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HONG KONG - China’s National Medical (TASE:BLWV) Products Administration (NMPA) has approved the combination of ORPATHYS (savolitinib) and TAGRISSO (osimertinib) for treating patients with locally advanced or metastatic EGFR mutation-positive non-squamous non-small cell lung cancer (NSCLC) with MET amplification after disease progression on EGFR tyrosine kinase inhibitor therapy, HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) announced Monday.
The approval was based on results from the Phase III SACHI trial, which demonstrated that the combination reduced the risk of disease progression by 66% compared to platinum-based chemotherapy. The median progression-free survival was 8.2 months for the combination versus 4.5 months for chemotherapy, as assessed by investigators.
ORPATHYS is an oral MET tyrosine kinase inhibitor, while TAGRISSO is a third-generation EGFR inhibitor. The combination represents the first all-oral treatment option for these patients.
The safety profile was reported as tolerable with no new safety signals observed. Treatment-emergent adverse events of Grade 3 or above occurred in 57% of patients in both the combination and chemotherapy groups.
This marks the third indication for ORPATHYS in China, where it was first approved as a selective MET inhibitor for NSCLC patients with MET exon 14 skipping alteration. The new approval triggers an $11 million milestone payment to HUTCHMED from AstraZeneca (NASDAQ:AZN), which markets both medications in China.
MET amplification occurs in approximately 15-50% of patients who experience disease progression following treatment with a third-generation EGFR TKI, according to the press release statement.
The SACHI trial results were presented at the American Society of Clinical Oncology Annual Meeting in June 2025. The NMPA had previously designated the combination as a Breakthrough Therapy and granted Priority Review status.
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