HUTCHMED (China) Limited has released top-line data from the global Phase III SAFFRON trial showing that the combination of ORPATHYS® (savolitinib) with TAGRISSO® (osimertinib) achieved statistically significant and clinically meaningful improvements in both progression-free survival (PFS) and overall survival (OS) versus doublet platinum-based chemotherapy in patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) exhibiting high MET overexpression or amplification after disease progression on TAGRISSO®.
Key highlights • First global Phase III study to demonstrate a survival benefit in this patient population, addressing a major resistance mechanism seen in roughly one-third of EGFRm NSCLC cases treated with third-generation EGFR-tyrosine kinase inhibitors (TKIs). • SAFFRON enrolled 338 patients across 230 centers in 29 countries; participants received either ORPATHYS® 300 mg twice daily plus TAGRISSO® 80 mg once daily or standard doublet platinum chemotherapy. The primary endpoint was PFS, with key secondary endpoints including OS and objective response rate. • Safety findings for the combination were consistent with the known profiles of each agent and revealed no new safety concerns. • Results corroborate earlier positive data from the China-based SACHI Phase III trial and the global SAVANNAH Phase II study, reinforcing TAGRISSO®’s role as a foundational therapy and highlighting the benefit of adding the selective MET inhibitor ORPATHYS® to counter MET-mediated resistance.
Regulatory and commercial context ORPATHYS® in combination with TAGRISSO® is already approved in China for EGFRm NSCLC patients with MET amplification following EGFR-TKI progression; it also holds temporary authorization in Switzerland for high-MET patients post-TAGRISSO® therapy. The latest global data will be presented at an upcoming medical forum and submitted to regulatory agencies worldwide, potentially paving the way for broader approvals.
Market backdrop Lung cancer remains the leading cause of cancer mortality, with non-small cell variants representing up to 85 % of cases. EGFR mutations occur in roughly 10-15 % of Western and 30-40 % of Asian NSCLC patients, and approximately 34 % of tumors develop high MET overexpression or amplification after third-generation EGFR-TKI treatment, underscoring the clinical need addressed by the ORPATHYS®-TAGRISSO® regimen.
Corporate notes ORPATHYS® is jointly developed by HUTCHMED and AstraZeneca and is commercialized by AstraZeneca. HUTCHMED, an innovative biopharmaceutical company listed in Hong Kong, London (AIM), and on Nasdaq, now has three marketed medicines in China and one with global approvals.
Further details from the SAFFRON study and timelines for regulatory submissions will be disclosed at forthcoming scientific meetings.