HUTCHMED and AstraZeneca report positive Phase III SAFFRON data in EGFR-mutated lung cancer

HUTCHMED announced on August 17, 2026 that the Phase III SAFFRON trial met its goals. Positive high-level results from the SAFFRON Phase III trial showed ORPATHYS (savolitinib) plus TAGRISSO (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival and overall survival versus doublet platinum-based chemotherapy in patients with EGFR-mutated non-small cell lung cancer, the company said.¹ Patients enrolled had tumors with high levels of MET overexpression or amplification and had progressed on prior treatment with TAGRISSO.¹

The trial addresses a known resistance pattern. An estimated 34% of tumors will develop high levels of MET overexpression or amplification after progression on a third-generation EGFR TKI.¹

SAFFRON's design specifics: it is a randomized, open-label, multi-center, global Phase III trial studying ORPATHYS (300mg twice daily) added to TAGRISSO (80mg once daily) versus doublet platinum-based chemotherapy in 338 patients with EGFR-mutated, locally advanced or metastatic NSCLC with MET overexpression or amplification whose disease progressed following first- or second-line treatment with TAGRISSO.¹ The trial enrolled patients in 230 centers across 29 countries, including North America, Europe, South America and Asia, with PFS as the primary endpoint and OS and objective response rate as key secondary endpoints.¹

On safety, the safety profile for ORPATHYS plus TAGRISSO was consistent with the known profiles of each medicine, and there were no new safety findings.¹ The company said full data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.¹ The combination is already approved in China for patients with locally advanced or metastatic EGFR-mutated NSCLC with MET amplification after disease progression on EGFR-TKI therapy, based on the earlier SACHI Phase III trial.¹