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HUTCHMED Completes Patient Enrollment of SANOVO Phase III Trial of ORPATHYS® and TAGRISSO® Combination as a First-Line Therapy for Certain Lung Cancer Patients in China
GlobeNewswire· 2025-08-20 00:00
Core Insights - HUTCHMED has completed patient enrollment for the SANOVO Phase III study, evaluating the combination of ORPATHYS and TAGRISSO in treating non-small cell lung cancer (NSCLC) patients with specific genetic mutations [1][2][3] Group 1: Study Details - The SANOVO trial is a randomized, controlled study focusing on previously untreated patients with locally advanced or metastatic NSCLC, specifically those with activating EGFR mutations and MET overexpression [2] - The primary endpoint of the study is progression-free survival (PFS), with additional endpoints including overall survival (OS), objective response rate (ORR), and safety assessments [2] - Topline results from the SANOVO study are expected in the second half of 2026, which may lead to a supplementary New Drug Application submission to China's National Medical Products Administration (NMPA) if results are favorable [3] Group 2: Drug Information - ORPATHYS (savolitinib) is a selective MET tyrosine kinase inhibitor developed by AstraZeneca and HUTCHMED, while TAGRISSO (osimertinib) is a third-generation EGFR TKI [4][10] - ORPATHYS is already approved in China for specific NSCLC indications, including treatment for patients with MET exon 14 skipping alterations and in combination with TAGRISSO for EGFRm-positive NSCLC [8] - TAGRISSO has been used to treat over one million patients globally and has shown improved outcomes in various stages of NSCLC [10][11] Group 3: Market Context - Lung cancer is the leading cause of cancer death, with NSCLC accounting for 80-85% of cases, and a significant portion of patients diagnosed with advanced disease [5] - Approximately 10-15% of NSCLC patients in the US and Europe, and up to 40-50% in Asia, have EGFR-mutated NSCLC, highlighting a substantial market for targeted therapies [5][6] - The combination of ORPATHYS and TAGRISSO aims to address resistance mechanisms in advanced NSCLC, representing a promising treatment strategy [15][14]