{"id":1013291,"date":"2026-10-25T11:33:06","date_gmt":"2026-10-25T15:33:06","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/tagrisso-osimertinib-plus-savolitinib-reduced-the-risk-of-disease-progression-or-death-by-45-and-the-risk-of-death-by-32-in-met-driven-egfr-mutated-lung-cancer-after-progression-on-tagrisso\/"},"modified":"2026-10-25T11:33:06","modified_gmt":"2026-10-25T15:33:06","slug":"tagrisso-osimertinib-plus-savolitinib-reduced-the-risk-of-disease-progression-or-death-by-45-and-the-risk-of-death-by-32-in-met-driven-egfr-mutated-lung-cancer-after-progression-on-tagrisso","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/tagrisso-osimertinib-plus-savolitinib-reduced-the-risk-of-disease-progression-or-death-by-45-and-the-risk-of-death-by-32-in-met-driven-egfr-mutated-lung-cancer-after-progression-on-tagrisso\/","title":{"rendered":"TAGRISSO\u00ae (osimertinib) plus savolitinib reduced the risk of disease progression or death by 45% and the risk of death by 32% in MET-driven EGFR-mutated lung cancer after progression on TAGRISSO"},"content":{"rendered":"

<\/p>\n

TAGRISSO\u00ae (osimertinib) plus savolitinib reduced the risk of disease progression or death by 45% and the risk of death by 32% in MET-driven EGFR<\/i>-mutated lung cancer after progression on TAGRISSO<\/b><\/p>\n

TAGRISSO plus savolitinib extended median overall survival by nearly five months<\/i><\/b><\/p>\n

SAFFRON is first global Phase III trial to show significant <\/i><\/b>progression-free and overall survival benefit in this setting, <\/i><\/b>reinforcing TAGRISSO as backbone therapy across EGFRm lung cancer<\/i><\/b><\/p>\n

WILMINGTON, Del.–(BUSINESS WIRE<\/a>)–
\nPositive results from the SAFFRON Phase III trial showed TAGRISSO\u00ae<\/sup> (osimertinib) plus savolitinib demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) versus doublet platinum-based chemotherapy in patients with epidermal growth factor receptor-mutated (EGFR<\/i>m) non-small cell lung cancer (NSCLC). Patients in the trial had tumors with high levels of MET overexpression or amplification and had progressed on prior treatment with TAGRISSO.<\/p>\n

\nThese results will be presented today during the Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain (abstract #LBA6).1<\/sup> They were also simultaneously published in The New England Journal of Medicine<\/i><\/a>.<\/p>\n

\nResults showed TAGRISSO plus savolitinib reduced the risk of disease progression or death by 45% compared to chemotherapy (based on a PFS hazard ratio [HR] of 0.55; 95% confidence interval [CI] 0.42-0.72; p<0.001). Median PFS as assessed by blinded independent central review (BICR) was 7.6 months for TAGRISSO plus savolitinib versus 5.4 months for the comparator arm. An estimated 36% of patients treated with the combination were progression-free at one year compared to 10% in the comparator arm. Importantly, the PFS benefit observed was consistent across all prespecified subgroups, including patients whose tumors had MET-overexpression or MET-amplification.<\/p>\n

\nResults for the key secondary endpoint of OS showed TAGRISSO plus savolitinib reduced the risk of death by 32% versus chemotherapy (OS HR 0.68; 95% CI 0.50-0.91; p=0.010). TAGRISSO plus savolitinib extended median OS by 4.9 months versus the comparator arm (17.8 versus 12.9 months). An estimated 70% of patients treated with the combination were alive at one year compared to 53% in the comparator arm.<\/p>\n

\nProfessor Shun Lu, Director of Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine and principal investigator of the trial, said: \u201cThese results have the potential to establish a new global standard of care for the third of patients with EGFR<\/i>-mutated non-small cell lung cancer experiencing high levels of MET-driven resistance after osimertinib. There are currently no well-tolerated, oral, biomarker-directed treatment options to address this frequent driver of disease progression. Osimertinib plus savolitinib significantly extended median overall survival by nearly five months in this later-line setting, establishing a new clinical benchmark and reinforcing the critical need for MET testing to guide patient care.\u201d<\/p>\n

\nSusan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: \u201cThese data show combining savolitinib with backbone therapy TAGRISSO directly addresses MET-driven resistance while maintaining EGFR<\/i> suppression, building on the established efficacy, safety and central nervous system protection of TAGRISSO. With the potential to become the first biomarker-directed, all-oral treatment option in this setting, this combination further strengthens our leadership in EGFR<\/i>-mutated lung cancer and reflects our strategy of matching the right therapy to the underlying drivers of disease at every stage.\u201d<\/p>\n

\nJohnny Cheng, Acting Chief Executive Officer and Chief Financial Officer, HUTCHMED, said: \u201cThese data from SAFFRON mark a decisive step forward in targeting MET-driven resistance\u2014a longstanding challenge in EGFR<\/i>-mutated lung cancer. Precision inhibition with savolitinib alongside TAGRISSO offers a meaningful, all-oral option for patients with disease progression. We are delighted to see that our partnership with AstraZeneca continues to deliver impactful innovations that have the potential to redefine standard of care and improve outcomes for patients globally.\u201d<\/p>\n

Summary of PFS and OS results: SAFFRONi<\/sup><\/b><\/p>\n\n\n\n\n\n\n\n\n\n\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

TAGRISSO +
\n
<\/b>savolitinib<\/b><\/p>\n

(<\/b>n=171)<\/b><\/p>\n<\/td>\n

\n

Chemotherapy<\/b><\/p>\n

(<\/b>n=167)<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

PFS by BICR: Full Analysis Set (FAS)<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\nNumber of patients with event, n (%)<\/p>\n<\/td>\n

\n

\n117 (68.4)<\/p>\n<\/td>\n

\n

\n113 (67.7)<\/p>\n<\/td>\n<\/tr>\n

\n

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

\n

\n7.6 (5.6-9.7)<\/p>\n<\/td>\n

\n

\n5.4 (4.2-5.8)<\/p>\n<\/td>\n<\/tr>\n

\n

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

\n

\n0.55 (0.42-0.72)<\/p>\n<\/td>\n<\/tr>\n

\n

\np-value<\/p>\n<\/td>\n

\n

\np<0.001<\/p>\n<\/td>\n<\/tr>\n

\n

\nPFS rate at 12 months (%)<\/p>\n<\/td>\n

\n

\n36<\/p>\n<\/td>\n

\n

\n10<\/p>\n<\/td>\n<\/tr>\n

\n

OS: FAS<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\nNumber of deaths, n (%)<\/p>\n<\/td>\n

\n

\n87 (50.9)<\/p>\n<\/td>\n

\n

\n93 (55.7)<\/p>\n<\/td>\n<\/tr>\n

\n

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

\n

\n17.8 (15.6-23.7)<\/p>\n<\/td>\n

\n

\n12.9 (10.6-16.8)<\/p>\n<\/td>\n<\/tr>\n

\n

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

\n

\n0.68 (0.50-0.91)<\/p>\n<\/td>\n<\/tr>\n

\n

\np-value<\/p>\n<\/td>\n

\n

\np=0.010<\/p>\n<\/td>\n<\/tr>\n

\n

\nOS rate at 12 months (%)<\/p>\n<\/td>\n

\n

\n70<\/p>\n<\/td>\n

\n

\n53<\/p>\n<\/td>\n<\/tr>\n

\n

PFS by BICR: MET-overexpressed analysis set<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\nNumber of patients, n<\/p>\n<\/td>\n

\n

\n127<\/p>\n<\/td>\n

\n

\n118<\/p>\n<\/td>\n<\/tr>\n

\n

\nNumber of patients with event, n (%)<\/p>\n<\/td>\n

\n

\n77 (60.6)<\/p>\n<\/td>\n

\n

\n80 (67.8)<\/p>\n<\/td>\n<\/tr>\n

\n

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

\n

\n8.5 (5.7-11.1)<\/p>\n<\/td>\n

\n

\n5.6 (4.4-6.7)<\/p>\n<\/td>\n<\/tr>\n

\n

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

\n

\n0.51 (0.37-0.71)<\/p>\n<\/td>\n<\/tr>\n

\n

\np-value<\/p>\n<\/td>\n

\n

\np<0.001<\/p>\n<\/td>\n<\/tr>\n

\n

\nPFS rate at 12 months (%)<\/p>\n<\/td>\n

\n

\n40<\/p>\n<\/td>\n

\n

\n11<\/p>\n<\/td>\n<\/tr>\n

\n

PFS by BICR: MET-amplified analysis setii<\/sup><\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\nNumber of patients, n<\/p>\n<\/td>\n

\n

\n129<\/p>\n<\/td>\n

\n

\n116<\/p>\n<\/td>\n<\/tr>\n

\n

\nNumber of patients with event, n (%)<\/p>\n<\/td>\n

\n

\n89 (68.9)<\/p>\n<\/td>\n

\n

\n79 (68.1)<\/p>\n<\/td>\n<\/tr>\n

\n

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

\n

\n7.64 (5.6-9.7)<\/p>\n<\/td>\n

\n

\n4.2 (3.1-5.5)<\/p>\n<\/td>\n<\/tr>\n

\n

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

\n

\n0.487 (0.35-0.66)<\/p>\n<\/td>\n<\/tr>\n

\n

\nPFS rate at 12 months (%)<\/p>\n<\/td>\n

\n

\n33<\/p>\n<\/td>\n

\n

\n8<\/p>\n<\/td>\n<\/tr>\n

\n

\ni OS and PFS data cut-off was July 6, 2026.<\/p>\n

\nii No formal statistical testing was carried out for the MET-amplified analysis set<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\nThe safety profile for TAGRISSO plus savolitinib was manageable and consistent with the known profiles of each medicine, and there were no new safety concerns. Grade 3 or higher treatment-emergent adverse events from all causes occurred in 64% of patients treated with TAGRISSO plus savolitinib and 63% of patients in the comparator arm. Median total duration of treatment exposure was more than twice as long for TAGRISSO plus savolitinib (8.5 months) compared with the comparator arm (3.5 months).<\/p>\n

\nBased on the SAFFRON Phase III trial results, a New Drug Application (NDA) for TAGRISSO plus savolitinib was submitted to the US Food and Drug Administration for the treatment of patients with locally advanced or metastatic NSCLC whose tumors have MET overexpression or amplification and who had disease progression on or after an EGFR<\/i>-tyrosine kinase inhibitor (TKI) therapy. TAGRISSO plus savolitinib is approved in China for patients with locally advanced or metastatic EGFR<\/i>m-positive non-squamous NSCLC with MET amplification after disease progression on EGFR<\/i>-TKI therapy based on the SACHI Phase III trial.<\/p>\n

\nResults from the SANOVO Phase III trial evaluating TAGRISSO plus savolitinib in treatment-naive patients in China with EGFR<\/i>m locally advanced or metastatic NSCLC and MET overexpression will be presented tomorrow during a Proffered Paper session at the ESMO Congress (abstract #LBA69).2<\/sup><\/p>\n

\nSavolitinibis being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca.<\/p>\n

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