ORPATHYS (savolitinib) + TAGRISSO (osimertinib) - (SAFFRON)

August 17, 2026: AstraZeneca (NYSE: AZN) reported positive high-level results from the global Phase III SAFFRON trial of TAGRISSO (osimertinib) plus savolitinib in EGFR-mutated, locally advanced or metastatic NSCLC with high MET overexpression or amplification after progression on prior TAGRISSO. The combination showed a statistically significant and clinically meaningful improvement in both progression-free survival and overall survival versus doublet platinum-based chemotherapy, with no new safety findings and a safety profile consistent with the known profiles of each drug.

SAFFRON enrolled 338 patients across 230 centers in 29 countries; the primary endpoint is PFS, with OS and objective response rate as key secondary endpoints. AstraZeneca and HUTCHMED said the data support potential global regulatory filings for the TAGRISSO/savolitinib combination. The results are planned for presentation at a forthcoming medical meeting and will be shared with global regulatory authorities.

The release also notes that TAGRISSO plus savolitinib is already approved in China based on the Phase III SACHI trial, and has temporary authorization in Switzerland based on the Phase II SAVANNAH trial.