cancer<br \/>\n<br \/><\/span><i>DESTINY-Breast06<br \/>\n<br \/><\/i>The safety of ENHERTU was evaluated in 434 patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+\/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer who received ENHERTU 5.4 mg\/kg intravenously once every 3 weeks in DESTINY-Breast06. The median duration of treatment was 11 months (range: 0.4 to 39.6) for patients who received ENHERTU.<\/p>\n<p>\nSerious adverse reactions occurred in 20% of patients receiving ENHERTU. Serious adverse reactions in &gt;1% of patients who received ENHERTU were ILD\/pneumonitis, COVID-19, febrile neutropenia, and hypokalemia. Fatalities due to adverse reactions occurred in 2.8% of patients including ILD (0.7%); sepsis (0.5%); and COVID-19 pneumonia, bacterial meningoencephalitis, neutropenic sepsis, peritonitis, cerebrovascular accident, general physical health deterioration (0.2% each).<\/p>\n<p>\nENHERTU was permanently discontinued in 14% of patients. The most frequent adverse reaction (&gt;2%) associated with permanent discontinuation was ILD\/pneumonitis. Dose interruptions due to adverse reactions occurred in 48% of patients treated with ENHERTU. The most frequent adverse reactions (&gt;2%) associated with dose interruption were COVID-19, decreased neutrophil count, anemia, pyrexia, pneumonia, decreased white blood cell count, and ILD. Dose reductions occurred in 25% of patients treated with ENHERTU. The most frequent adverse reactions (&gt;2%) associated with dose reduction were nausea, fatigue, decreased platelet count, and decreased neutrophil count.<\/p>\n<p>\nThe most common (\u226520%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (86%), decreased neutrophil count (75%), nausea (70%), decreased hemoglobin (69%), decreased lymphocyte count (66%), fatigue (53%), decreased platelet count (48%), alopecia (48%), increased alanine aminotransferase (44%), increased blood alkaline phosphatase (43%), increased aspartate aminotransferase (41%), decreased blood potassium (35%), diarrhea (34%), vomiting (34%), constipation (32%), decreased appetite (26%), COVID-19 (26%), and musculoskeletal pain (24%).<\/p>\n<p><i>DESTINY-Breast04<br \/>\n<br \/><\/i>The safety of ENHERTU was evaluated in 371 patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+\/ISH-) breast cancer who received ENHERTU 5.4 mg\/kg intravenously once every 3 weeks in DESTINY-Breast04. The median duration of treatment was 8 months (range: 0.2 to 33) for patients who received ENHERTU.<\/p>\n<p>\nSerious adverse reactions occurred in 28% of patients receiving ENHERTU. Serious adverse reactions in &gt;1% of patients who received ENHERTU were ILD\/pneumonitis, pneumonia, dyspnea, musculoskeletal pain, sepsis, anemia, febrile neutropenia, hypercalcemia, nausea, pyrexia, and vomiting. Fatalities due to adverse reactions occurred in 4% of patients including ILD\/pneumonitis (3 patients); sepsis (2 patients); and ischemic colitis, disseminated intravascular coagulation, dyspnea, febrile neutropenia, general physical health deterioration, pleural effusion, and respiratory failure (1 patient each).<\/p>\n<p>\nENHERTU was permanently discontinued in 16% of patients, of which ILD\/pneumonitis accounted for 8%. Dose interruptions due to adverse reactions occurred in 39% of patients treated with ENHERTU. The most frequent adverse reactions (&gt;2%) associated with dose interruption were neutropenia, fatigue, anemia, leukopenia, COVID-19, ILD\/pneumonitis, increased transaminases, and hyperbilirubinemia. Dose reductions occurred in 23% of patients treated with ENHERTU. The most frequent adverse reactions (&gt;2%) associated with dose reduction were fatigue, nausea, thrombocytopenia, and neutropenia.<\/p>\n<p>\nThe most common (\u226520%) adverse reactions, including laboratory abnormalities, were nausea (76%), decreased white blood cell count (70%), decreased hemoglobin (64%), decreased neutrophil count (64%), decreased lymphocyte count (55%), fatigue (54%), decreased platelet count (44%), alopecia (40%), vomiting (40%), increased aspartate aminotransferase (38%), increased alanine aminotransferase (36%), constipation (34%), increased blood alkaline phosphatase (34%), decreased appetite (32%), musculoskeletal pain (32%), diarrhea (27%), and decreased blood potassium (25%).<\/p>\n<p><span class=\"bwuline\">HER2-Mutant Unresectable or Metastatic NSCLC (5.4 mg\/kg)<br \/>\n<br \/><\/span>DESTINY-Lung02 evaluated 2 dose levels (5.4 mg\/kg [n=101] and 6.4 mg\/kg [n=50]); however, only the results for the recommended dose of 5.4 mg\/kg intravenously every 3 weeks are described below due to increased toxicity observed with the higher dose in patients with NSCLC, including ILD\/pneumonitis.<\/p>\n<p>\nThe safety of ENHERTU was evaluated in 101 patients with HER2-mutant unresectable or metastatic NSCLC who received ENHERTU 5.4 mg\/kg intravenously once every 3 weeks until disease progression or unacceptable toxicity in DESTINY\u2011Lung02. The median duration of treatment was 8 months (range: 0.7 to 28) for patients who received ENHERTU.<\/p>\n<p>\nSerious adverse reactions occurred in 40% of patients receiving ENHERTU. Serious adverse reactions in &gt;1% of patients who received ENHERTU were ILD\/pneumonitis, pleural effusion, thrombocytopenia, dyspnea, nausea, pneumonia, vomiting, myocarditis, pulmonary embolism, and increased troponin I. Fatalities due to adverse reactions occurred in 3% of patients including ILD\/pneumonitis, cerebrovascular accident, and pneumococcal sepsis (1 patient each).<\/p>\n<p>\nENHERTU was permanently discontinued in 17% of patients. Adverse reactions which resulted in permanent discontinuation of ENHERTU were ILD\/pneumonitis, pneumonia, blood bilirubin increased, hypokalemia, metastases to meninges, and myocarditis. Dose interruptions of ENHERTU due to adverse reactions occurred in 50% of patients. Adverse reactions which required dose interruption (&gt;2%) included neutropenia, COVID-19, ILD\/pneumonitis, fatigue, anemia, and pneumonia. Dose reductions due to an adverse reaction occurred in 20% of patients. The most frequent adverse reactions (&gt;2%) associated with dose reduction were neutropenia, fatigue, and decreased appetite.<\/p>\n<p>\nThe most common (\u226520%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (68%), nausea (67%), decreased white blood cell count (66%), decreased neutrophil count (59%), decreased lymphocyte count (56%), increased aspartate aminotransferase (51%), decreased albumin (50%), decreased platelet count (49%), fatigue (48%), increased alanine aminotransferase (41%), decreased appetite (41%), constipation (38%), increased alkaline phosphatase (37%), vomiting (32%), decreased blood potassium (29%), diarrhea (24%), alopecia (22%), and musculoskeletal pain (21%).<\/p>\n<p><span class=\"bwuline\">HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg\/kg)<br \/>\n<br \/><\/span>The safety of ENHERTU was evaluated in 187 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma in DESTINY-Gastric01. Patients intravenously received at least 1 dose of either ENHERTU (N=125) 6.4 mg\/kg every 3 weeks or either irinotecan (N=55) 150 mg\/m<sup>2<\/sup> biweekly or paclitaxel (N=7) 80 mg\/m<sup>2<\/sup> weekly for 3 weeks. The median duration of treatment was 4.6 months (range: 0.7 to 22.3) for patients who received ENHERTU.<\/p>\n<p>\nSerious adverse reactions occurred in 44% of patients receiving ENHERTU 6.4 mg\/kg. Serious adverse reactions in &gt;2% of patients who received ENHERTU were decreased appetite, ILD, anemia, dehydration, pneumonia, cholestatic jaundice, pyrexia, and tumor hemorrhage. Fatalities due to adverse reactions occurred in 2.4% of patients: disseminated intravascular coagulation, large intestine perforation, and pneumonia occurred in 1 patient each (0.8%).<\/p>\n<p>\nENHERTU was permanently discontinued in 15% of patients, of which ILD accounted for 6%. Dose interruptions due to adverse reactions occurred in 62% of patients treated with ENHERTU. The most frequent adverse reactions (&gt;2%) associated with dose interruption were neutropenia, anemia, decreased appetite, leukopenia, fatigue, thrombocytopenia, ILD, pneumonia, lymphopenia, upper respiratory tract infection, diarrhea, and decreased blood potassium. Dose reductions occurred in 32% of patients treated with ENHERTU. The most frequent adverse reactions (&gt;2%) associated with dose reduction were neutropenia, decreased appetite, fatigue, nausea, and febrile neutropenia.<\/p>\n<p>\nThe most common (\u226520%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (75%), decreased white blood cell count (74%), decreased neutrophil count (72%), decreased lymphocyte count (70%), decreased platelet count (68%), nausea (63%), decreased appetite (60%), increased aspartate aminotransferase (58%), fatigue (55%), increased blood alkaline phosphatase (54%), increased alanine aminotransferase (47%), diarrhea (32%), decreased blood potassium (30%), vomiting (26%), constipation (24%), increased blood bilirubin (24%), pyrexia (24%), and alopecia (22%).<\/p>\n<p><span class=\"bwuline\">HER2-Positive (IHC 3+) Unresectable or Metastatic Solid Tumors<br \/>\n<br \/><\/span>The safety of ENHERTU was evaluated in 347 adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who received ENHERTU 5.4 mg\/kg intravenously once every 3 weeks in DESTINY-Breast01, DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02. The median duration of treatment was 8.3 months (range 0.7 to 30.2).<\/p>\n<p>\nSerious adverse reactions occurred in 34% of patients receiving ENHERTU. Serious adverse reactions in &gt;1% of patients who received ENHERTU were sepsis, pneumonia, vomiting, urinary tract infection, abdominal pain, nausea, pneumonitis, pleural effusion, hemorrhage, COVID-19, fatigue, acute kidney injury, anemia, cellulitis, and dyspnea. Fatalities due to adverse reactions occurred in 6.3% of patients including ILD\/pneumonitis (2.3%), cardiac arrest (0.6%), COVID-19 (0.6%), and sepsis (0.6%). The following events occurred in 1 patient each (0.3%): acute kidney injury, cerebrovascular accident, general physical health deterioration, pneumonia, and hemorrhagic shock.<\/p>\n<p>\nENHERTU was permanently discontinued in 15% of patients, of which ILD\/pneumonitis accounted for 10%. Dose interruptions due to adverse reactions occurred in 48% of patients. The most frequent adverse reactions (&gt;2%) associated with dose interruption were decreased neutrophil count, anemia, COVID-19, fatigue, decreased white blood cell count, and ILD\/pneumonitis. Dose reductions occurred in 27% of patients treated with ENHERTU. The most frequent adverse reactions (&gt;2%) associated with dose reduction were fatigue, nausea, decreased neutrophil count, ILD\/pneumonitis, and diarrhea.<\/p>\n<p>\nThe most common (\u226520%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (75%), nausea (69%), decreased hemoglobin (67%), decreased neutrophil count (66%), fatigue (59%), decreased lymphocyte count (58%), decreased platelet count (51%), increased aspartate aminotransferase (45%), increased alanine aminotransferase (44%), increased blood alkaline phosphatase (36%), vomiting (35%), decreased appetite (34%), alopecia (34%), diarrhea (31%), decreased blood potassium (29%), constipation (28%), decreased sodium (22%), stomatitis (20%), and upper respiratory tract infection (20%).<\/p>\n<p><b>Use in Specific Populations<\/b><\/p>\n<ul class=\"bwlistdisc\">\n<li><b>Pregnancy:<\/b> ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. There are clinical considerations if ENHERTU is used in pregnant women, or if a patient becomes pregnant within 7 months after the last dose of ENHERTU.\n<\/li>\n<li><b>Lactation:<\/b> There are no data regarding the presence of ENHERTU in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with ENHERTU and for 7 months after the last dose.\n<\/li>\n<li><b>Females and Males of Reproductive Potential:<\/b><span class=\"bwuline\">Pregnancy testing<\/span>: Verify pregnancy status of females of reproductive potential prior to initiation of ENHERTU. <span class=\"bwuline\">Contraception<\/span>: <i>Females<\/i>: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with ENHERTU and for 7 months after the last dose. <i>Males<\/i>: Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for 4 months after the last dose. <span class=\"bwuline\">Infertility<\/span>: ENHERTU may impair male reproductive function and fertility.\n<\/li>\n<li><b>Pediatric Use:<\/b> Safety and effectiveness of ENHERTU have not been established in pediatric patients.\n<\/li>\n<li><b>Geriatric Use: <\/b><i>ENHERTU as Monotherapy<\/i>:<i \/>Of the 2233 patients treated with ENHERTU 5.4 mg\/kg, 28% were \u226565 years and 6% were \u226575 years. No overall differences in efficacy within clinical studies were observed between patients \u226565 years compared to younger patients. There was a higher incidence of Grade 3-4 adverse reactions observed in patients aged \u226565 years (56%) as compared to younger patients (49%). Of the 125 patients with HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg\/kg in DESTINY-Gastric01, 56% were \u226565 years and 14% were \u226575 years. No overall differences in efficacy or safety were observed between patients \u226565 years of age compared to younger patients. <i>ENHERTU in Combination with Pertuzumab<\/i>:<i \/>In patients with HER2-positive unresectable or metastatic breast cancer treated with ENHERTU 5.4 mg\/kg in combination with pertuzumab (N=431), 17% were \u226565 years and 3% were \u226575 years. No overall differences in efficacy or safety were observed between patients \u226565 years compared to younger patients. <i>ENHERTU followed by THP<\/i>: Of the 320 patients with HER2-positive early breast cancer treated with ENHERTU 5.4 mg\/kg followed by THP, 12% were \u226565 years and 1.6% were \u226575 years. No overall differences in efficacy were observed between patients \u226565 years compared to younger patients. There was a higher incidence of Grade 3-4 adverse reactions observed in patients \u226565 years (38%) as compared to younger patients (30%).\n<\/li>\n<li><b>Renal Impairment:<\/b> A higher incidence of Grade 1 and 2 ILD\/pneumonitis has been observed in patients with moderate renal impairment. Monitor patients with moderate renal impairment more frequently. The recommended dosage of ENHERTU has not been established for patients with severe renal impairment (CLcr &lt;30 mL\/min).\n<\/li>\n<li><b>Hepatic Impairment:<\/b> In patients with moderate hepatic impairment, due to potentially increased exposure, monitor for increased adverse reactions related to the topoisomerase inhibitor, DXd. The recommended dosage of ENHERTU has not been established for patients with severe hepatic impairment (total bilirubin &gt;3 times ULN and any AST).\n<\/li>\n<\/ul>\n<p><b>To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or <\/b><a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Ffda.gov%2Fmedwatch&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=fda.gov%2Fmedwatch&amp;index=1&amp;md5=42c1155366ff61f73541522452abf7b9\"><b>fda.gov\/medwatch<\/b><\/a><b>.<\/b><\/p>\n<p><b>Please see accompanying full <\/b><a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fdsi.com%2Fprescribing-information-portlet%2FgetPIContent%3FproductName%3DEnhertu%26inline%3Dtrue&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=Prescribing+Information&amp;index=2&amp;md5=d22665e7a6509db225a4ee79d4b47226\"><b>Prescribing Information<\/b><\/a><b>, including Boxed WARNINGS, and <\/b><a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fdsi.com%2Fprescribing-information-portlet%2FgetPIContent%3FproductName%3DEnhertu_Med%26inline%3Dtrue&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=Medication+Guide&amp;index=3&amp;md5=04924d713350ad0b87049b3782f9d61b\"><b>Medication Guide<\/b><\/a><b>.<\/b><\/p>\n<p><b><span class=\"bwuline\">Notes<\/span><\/b><\/p>\n<p><b><i>HER2<\/i>-mutant NSCLC<br \/>\n<br \/><\/b>Lung cancer is the most commonly diagnosed cancer globally and remains the leading cause of cancer-related death in both men and women.<sup>11<\/sup> In 2024, approximately 2.6 million new lung cancer cases were reported worldwide, with an estimated 1.8 million deaths.<sup>11<\/sup> NSCLC is the most common type of lung cancer, accounting for approximately 85% of cases.<sup>12<\/sup> Prognosis is particularly poor for patients with metastatic NSCLC as only approximately 10% will live beyond five years after diagnosis.<sup>13-15<\/sup><\/p>\n<p>\nHER2 is a tyrosine kinase receptor protein involved in cell growth and differentiation and expressed on the surface of multiple tumor types. <i>HER2 <\/i>mutations have been identified in NSCLC as distinct molecular targets and have been reported in approximately 2-4% of patients with non-squamous NSCLC.<sup>8-10<\/sup> These <i>HER2 <\/i>mutations are predominantly seen in younger women and people with no smoking history and have been independently associated with cancer cell growth and poor prognosis, with an increased incidence of brain metastases.<sup>8,16-20<\/sup><\/p>\n<p>\nThe global standard of care in the 1st-line metastatic setting for patients with <i>HER2-<\/i>mutant NSCLC is a combination of immunotherapy and platinum-based chemotherapy.<sup>1-3<\/sup> While these treatment regimens have been shown to improve survival in NSCLC, many patients do not respond to 1st-line treatment and experience disease progression, underscoring the need for additional treatment options.<sup>3-7<\/sup><\/p>\n<p><b>DESTINY-Lung04<br \/>\n<br \/><\/b>DESTINY-Lung04 is a global, randomized, open-label, Phase III trial evaluating the efficacy and safety of ENHERTU (5.4mg\/kg) compared to standard of care (platinum-pemetrexed doublet chemotherapy in combination with pembrolizumab) in patients with unresectable, locally advanced or metastatic, non-squamous NSCLC harboring a <i>HER2 <\/i>exon 19 or 20 mutation.<\/p>\n<p>\nPatients were randomized 1:1 to receive either ENHERTU or standard of care. Randomization was stratified by smoking history and presence or history of brain metastasis. The primary endpoint of DESTINY-Lung04 is PFS as assessed by blinded independent central review (BICR). Secondary endpoints include OS, investigator-assessed PFS, overall response rate and duration of response as assessed by BICR and investigator, pharmacokinetics and safety.<\/p>\n<p>\nDESTINY-Lung04 enrolled 454 patients across multiple sites in Asia, Europe and North America. For more information about the trial, visit <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT05048797&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=ClinicalTrials.gov&amp;index=4&amp;md5=daff11c8c01ba5eab7c0c6a36e7e5c94\">ClinicalTrials.gov<\/a>.<\/p>\n<p><b>ENHERTU<br \/>\n<br \/><\/b>ENHERTU is a HER2-directed ADC. Designed using the proprietary DXd ADC Technology of Daiichi Sankyo, ENHERTU<i \/>is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca\u2019s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.<\/p>\n<p>\nENHERTU (5.4mg\/kg) followed by THP is approved in the US, China, Singapore and India as a neoadjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer based on the results from the <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT05113251&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=DESTINY-Breast11&amp;index=5&amp;md5=992b91126ad747cf89fb52d87d3844ad\">DESTINY-Breast11<\/a> trial. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.<\/p>\n<p>\nENHERTU (5.4mg\/kg) is approved in Brazil and the US as an adjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following trastuzumab (with or without pertuzumab) and taxane-based treatment based on the <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04622319&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=DESTINY-Breast05&amp;index=6&amp;md5=913ac9f64a10357564e650decacd80ee\">DESTINY-Breast05<\/a> trial.<\/p>\n<p>\nENHERTU (5.4mg\/kg) in combination with pertuzumab is approved in more than ten countries as a 1st-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer based on the results from the <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04784715&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=DESTINY-Breast09&amp;index=7&amp;md5=af35b6c1f20756419b540fc48bc940e3\">DESTINY-Breast09<\/a> trial.<\/p>\n<p>\nENHERTU (5.4mg\/kg) is approved in more than 75 countries worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+\/ ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally authorized test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04494425&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=DESTINY-Breast06&amp;index=8&amp;md5=2c2529d45fc81abebcf11ab94a198733\">DESTINY-Breast06<\/a> trial.<\/p>\n<p>\nENHERTU (5.4mg\/kg) is approved in more than 100 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT03529110&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=DESTINY-Breast03&amp;index=9&amp;md5=43229c98cf5fc193c69649d4a13e68f1\">DESTINY-Breast03<\/a> trial.<\/p>\n<p>\nENHERTU (5.4mg\/kg) is approved in more than 100 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+\/ISH) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT03734029&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=DESTINY-Breast04&amp;index=10&amp;md5=1a1f99143e29f9ab2f4c248bf016d5d6\">DESTINY-Breast04<\/a> trial.<\/p>\n<p>\nENHERTU (5.4mg\/kg) is approved in more than 80 countries worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating <i>HER2 <\/i>(<i>ERBB2<\/i>) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT04644237&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=DESTINY-Lung02&amp;index=11&amp;md5=f912a6025647314a6d7431ed891708a7\">DESTINY-Lung02<\/a> and\/or <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT05246514&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=DESTINY-Lung05&amp;index=12&amp;md5=205bd362c201f150cb5f820e5ab746c1\">DESTINY-Lung05<\/a> trials. Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.<\/p>\n<p>\nENHERTU (6.4mg\/kg) is approved in more than 90 countries worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+\/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT03329690&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=DESTINY-Gastric01&amp;index=13&amp;md5=bc4fe9f6b4f2026e47eed29f7a2058f1\">DESTINY-Gastric01<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04014075&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=DESTINY-Gastric02&amp;index=14&amp;md5=e11d5cf34453d83107deef37c1a7ed4b\">DESTINY-Gastric02<\/a> and\/or <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04704934&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=DESTINY-Gastric04&amp;index=15&amp;md5=1ac05440d2fde4885f5da30dbbe54907\">DESTINY-Gastric04<\/a> trials.<\/p>\n<p>\nENHERTU (5.4mg\/kg) is approved in more than 45 countries\/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04482309&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=DESTINY-PanTumor02&amp;index=16&amp;md5=0c76c75583889d5309b3654dc5369641\">DESTINY-PanTumor02<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT03505710&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=DESTINY-Lung01&amp;index=17&amp;md5=a48342aa6b6242db1e689b53c3fa6295\">DESTINY-Lung01<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04744831&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=DESTINY-CRC02&amp;index=18&amp;md5=e0551bc7bbce863a7a1e8a23849b25a8\">DESTINY-CRC02<\/a> and\/or <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fjrct.mhlw.go.jp%2Fen-latest-detail%2FjRCT2080224635&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=HERALD&amp;index=19&amp;md5=c73205669bf95d2f1a6f1047b601f90f\">HERALD<\/a> trials. Continued approval in the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.<\/p>\n<p><b>ENHERTU clinical development program<br \/>\n<br \/><\/b>A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy, in combination or sequentially with other cancer medicines across multiple HER2-targetable cancers.<\/p>\n<p><b>Daiichi Sankyo collaboration<br \/>\n<br \/><\/b>AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialize ENHERTU in <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.astrazeneca.com%2Fmedia-centre%2Fpress-releases%2F2019%2Fastrazeneca-and-daiichi-sankyo-enter-collaboration-for-novel-her-2-targeting-antibody-drug-conjugate.html&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=March+2019&amp;index=20&amp;md5=8eaec365794bbf0deaff1a64cddc7575\">March 2019<\/a> and datopotamab deruxtecan-dlnk<b \/>in <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.astrazeneca.com%2Fmedia-centre%2Fpress-releases%2F2020%2Fastrazeneca-and-daiichi-sankyo-enter-collaboration-to-develop-and-commercialise-new-antibody-drug-conjugate.html%23%21&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=July+2020&amp;index=21&amp;md5=3c2deaae6db9e1926bfc73f6d7de3b07\">July 2020<\/a>, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and datopotamab deruxtecan-dlnk.<\/p>\n<p><b>AstraZeneca in lung cancer<br \/>\n<br \/><\/b>AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating innovative approaches, the Company aims to match medicines to the patients who can benefit most.<\/p>\n<p>\nThe Company\u2019s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including osimertinib and gefitinib;<i \/>durvalumab and tremelimumab; ENHERTU (trastuzumab deruxtecan) and datopotamab deruxtecan-dlnk in collaboration with Daiichi Sankyo; savolitinib in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action.<\/p>\n<p>\nAstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment.<\/p>\n<p><b>AstraZeneca in oncology<br \/>\n<br \/><\/b>AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.<\/p>\n<p>\nThe Company&#8217;s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.<\/p>\n<p>\nAstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.<\/p>\n<p><b>AstraZeneca<br \/>\n<br \/><\/b>AstraZeneca (LSE\/STO\/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal &amp; Metabolism, and Respiratory &amp; Immunology. Based in Cambridge, UK, AstraZeneca\u2019s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fnam11.safelinks.protection.outlook.com%2F%3Furl%3Dhttp%253A%252F%252Fwww.astrazeneca-us.com%252F%26data%3D05%257C02%257Cmpapoutsis%2540realchemistry.com%257Cc8b20ba5e3c549b7198908debda1e03c%257C6fa5bfc4f95843f8bb395d382689654b%257C0%257C0%257C639156700123336641%257CUnknown%257CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%253D%253D%257C0%257C%257C%257C%26sdata%3DjczFo2ri3168F7jjDKToAGQ8BRf6TTKy%252FpIedGurkms%253D%26reserved%3D0&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=astrazeneca-us.com&amp;index=22&amp;md5=35902f8d3118223f146301e248a78766\">astrazeneca-us.com<\/a> and follow the Company on social media <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fnam11.safelinks.protection.outlook.com%2F%3Furl%3Dhttps%253A%252F%252Fwww.linkedin.com%252Fcompany%252Fastrazeneca%26data%3D05%257C02%257Cmpapoutsis%2540realchemistry.com%257Cc8b20ba5e3c549b7198908debda1e03c%257C6fa5bfc4f95843f8bb395d382689654b%257C0%257C0%257C639156700123360855%257CUnknown%257CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%253D%253D%257C0%257C%257C%257C%26sdata%3D5zrzPoKa2SccW9hkcI0PxXj87N386kNefvOIn0lX%252BHo%253D%26reserved%3D0&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=%40AstraZeneca&amp;index=23&amp;md5=cbabfb5a1cbee5d5e3eab05d61ce6498\">@AstraZeneca<\/a>.<\/p>\n<p><b>References<\/b><\/p>\n<ol class=\"bwlistdecimal\">\n<li>\nHendriks LE, et al. Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. <i>Ann Oncol<\/i>. 2023;34(4):339-357.<\/p>\n<\/li>\n<li>\nNational Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. Version 5.2026. March 13, 2026. Available at: <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.nccn.org%2Fprofessionals%2Fphysician_gls%2Fpdf%2Fnscl.pdf&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=http%3A%2F%2Fwww.nccn.org%2Fprofessionals%2Fphysician_gls%2Fpdf%2Fnscl.pdf&amp;index=24&amp;md5=821789e33fbf0b0c81bdfc558fa0ea9d\">http:\/\/www.nccn.org\/professionals\/physician_gls\/pdf\/nscl.pdf<\/a>. Accessed August 2026.<\/p>\n<\/li>\n<li>\nMan J, et al. Response Rate and Survival at Key Timepoints With PD-1 Blockade vs Chemotherapy in PD-L1 Subgroups: Meta-Analysis of Metastatic NSCLC Trials. <i>JNCI Cancer<\/i><i>Spectr<\/i>. 2021;5(3):pkab012.<\/p>\n<\/li>\n<li>\nPaz-Ares L, et al. A Randomized, Placebo-Controlled Trial of Pembrolizumab Plus Chemotherapy in Patients With Metastatic Squamous NSCLC: Protocol-Specified Final Analysis of KEYNOTE-407. <i>J Thorac Oncol<\/i>. 2020 Oct;15(10):1657-1669.<\/p>\n<\/li>\n<li>\nMok TSK, et al. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. <i>Lancet<\/i>. 2019 May 4;393(10183):1819-1830.<\/p>\n<\/li>\n<li>\nRodr\u00edguez-Abreu D et al. Pemetrexed plus platinum with or without pembrolizumab in patients with previously untreated metastatic nonsquamous NSCLC: protocol-specified final analysis from KEYNOTE-189. <i>Ann Onc<\/i>. 2021 Jul;32(7):881-895.<\/p>\n<\/li>\n<li>\nBrahmer J.R. et al. KEYNOTE-024 5-year OS update: First-line (1L) pembrolizumab (pembro) vs platinum-based chemotherapy (chemo) in patients (pts) with metastatic NSCLC and PD-L1 tumour proportion score (TPS) \u226550%. <i>ESMO 2021 Virtual Congress<\/i>; Abstract LBA51.<\/p>\n<\/li>\n<li>\nMazieres J, et al. Lung Cancer That Harbors an <i>HER2<\/i> Mutation: Epidemiologic Characteristics and Therapeutic Perspectives. <i>J Clin Oncol<\/i>. 2013;31(16):1997-2003.<\/p>\n<\/li>\n<li>\ncBioPortal for Cancer Genomics. Available at: <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.cbioportal.org%2F&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.cbioportal.org%2F&amp;index=25&amp;md5=ede0ffb7024a6ded6b49ba417a78da09\">https:\/\/www.cbioportal.org\/<\/a>. Accessed August 2026.<\/p>\n<\/li>\n<li>\nYoshizawa A, et al. HER2 Status In Lung Adenocarcinoma: A Comparison Of Immunohistochemistry, Fluorescence In Situ Hybridization (FISH), Dual-ISH, and Gene Mutations. <i>Lung Cancer<\/i>. 2014;85(3):373-378.<\/p>\n<\/li>\n<li>\nWorld Health Organization. Lung Cancer Fact Sheet. Available at: <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fgco.iarc.who.int%2Ftoday%2Fen%2Ffact-sheets-cancers%2F15%2Ftrachea-bronchus-and-lung&amp;esheet=54589955&amp;newsitemid=20260817879631&amp;lan=en-US&amp;anchor=https%3A%2F%2Fgco.iarc.who.int%2Ftoday%2Fen%2Ffact-sheets-cancers%2F15%2Ftrachea-bronchus-and-lung&amp;index=26&amp;md5=d927f71b2d3abb192cc2703b921e0804\">https:\/\/gco.iarc.who.int\/today\/en\/fact-sheets-cancers\/15\/trachea-bronchus-and-lung<\/a>. Accessed August 2026.<\/p>\n<\/li>\n<li>\nLeiter A, et al. The global burden of lung cancer: current status and future trends. <i>Nat Rev Clin Oncol<\/i>. 2023;20(9):624\u2013639.<\/p>\n<\/li>\n<li>\nTamura T, et al. Specific organ metastases and survival in metastatic non-small-cell lung cancer. <i>Mol Clin Oncol<\/i>. 2015;3(1):217-221.<\/p>\n<\/li>\n<li>\nGoldstraw P, et al. The IASLC Lung Cancer Staging Project: Proposals for Revision of the TNM Stage Groupings in the Forthcoming (Eighth) Edition of the TNM Classification for Lung Cancer. <i>J Thorac Oncol<\/i>. 2016;11(1):39-51.<\/p>\n<\/li>\n<li>\nSiegel RL, et al. Cancer Statistics, 2021. <i>CA Cancer J Clin<\/i>. 2021;71(1):7-33.<\/p>\n<\/li>\n<li>\nLiu S, et al. Targeting HER2 Aberrations in Non\u2013Small Cell Lung Cancer with Osimertinib. <i>Clin Cancer Res<\/i>. 2018;24(11):2594-2604.<\/p>\n<\/li>\n<li>\nStephens P, et al. Lung cancer: intragenic ERBB2 kinase mutations in tumours. <i>Nature<\/i>. 2004;431:525-6.<\/p>\n<\/li>\n<li>\nArcila ME, et al. Prevalence, Clinicopathologic Associations, and Molecular Spectrum of ERBB2 (HER2) Tyrosine Kinase Mutations in Lung Adenocarcinomas. <i>Clin Cancer Res<\/i>. 2012;18:4910-8.<\/p>\n<\/li>\n<li>\nPillai RN, et al. <i>HER2<\/i> mutations in lung adenocarcinomas: A report from the Lung Cancer Mutation Consortium. <i>Cancer<\/i>. 2017;123:4099-105.<\/p>\n<\/li>\n<li>\nOffin M, et al. Frequency and outcomes of brain metastases in patients with HER2-mutant lung cancers. <i>Cancer<\/i>. 2019;125:4380-7.<\/p>\n<\/li>\n<\/ol>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20260817879631r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20260817879631\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20260817879631\/en\/<\/a><\/span><\/p>\n<p><b>Media Inquiries<br \/>\n<br \/><\/b>Lauren-Jei McCarthy\u00a0+1 347 918 7001<br \/>\n<br \/>US Media Mailbox: <a rel=\"nofollow\" href=\"mailto:usmediateam@astrazeneca.com\">usmediateam@astrazeneca.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> Delaware United States North America<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Oncology Health Clinical Trials Research Science Pharmaceutical Biotechnology<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20260817879631\/en\/2301168\/3\/original.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>ENHERTU\u00ae (fam-trastuzumab deruxtecan-nxki) demonstrated statistically significant and clinically meaningful improvement in PFS as 1st-line treatment of patients with HER2-mutant advanced non-small cell lung cancer in DESTINY-Lung04 Phase III trial AstraZeneca and Daiichi Sankyo\u2019s ENHERTU is the first and only HER2-directed medicine to improve progression-free survival over global standard of care in a Phase III trial in this setting WILMINGTON, Del.&#8211;(BUSINESS WIRE)&#8211; Positive high-level results from the DESTINY-Lung04 Phase III trial showed ENHERTU\u00ae (fam-trastuzumab deruxtecan-nxki) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus global standard of care (platinum-pemetrexed doublet chemotherapy plus pembrolizumab) as 1st-line treatment of patients with unresectable, locally advanced or metastatic HER2-mutant non-squamous non-small cell lung cancer (NSCLC). The trial will continue as planned &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/enhertu-fam-trastuzumab-deruxtecan-nxki-demonstrated-statistically-significant-and-clinically-meaningful-improvement-in-pfs-as-1st-line-treatment-of-patients-with-her2-mutant-advanced-non-smal\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;ENHERTU\u00ae (fam-trastuzumab deruxtecan-nxki) demonstrated statistically significant and clinically meaningful improvement in PFS as 1st-line treatment of patients with HER2-mutant advanced non-small cell lung cancer in DESTINY-Lung04 Phase III trial&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-995853","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ENHERTU\u00ae (fam-trastuzumab deruxtecan-nxki) demonstrated statistically significant and clinically meaningful improvement in PFS as 1st-line treatment of patients with HER2-mutant advanced non-small cell lung cancer in DESTINY-Lung04 Phase III trial - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/enhertu-fam-trastuzumab-deruxtecan-nxki-demonstrated-statistically-significant-and-clinically-meaningful-improvement-in-pfs-as-1st-line-treatment-of-patients-with-her2-mutant-advanced-non-smal\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ENHERTU\u00ae (fam-trastuzumab deruxtecan-nxki) demonstrated statistically significant and clinically meaningful improvement in PFS as 1st-line treatment of patients with HER2-mutant advanced non-small cell lung cancer in DESTINY-Lung04 Phase III trial - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"ENHERTU\u00ae (fam-trastuzumab deruxtecan-nxki) demonstrated statistically significant and clinically meaningful improvement in PFS as 1st-line treatment of patients with HER2-mutant advanced non-small cell lung cancer in DESTINY-Lung04 Phase III trial AstraZeneca and Daiichi Sankyo\u2019s ENHERTU is the first and only HER2-directed medicine to improve progression-free survival over global standard of care in a Phase III trial in this setting WILMINGTON, Del.&#8211;(BUSINESS WIRE)&#8211; Positive high-level results from the DESTINY-Lung04 Phase III trial showed ENHERTU\u00ae (fam-trastuzumab deruxtecan-nxki) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus global standard of care (platinum-pemetrexed doublet chemotherapy plus pembrolizumab) as 1st-line treatment of patients with unresectable, locally advanced or metastatic HER2-mutant non-squamous non-small cell lung cancer (NSCLC). The trial will continue as planned &hellip; Continue reading &quot;ENHERTU\u00ae (fam-trastuzumab deruxtecan-nxki) demonstrated statistically significant and clinically meaningful improvement in PFS as 1st-line treatment of patients with HER2-mutant advanced non-small cell lung cancer in DESTINY-Lung04 Phase III trial&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/enhertu-fam-trastuzumab-deruxtecan-nxki-demonstrated-statistically-significant-and-clinically-meaningful-improvement-in-pfs-as-1st-line-treatment-of-patients-with-her2-mutant-advanced-non-smal\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-08-17T11:33:57+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20260817879631r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"36 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/enhertu-fam-trastuzumab-deruxtecan-nxki-demonstrated-statistically-significant-and-clinically-meaningful-improvement-in-pfs-as-1st-line-treatment-of-patients-with-her2-mutant-advanced-non-smal\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/enhertu-fam-trastuzumab-deruxtecan-nxki-demonstrated-statistically-significant-and-clinically-meaningful-improvement-in-pfs-as-1st-line-treatment-of-patients-with-her2-mutant-advanced-non-smal\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"ENHERTU\u00ae (fam-trastuzumab deruxtecan-nxki) demonstrated statistically significant and clinically meaningful improvement in PFS as 1st-line treatment of patients with HER2-mutant advanced non-small cell lung cancer in DESTINY-Lung04 Phase III trial\",\"datePublished\":\"2026-08-17T11:33:57+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/enhertu-fam-trastuzumab-deruxtecan-nxki-demonstrated-statistically-significant-and-clinically-meaningful-improvement-in-pfs-as-1st-line-treatment-of-patients-with-her2-mutant-advanced-non-smal\\\/\"},\"wordCount\":7293,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/enhertu-fam-trastuzumab-deruxtecan-nxki-demonstrated-statistically-significant-and-clinically-meaningful-improvement-in-pfs-as-1st-line-treatment-of-patients-with-her2-mutant-advanced-non-smal\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&amp;sty=20260817879631r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/enhertu-fam-trastuzumab-deruxtecan-nxki-demonstrated-statistically-significant-and-clinically-meaningful-improvement-in-pfs-as-1st-line-treatment-of-patients-with-her2-mutant-advanced-non-smal\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/enhertu-fam-trastuzumab-deruxtecan-nxki-demonstrated-statistically-significant-and-clinically-meaningful-improvement-in-pfs-as-1st-line-treatment-of-patients-with-her2-mutant-advanced-non-smal\\\/\",\"name\":\"ENHERTU\u00ae (fam-trastuzumab deruxtecan-nxki) demonstrated statistically significant and clinically meaningful improvement in PFS as 1st-line treatment of patients with HER2-mutant advanced non-small cell lung cancer in DESTINY-Lung04 Phase III trial - 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