Hutchmed Reports Positive Phase III SANOVO Trial Results in Lung Cancer
核心洞察
HUTCHMED reported positive high-level results from the Phase III SANOVO trial of ORPATHYS (savolitinib) plus TAGRISSO (osimertinib) in treatment-naive advanced non-small cell lung cancer (搜索).
The all-oral combination met its primary endpoint with statistically significant and clinically meaningful progression-free survival improvement versus TAGRISSO alone in both the high MET and intention-to-treat populations.
Overall survival, a secondary endpoint, showed encouraging benefit in both groups, with full data scheduled for presentation at a forthcoming medical meeting.
HUTCHMED (China) Limited (搜索) has reported positive high-level results from the Phase III SANOVO trial, which evaluated ORPATHYS (savolitinib) plus TAGRISSO (osimertinib) in treatment-naive patients with locally advanced or metastatic non-small cell lung cancer (搜索) (NSCLC) harboring EGFR (搜索) mutations and MET overexpression. The combination produced a statistically significant and clinically meaningful improvement in progression-free survival versus TAGRISSO alone, with benefit seen in both the high MET population and the intention-to-treat population. Overall survival, a secondary endpoint, also showed encouraging clinical benefit in both groups, and follow-up continues with data slated for a forthcoming medical meeting.
SANOVO is a blinded, randomized, controlled Phase III study conducted in China. A total of 326 treatment-naive patients were randomized 1:1 to TAGRISSO 80 mg once daily plus either ORPATHYS or placebo at 300/200 mg twice daily, dosed by body weight. The primary endpoint was investigator-assessed PFS; other endpoints included PFS by independent review committee, overall survival, objective response rate, duration of response, disease control rate, time to response and safety. The safety profile of the combination was consistent with the known profiles of each individual medicine, with no new safety findings reported.
The results build on existing pipeline validation. ORPATHYS plus TAGRISSO is already approved in China for patients with EGFR (搜索)-mutated NSCLC and MET amplification after progression on EGFR-TKI therapy, based on the SACHI Phase III trial, and the global SAFFRON Phase III trial reported positive high-level results in August 2026 showing improvements in both PFS and OS in similar patients who progressed on TAGRISSO. The SANOVO principal investigator noted that co-occurring MET overexpression often compromises the durability of EGFR-TKI monotherapy, and that addressing both pathways upfront offers a new approach for this patient population.
Source: ScanX