HUTCHMED (00013) announced that the SANOVO study of the combination therapy of ORPATHYS and TAGRISSO showed significant progression-free survival benefits in first-line patients with MET-overexpressing EGFR mutant lung cancer in China.

HUTCHMED (00013) announced that the SANOVO Phase III study conducted in China in patients with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations and MET overexpression has achieved positive topline results. The combination therapy of ORPATHYS (savolitinib) and TAGRISSO (osimertinib) demonstrated statistically significant and highly clinically meaningful improvements in progression-free survival (PFS) compared to TAGRISSO monotherapy in populations with high-level MET and the intent-to-treat group. In both patient populations, the combination therapy also showed encouraging clinical benefits in overall survival (OS), one of the secondary endpoints of the study. The research will continue to follow up on these results. The aforementioned data will be presented at an upcoming academic conference. Professor Wu Yilong, the principal investigator of the SANOVO study from Guangdong Provincial People's Hospital, stated: In previously untreated NSCLC patients with EGFR mutations, the concurrent occurrence of MET overexpression often undermines the long-term efficacy of EGFR tyrosine kinase inhibitor monotherapy. The positive results from the SANOVO study indicate that early intervention on these two pathways through this fully oral, biomarker-driven treatment regimen provides a powerful new treatment option for patients with MET overexpression associated with such tumors. By combining ORPATHYS and TAGRISSO, we observed clear clinical benefits that have the potential to reshape the first-line treatment strategy for this specific patient population. Dr. Su Weiguo, CEO and Chief Scientific Officer of HUTCHMED, expressed: We are pleased that the SANOVO study has achieved positive results, validating our strategy to address MET-driven disease across multiple stages of lung cancer. Building on the solid foundation established by the earlier SAFFRON global Phase III study and the SACHI China Phase III study in treated patients, the SANOVO data further confirm the therapeutic strength and broad applicability of the combination therapy of ORPATHYS and TAGRISSO in first-line patients. We sincerely thank all the patients and researchers involved in this study and look forward to sharing these data with regulatory authorities to bring this innovative, fully oral combination regimen into first-line treatment as soon as possible. Dr. He Jing, head of global R&D in China at AstraZeneca, stated: These positive data highlight that during the initial treatment phase, ORPATHYS plays a key role by intercepting MET-driven resistance. By combining ORPATHYSs precise targeting advantage with TAGRISSOs foundational role, the SANOVO study has brought meaningful clinical progress to previously untreated patients with MET overexpression and EGFR mutations. We are very much looking forward to collaborating with HUTCHMED to position ORPATHYS as a transformative, biomarker-driven new treatment option in the first-line treatment of lung cancer in China. The safety profile of the combination therapy of ORPATHYS and TAGRISSO is consistent with the known safety of each drug, and no new safety issues have been identified. Based on the SACHI Phase III study, the combination therapy of ORPATHYS and TAGRISSO has been approved in China for the treatment of patients with locally advanced or metastatic NSCLC with EGFR mutations and MET amplification who have experienced disease progression after treatment with EGFR tyrosine kinase inhibitors (TKI). The SAFFRON global Phase III study, which investigates this combination therapy for patients with EGFR mutation non-small cell lung cancer who experience disease progression after treatment with TAGRISSO and have MET overexpression or amplification, also reported positive topline data in August 2026, showing statistically and clinically meaningful improvements in PFS and overall survival (OS). ORPATHYS is jointly developed by AstraZeneca and HUTCHMED and is commercialized by AstraZeneca.