Biopharmaceutical company HUTCHMED (China) Limited (Nasdaq/AIM: HCM) (HKEX: 13) announced on Wednesday that it has completed patient enrollment for its global Phase III SAFFRON trial evaluating ORPATHYS (savolitinib) in combination with TAGRISSO (osimertinib) in patients with epidermal growth factor receptor (EGFR)-mutated, MET-overexpressed and/or amplified, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on prior TAGRISSO therapy. The final patient was randomised on 31 October 2025.

SAFFRON is a randomised, open-label, multicentre study comparing the ORPATHYS and TAGRISSO combination against platinum-based doublet chemotherapy. The trial enrolled 338 patients across more than 230 sites in 29 countries. Primary analysis will assess progression-free survival by blinded independent central review, with additional endpoints including overall survival, objective response rate, duration of response, and safety. Topline data are expected in the first half of 2026, with potential for subsequent global regulatory submissions.

The combination was approved in China in June 2025 following positive results from the SACHI Phase III trial. ORPATHYS, developed jointly by AstraZeneca and HUTCHMED, is a highly selective MET inhibitor, while TAGRISSO is AstraZeneca's third-generation EGFR tyrosine kinase inhibitor (TKI). Together, they offer a chemotherapy-free, oral treatment option targeting mechanisms of resistance in EGFR-mutated NSCLC.

HUTCHMED continues to advance multiple late-stage trials of ORPATHYS and TAGRISSO, including the SANOVO and SACHI studies in China, aiming to expand treatment options for patients with MET-driven NSCLC globally.