HUTCHMED (00013) announced the completion of patient enrollment for the SAFFRON study, a global Phase III trial evaluating the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutations and MET overexpression and/or amplification, following disease progression on prior TAGRISSO® therapy. The final patient was enrolled on October 31, 2025.

This all-oral, chemotherapy-free combination therapy offers a promising treatment option for patients who progressed after EGFR tyrosine kinase inhibitor (TKI) therapy. It was approved in China in June 2025 based on results from the SACHI Phase III study.

ORPATHYS®, a potent and highly selective oral MET TKI, was co-developed by AstraZeneca and HUTCHMED and is commercialized by AstraZeneca. TAGRISSO® is an irreversible third-generation EGFR TKI.

The SAFFRON study is an open-label, randomized, global multicenter Phase III trial comparing ORPATHYS® plus TAGRISSO® versus platinum-based doublet chemotherapy in EGFR-mutated, MET-overexpressed/amplified NSCLC patients who progressed after first- or second-line TAGRISSO® therapy. The primary endpoint is progression-free survival (PFS) assessed by blinded independent central review (BICR) per RECIST 1.1 criteria. Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), time to response (TTR), and safety.

A total of 338 patients were randomized across over 230 sites in 29 countries. Topline results are expected in the first half of 2026, with subsequent submissions to academic conferences. Positive data may support global regulatory filings for the ORPATHYS® and TAGRISSO® combination.