HUTCHMED (00013): Announced SAFFRON global Phase III study data at the 2026 European Society for Medical Oncology (ESMO) Congress and simultaneously published in The New England Journal of Medicine

HUTCHMED (00013) announced that HUTCHMED (China) Limited (referred to as HUTCHMED or HUTCHMED) today announced positive results from the SAFFRON global Phase III study. In patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer, the combination therapy of ORPATHYS (savolitinib) and TAGRISSO (osimertinib) demonstrated statistically and clinically significant improvements in progression-free survival (PFS) and overall survival (OS) compared with platinum-based doublet chemotherapy. Patients in the study had tumors harboring high-level MET overexpression or amplification and had experienced disease progression after prior treatment with TAGRISSO. The above results were presented at the Presidential Symposium session of the 2026 European Society for Medical Oncology (ESMO) Congress held in Madrid, Spain (abstract number #LBA6), and simultaneously published in The New England Journal of Medicine. The high-profile presentation at the premier academic gathering in oncology and flagship medical journal underscores the pivotal role of the SAFFRON study in reshaping the treatment landscape for MET-driven EGFR-mutated non-small cell lung cancer. The data confirm that ORPATHYS combined with TAGRISSO provides a milestone all-oral treatment option to address the major unmet clinical need of MET-driven resistance following third-generation EGFR tyrosine kinase inhibitor (TKI) therapy. Study results showed that the combination therapy of ORPATHYS and TAGRISSO reduced the risk of disease progression or death by 45% compared with chemotherapy (based on PFS hazard ratio [HR] 0.55; 95% confidence interval [CI] 0.42-0.72; p<0.001). Median PFS as assessed by blinded independent central review (BICR) was 7.6 months in the ORPATHYS and TAGRISSO combination group versus 5.4 months in the control group. An estimated 36% of patients in the combination group had no disease progression at 1 year, compared with 10% in the control group. Notably, consistent PFS benefit was observed across all prespecified subgroups, including patients with MET overexpression and MET amplification. Results for the key secondary endpoint OS showed that the combination therapy of ORPATHYS and TAGRISSO reduced the risk of death by 32% compared with chemotherapy (OS HR 0.68; 95% CI 0.50-0.91; p=0.010). The ORPATHYS and TAGRISSO combination group extended median OS by 4.9 months (17.8 months vs. 12.9 months). An estimated 70% of patients in the combination group were still alive at 1 year, compared with 53% in the control group. Professor Shun Lu, the study's global principal investigator, from Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University School of Medicine and Director of the Shanghai Lung Cancer Center, said: "These results are expected to establish a new global treatment standard for approximately one-third of patients with EGFR-mutated non-small cell lung cancer who develop MET-driven resistance after osimertinib treatment. For this common driver of disease progression, there is currently no well-tolerated, biomarker-guided oral treatment option. In this later-line treatment setting, savolitinib combined with osimertinib significantly extended median overall survival by nearly 5 months, with the potential to set a new clinical benchmark and highlighting the urgent need for MET testing to guide patient treatment." Mr. Weiguo Su, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, said: "The data from the SAFFRON study mark a decisive step forward in addressing MET-driven resistance, which has long been a major challenge in EGFR-mutated lung cancer. ORPATHYS combined with TAGRISSO delivers precision inhibition, providing a highly meaningful all-oral treatment option for patients with disease progression. We are pleased to see our collaboration with AstraZeneca continue to deliver impactful innovations that reshape treatment standards and improve outcomes for patients worldwide." Dr. Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "These data demonstrate that combining ORPATHYS with the cornerstone therapy TAGRISSO can directly address MET-driven resistance mechanisms while continuing to inhibit EGFR, building on the established efficacy, safety, and central nervous system protection of TAGRISSO. This combination has the potential to become the first biomarker-guided all-oral treatment option in this therapeutic area, further consolidating our leadership in EGFR-mutated lung cancer and reflecting our strategy of matching the appropriate therapy to the underlying driver at every stage of the disease."