HUTCHMED 338-patient trial improves survival outcomes

• HUTCHMED said ORPATHYS plus TAGRISSO significantly improved progression-free and overall survival versus platinum-based chemotherapy in the Phase 3 SAFFRON trial.
• HUTCHMED shares were up about 0.4% at $12.20 in pre-market trading following the announcement.
• HUTCHMED said it will present the data at a medical meeting and share the findings with global regulators to support potential registrations.

HUTCHMED (NASDAQ:HCM) reported that ORPATHYS plus TAGRISSO significantly improved progression-free and overall survival versus platinum-based chemotherapy in its 338-patient Phase 3 SAFFRON trial.

The global study enrolled patients with EGFR-mutated advanced non-small cell lung cancer and high MET overexpression or amplification after their disease progressed on TAGRISSO.

SAFFRON enrolled 338 patients at more than 230 sites across 29 countries, with progression-free survival as the primary endpoint and overall survival among its key secondary endpoints.

HUTCHMED said the findings will be shared with global regulators to support potential registrations, while no new safety findings were identified.

Following the announcement, HUTCHMED's share price was up 0.4% at $12.20 in pre-market trading.

ORPATHYS plus TAGRISSO is already approved in China for certain EGFR-mutated advanced NSCLC patients with MET amplification following progression on EGFR TKI treatment.

HUTCHMED and AstraZeneca (NYSE:AZN) jointly develop ORPATHYS, while AstraZeneca commercializes the medicine and the combination also has temporary authorization in Switzerland for certain patients.