HUTCHMED (00013.HK): ORPATHYS® + TAGRISSO® combination shows statistically and clinically meaningful PFS and OS improvement in MET-driven EGFR-mutated lung cancer

NewTimeSpace News: On 17 August 2026, HUTCHMED (China) Limited (stock code: 00013) announced positive topline results from the SAFFRON Phase III study of ORPATHYS® (savolitinib) in combination with TAGRISSO® (osimertinib) in patients with EGFR-mutated non-small cell lung cancer (NSCLC), demonstrating statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS) versus platinum-based doublet chemotherapy. The study enrolled patients whose tumors had high levels of MET overexpression or amplification and who had progressed on prior TAGRISSO®. This is the first global Phase III trial in this disease setting to demonstrate significant benefit on both PFS and OS.

According to the announcement, SAFFRON is an open-label, randomized, multi-center global Phase III study evaluating ORPATHYS® (300 mg twice daily) in combination with TAGRISSO® (80 mg once daily) versus platinum-based doublet chemotherapy in 338 patients with locally advanced or metastatic EGFR-mutated NSCLC with MET overexpression or amplification who progressed on first- or second-line TAGRISSO®. The study enrolled patients across more than 230 study centers in 29 countries in North America, Europe, South America and Asia. The primary endpoint is PFS, with key secondary endpoints including OS and objective response rate (ORR). The safety profile of the combination was consistent with the known safety profiles of each medicine, with no new safety concerns identified. The data will be presented at an upcoming medical conference and shared with global regulatory authorities.

In terms of background, third-generation EGFR tyrosine kinase inhibitors (TKIs) have significantly improved outcomes for patients with EGFR-mutated NSCLC. However, approximately one-third of patients develop MET overexpression or amplification, one of the most common mechanisms of resistance to third-generation EGFR TKIs, and MET-driven resistance is often associated with poor prognosis. An estimated 34% of tumors develop high-level MET overexpression or amplification after treatment with third-generation EGFR TKIs. Professor Shun Lu, Principal Investigator of the study and Director of Shanghai Lung Cancer Clinical Medical Center at Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, stated that the SAFFRON data not only reflect the potential impact of this innovative combination of osimertinib and savolitinib, but also underscore the urgency of early MET testing to guide treatment decisions.

Dr. Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, stated that following the SACHI Phase III study which supported approval of the combination in China, the SAFFRON global study results further validate its efficacy and will provide clear data support for global registration of the TAGRISSO® and ORPATHYS® combination. Based on the SACHI Phase III study, the combination has been approved in China for the treatment of patients with locally advanced or metastatic EGFR-mutated NSCLC with MET amplification who have progressed after EGFR TKI therapy; based on results from the SAVANNAH global Phase II study, the combination has also received temporary authorization in Switzerland. ORPATHYS® was developed jointly by AstraZeneca and HUTCHMED and is commercialized by AstraZeneca. It has been approved in China for the treatment of adult patients with locally advanced or metastatic NSCLC harboring MET exon 14 skipping alterations, making it the first selective MET inhibitor approved in China. 

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