HUTCHMED's stock surged 5.99% in the pre-market session on Thursday, following the announcement that the company's New Drug Application (NDA) for the combination of ORPATHYS® and TAGRISSO® in lung cancer patients with MET amplification after progression on first-line EGFR inhibitor therapy has been accepted and granted priority review status by the China National Medical Products Administration (NMPA).
The NDA submission was supported by data from the SACHI Phase III trial, which evaluated the efficacy and safety of the ORPATHYS® and TAGRISSO® combination compared to standard chemotherapy. The study met its primary endpoint of progression-free survival in a planned interim analysis, leading to the early conclusion of enrollment.
According to Dr. Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED, the combination has demonstrated clear evidence to address MET-driven EGFR-inhibitor resistance and offers a continued path for oral treatment. The company hopes to bring this all-oral, chemotherapy-free treatment option to patients with MET-driven lung cancer in the near future.
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