{"id":813466,"date":"2025-02-14T11:13:10","date_gmt":"2025-02-14T16:13:10","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/imfinzi-durvalumab-perioperative-regimen-improved-event-free-survival-and-overall-survival-across-muscle-invasive-bladder-cancer-patients-regardless-of-complete-pathology-response-status-in-po\/"},"modified":"2025-02-14T11:13:10","modified_gmt":"2025-02-14T16:13:10","slug":"imfinzi-durvalumab-perioperative-regimen-improved-event-free-survival-and-overall-survival-across-muscle-invasive-bladder-cancer-patients-regardless-of-complete-pathology-response-status-in-po","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/imfinzi-durvalumab-perioperative-regimen-improved-event-free-survival-and-overall-survival-across-muscle-invasive-bladder-cancer-patients-regardless-of-complete-pathology-response-status-in-po\/","title":{"rendered":"IMFINZI\u00ae (durvalumab) perioperative regimen improved event-free survival and overall survival across muscle-invasive bladder cancer patients regardless of complete pathology response status in post-hoc exploratory analysis of NIAGARA Phase III trial"},"content":{"rendered":"

<\/p>\n

IMFINZI\u00ae (durvalumab) perioperative regimen improved event-free survival and overall survival across muscle-invasive bladder cancer patients regardless of complete pathology response status in post-hoc exploratory analysis of NIAGARA Phase III trial<\/b><\/p>\n

IMFINZI reduced the risk of distant metastases and death from bladder cancer <\/i>vs. neoadjuvant chemotherapy alone<\/i><\/b><\/p>\n

WILMINGTON, Del.–(BUSINESS WIRE<\/a>)–
\nResults from a post-hoc exploratory subgroup analysis from the NIAGARA Phase III trial showed AstraZeneca\u2019s IMFINZI\u00ae<\/sup>(durvalumab), administered perioperatively in combination with neoadjuvant chemotherapy, demonstrated improvements in event-free survival (EFS) and overall survival (OS) versus neoadjuvant chemotherapy with radical cystectomy alone in patients with or without a pathologic complete response (pCR) in muscle-invasive bladder cancer (MIBC). Patients were treated with four cycles of IMFINZI in combination with neoadjuvant chemotherapy before radical cystectomy (surgery to remove the bladder) followed by eight cycles of IMFINZI monotherapy.<\/p>\n

\nThese new data were presented today at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in San Francisco, California (abstract #659).<\/p>\n

\nIn NIAGARA, treatment with the IMFINZI perioperative regimen improved EFS and OS versus the comparator arm both in patients who achieved pCR and those who did not. This regimen reduced the risk of disease progression, recurrence, not undergoing surgery, or death by 42% in patients who achieved pCR and by 23% in those who did not; and reduced the risk of death by 28% in patients who achieved pCR and by 16% in those who did not (see data table below for details).<\/p>\n

\nThe IMFINZIperioperative regimen also improved metastasis-free survival (MFS) and disease-specific survival (DSS), two secondary endpoints, versus the comparator arm in the intent-to-treat (ITT) population. This regimen reduced the risk of developing distant metastases or death by 33% and the risk of death specifically due to bladder cancer by 31% versus the comparator arm (see data table below for details).<\/p>\n

\nMatthew ND. Galsky, Lillian and Howard Stratton Professor of Medicine, Director of Genitourinary Medical Oncology, The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, New York, and NIAGARA Investigator and Steering Committee member, said: \u201cThese NIAGARA data confirm the compelling efficacy of the durvalumab perioperative regimen in muscle-invasive bladder cancer, and importantly, show this regimen improved outcomes regardless of whether patients achieved a pathologic complete response. This insight, together with the data showing the durvalumab perioperative regimen extended the time patients live before distant metastases develop, is favorable news for patients with muscle-invasive bladder cancer who are in need of better treatment options.\u201d<\/p>\n

\nCristian Massacesi, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca, said: \u201cNIAGARA was the first Phase III trial of a perioperative immunotherapy regimen in muscle-invasive bladder cancer to show statistically significant and clinically meaningful improvements in event-free and overall survival. The 33 percent reduction in the risk of distant metastases, which are associated with a poorer prognosis, further reinforces the potential of perioperative IMFINZIto become a new standard of care in this setting.\u201d<\/p>\n

\nThese new data build on findings presented<\/a> at the European Society for Medical Oncology (ESMO) Congress and published in The New England Journal of Medicine<\/i><\/a> which showed NIAGARA met the primary endpoint of EFS and the key secondary endpoint of OS. In the ITT population, patients treated with the IMFINZI perioperative regimen showed a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus the comparator arm, as well as a 25% reduction in the risk of death. There was also a 10% improvement in the pCR rate versus the comparator arm.<\/p>\n

Summary of exploratory post-hoc analysis: NIAGARA<\/b><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

\n\u00a0<\/p>\n<\/td>\n

\n

Patients with pCR<\/b><\/p>\n<\/td>\n

\n

Patients without pCR<\/b><\/p>\n<\/td>\n

\n

ITT population<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\n\u00a0<\/p>\n<\/td>\n

\n

\nIMFINZI-
\n
based
\n
regimen
\n
(n=199)<\/p>\n<\/td>\n

\n

\nNeoadjuvant
\n
chemotherapy
\n
(n=146)<\/p>\n<\/td>\n

\n

\nIMFINZI-
\n
based
\n
regimen
\n
(n=334)<\/p>\n<\/td>\n

\n

\nNeoadjuvant
\n
chemotherapy
\n
(n=384)<\/p>\n<\/td>\n

\n

\nIMFINZI-
\n
based
\n
regimen
\n
(n=533)<\/p>\n<\/td>\n

\n

\nNeoadjuvant
\n
chemotherapy
\n
(n=530)<\/p>\n<\/td>\n<\/tr>\n

\n

pCRi<\/sup><\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\npCR rate
\n
(%)<\/p>\n<\/td>\n

\n

\n–<\/p>\n<\/td>\n

\n

\n–<\/p>\n<\/td>\n

\n

\n–<\/p>\n<\/td>\n

\n

\n–<\/p>\n<\/td>\n

\n

\n37.3<\/p>\n<\/td>\n

\n

\n27.5<\/p>\n<\/td>\n<\/tr>\n

\n

\np-valueii<\/sup><\/p>\n<\/td>\n

\n

\n–<\/p>\n<\/td>\n

\n

\n–<\/p>\n<\/td>\n

\n

\n0.0005<\/p>\n<\/td>\n<\/tr>\n

\n

EFSi<\/sup><\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\nEFS rate,<\/p>\n<\/td>\n

\n

\n\u00a0<\/p>\n<\/td>\n

\n\n\n\n<\/tr>\n
\n

\n24 months<\/p>\n<\/td>\n

\n

\n92.1<\/p>\n<\/td>\n

85.8<\/td>\n53.3<\/td>\n49.5<\/td>\n67.8<\/td>\n59.8<\/td>\n<\/tr>\n
\n

\n(%)<\/p>\n<\/td>\n

\n\n\n\n\n<\/tr>\n
\n

\nHR (95%<\/p>\n<\/td>\n

\n

\n0.58<\/p>\n<\/td>\n

\n

\n0.77<\/p>\n<\/td>\n

\n

\n0.68<\/p>\n<\/td>\n<\/tr>\n

\n

\nCI)<\/p>\n<\/td>\n

\n

\n(0.33-1.00)<\/p>\n<\/td>\n

\n

\n(0.63-0.95)<\/p>\n<\/td>\n

\n

\n(0.56-0.82)<\/p>\n<\/td>\n<\/tr>\n

\n

OSi<\/sup><\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\nOS rate, 24
\n
months (%)<\/p>\n<\/td>\n

\n

\n95.5<\/p>\n<\/td>\n

\n

\n91.1<\/p>\n<\/td>\n

\n

\n74.1<\/p>\n<\/td>\n

\n

\n68.9<\/p>\n<\/td>\n

\n

\n82.2<\/p>\n<\/td>\n

\n

\n75.2<\/p>\n<\/td>\n<\/tr>\n

\n

\nHR (95%<\/p>\n<\/td>\n

\n

\n0.72<\/p>\n<\/td>\n

\n

\n0.84<\/p>\n<\/td>\n

\n

\n0.75<\/p>\n<\/td>\n<\/tr>\n

\n

\nCI)<\/p>\n<\/td>\n

\n

\n(0.37-1.43)<\/p>\n<\/td>\n

\n

\n(0.66-1.07)<\/p>\n<\/td>\n

\n

\n(0.59-0.93)<\/p>\n<\/td>\n<\/tr>\n

\n

i<\/sup> Data cut-off: April 29, 2024<\/p>\n<\/td>\n<\/tr>\n

\n

ii <\/sup>Nominal p-value<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

Summary of additional secondary endpoint outcomes (ITT): NIAGARA<\/b><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

\n\u00a0<\/p>\n<\/td>\n

\n

IMFINZI-based regimen
\n
<\/b>(n=533)<\/b><\/p>\n<\/td>\n

\n

Neoadjuvant chemotherapy
\n
<\/b>(n=530)<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

MFS<\/b>i<\/sup><\/p>\n<\/td>\n<\/tr>\n

\n

\nMFS rate, 24 months (%)<\/p>\n<\/td>\n

\n

\n75.1<\/p>\n<\/td>\n

\n

\n65.1<\/p>\n<\/td>\n<\/tr>\n

\n

\nNumber of MFS events<\/p>\n<\/td>\n

\n

\n152<\/p>\n<\/td>\n

\n

\n201<\/p>\n<\/td>\n<\/tr>\n

\n

\n(%)<\/p>\n<\/td>\n

\n

\n(28.5)<\/p>\n<\/td>\n

\n

\n(37.9)<\/p>\n<\/td>\n<\/tr>\n

\n

\nMedian MFS (95% CI) (in<\/p>\n<\/td>\n

\n

\nNRii<\/sup><\/p>\n<\/td>\n

\n

\nNRii<\/sup><\/p>\n<\/td>\n<\/tr>\n

\n

\nmonths)<\/p>\n<\/td>\n

\n

\n(NRii<\/sup>-NRii<\/sup>)<\/p>\n<\/td>\n

\n

\n(48.0-NRii<\/sup>)<\/p>\n<\/td>\n<\/tr>\n

\n

\nHR (95% CI)<\/p>\n<\/td>\n

\n

\n0.67
\n
(0.54-0.83)<\/p>\n<\/td>\n<\/tr>\n

\n

DSS<\/b>i<\/sup><\/p>\n<\/td>\n<\/tr>\n

\n

\nDSS rate, 24 months (%)<\/p>\n<\/td>\n

\n

\n89.2<\/p>\n<\/td>\n

\n

\n82.2<\/p>\n<\/td>\n<\/tr>\n

\n

\nNumber of deaths due to<\/p>\n<\/td>\n

\n

\n85<\/p>\n<\/td>\n

\n

\n114<\/p>\n<\/td>\n<\/tr>\n

\n

\nbladder cancer (%)<\/p>\n<\/td>\n

\n

\n(15.9)<\/p>\n<\/td>\n

\n

\n(21.5)<\/p>\n<\/td>\n<\/tr>\n

\n

\nMedian DSS (95% CI) (in<\/p>\n<\/td>\n

\n

\nNRii<\/sup><\/p>\n<\/td>\n

\n

\nNRii<\/sup><\/p>\n<\/td>\n<\/tr>\n

\n

\nmonths)<\/p>\n<\/td>\n

\n

\n(NRii<\/sup>-NRii<\/sup>)<\/p>\n<\/td>\n

\n

\n(NRii<\/sup>-NRii<\/sup>)<\/p>\n<\/td>\n<\/tr>\n

\n

\nHR (95% CI)<\/p>\n<\/td>\n

\n

\n0.69
\n
(0.52-0.91)<\/p>\n<\/td>\n<\/tr>\n

\n

i<\/sup> Data cut-off: April 29, 2024<\/p>\n<\/td>\n<\/tr>\n

\n

ii <\/sup>NR, not reached<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\nIMFINZI was generally well tolerated, and no new safety signals were observed in the neoadjuvant and adjuvant settings. Further, adding IMFINZIto neoadjuvant chemotherapy was consistent with the known profile for this combination and did not compromise patients\u2019 ability to complete surgery compared to neoadjuvant chemotherapy alone. Immune-mediated adverse events (imAEs) were consistent with the known profile of IMFINZI, manageable and mostly low-grade.<\/p>\n

\nPerioperative IMFINZI in combination with neoadjuvant chemotherapy was granted Priority Review<\/a> in the US in December 2024 for the treatment of patients with MIBC.Regulatory applications are also currently under review in the European Union (EU), Japan and several other countries based on the NIAGARA trial.<\/p>\n

IMPORTANT SAFETY INFORMATION<\/b><\/p>\n

\nThere are no contraindications for IMFINZI\u00ae<\/sup> (durvalumab) or IMJUDO\u00ae<\/sup> (tremelimumab-actl).<\/p>\n

Severe and Fatal Immune-Mediated Adverse Reactions
\n
<\/b>Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg\/kg\/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.<\/p>\n

Immune-Mediated Pneumonitis
\n
<\/span><\/b>IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation.<\/p>\n