HUTCHMED lung cancer treatment filings advance
Key points
- HUTCHMED announced that European and Japanese regulators have accepted applications for the ORPATHYS and TAGRISSO combination to treat certain patients with advanced lung cancer.
- The SAFFRON Phase III trial showed median progression-free survival of 7.6 months versus 5.4 months and overall survival of 17.8 months versus 12.9 months.
- The European and Japanese applications remain under review, following a separate US regulatory submission in September 2026.
HUTCHMED (NASDAQ:HCM) announced that regulatory applications for ORPATHYS combined with TAGRISSO have been accepted for review in Europe and Japan for certain patients with advanced lung cancer.
The applications cover patients with MET overexpression or amplification whose disease progressed after previous EGFR-targeted therapy, extending the regulatory process beyond the US application submitted in September 2026.
The SAFFRON trial compared the combination with platinum-based chemotherapy and reported median progression-free survival of 7.6 months versus 5.4 months, while median overall survival reached 17.8 months versus 12.9 months, with both improvements reported as statistically significant.
HUTCHMED said no new safety concerns emerged during the trial, while the European and Japanese regulatory applications remain under review and no approval decision has been announced.
The treatment combines savolitinib, marketed as ORPATHYS, with osimertinib, marketed as TAGRISSO, and targets patients whose lung cancer has progressed following EGFR-targeted treatment and who have MET-related tumour changes.
HUTCHMED develops and commercialises medicines for cancer and immunological diseases, while AstraZeneca is responsible for submitting the regulatory applications for the combination in the relevant markets.
