Business Wire

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

Business Wire

TAGRISSO plus savolitinib extended median overall survival by nearly five months

SAFFRON is first global Phase III trial to show significant progression-free and overall survival benefit in this setting, reinforcing TAGRISSO as backbone therapy across EGFRm lung cancer

WILMINGTON, Del., October 25, 2026--Positive results from the SAFFRON Phase III trial showed TAGRISSO® (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 (EGFRm) 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.

These 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 They were also simultaneously published in The New England Journal of Medicine.

Results 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.

Results 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.

Professor 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: "These results have the potential to establish a new global standard of care for the third of patients with EGFR-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."