HUTCHMED advances ORPATHYS lung cancer application

• HUTCHMED announced AstraZeneca submitted a U.S. application for ORPATHYS plus TAGRISSO in MET-driven EGFR-mutated lung cancer.
• The application is based on Phase III SAFFRON trial results showing improved progression-free and overall survival versus chemotherapy.
• U.S. approval remains pending, with the combination evaluated after disease progression on EGFR-targeted therapy.

HUTCHMED (NASDAQ:HCM) announced that AstraZeneca (NASDAQ:AZN) submitted a U.S. regulatory application for ORPATHYS in combination with TAGRISSO for patients with MET-driven EGFR-mutated non-small cell lung cancer.

The application seeks approval for patients with locally advanced or metastatic disease whose tumors show MET overexpression or amplification and whose cancer progressed after EGFR-targeted therapy.

HUTCHMED said the application is supported by results from the 338-patient Phase III SAFFRON trial, where the combination improved progression-free survival and overall survival compared with doublet platinum-based chemotherapy in patients whose disease progressed on TAGRISSO.

The company said both survival improvements in the SAFFRON trial were statistically significant, while the safety profile was consistent with the known safety profiles of ORPATHYS and TAGRISSO.

U.S. approval for the combination remains pending regulatory review.