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A phase 3 trial just rewrote the playbook for a tough-to-treat lung cancer. The SAFFRON trial showed that combining osimertinib with savolitinib significantly outperformed standard chemotherapy in patients with EGFR-mutated NSCLC whose tumors developed MET-driven resistance after osimertinib. The combo cut the risk of disease progression by 45% and death by 32%, prompting experts to call it the new global standard of care — and an FDA application is already in.
The phase 3 SAFFRON trial has established osimertinib (Tagrisso) plus savolitinib (Orpathys) as the new global standard of care for patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC) whose tumors developed MET overexpression and/or amplification after progressing on osimertinib. Presented at the 2026 ESMO Congress and simultaneously published in the New England Journal of Medicine, the results mark a major shift in how oncologists will manage this common resistance mechanism.
The all-oral combination beat platinum/pemetrexed chemotherapy on every key measure — survival, response, and tolerability. Notably, the PFS benefit held up even in patients with brain metastases, a notoriously difficult subgroup to treat.
By the Numbers:
Why it matters: MET overexpression/amplification affects roughly 34% of patients after third-generation EGFR TKI failure — a large population with limited options. With an FDA NDA already submitted in September 2026, this combo could soon offer a chemotherapy-free, oral alternative with a more favorable safety profile for these patients.
