HUTCHMED (00013) Announces SANOVO Phase III Study Data of ORPATHYS Combined with TAGRISSO for First-Line Treatment of EGFR-Mutated Lung Cancer at the 2026 European Society for Medical Oncology (ESMO) Congress

HUTCHMED (00013) announced positive results from the SANOVO China Phase III study. In treatment-nave patients with locally advanced or metastatic non-small cell lung cancer harboring epidermal growth factor receptor ("EGFR") mutations and MET overexpression, the combination of ORPATHYS (savolitinib) and TAGRISSO (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in the primary endpoint of progression-free survival ("PFS") compared with TAGRISSO monotherapy. The combination also showed highly encouraging clinical benefit in overall survival ("OS"), one of the study's secondary endpoints. These results were presented in the Proffered Paper session at the 2026 European Society for Medical Oncology ("ESMO") Congress held in Madrid, Spain (abstract number #LBA69). PFS benefit was observed in both the high-level MET (IHC 3+) population and the intention-to-treat ("ITT") population (IHC 2+, IHC 3+). In the ITT population, the combination of ORPATHYS and TAGRISSO reduced the risk of disease progression or death by 44% compared with TAGRISSO monotherapy (based on PFS hazard ratio ["HR"] 0.56; 95% confidence interval ["CI"] 0.43-0.74; p<0.0001). Median PFS for the combination exceeded 2 years (24.9 months), compared with approximately 1 year (13.8 months) for TAGRISSO monotherapy. In the high-level MET population, the combination of ORPATHYS and TAGRISSO reduced the risk of disease progression or death by 55% compared with TAGRISSO monotherapy (PFS HR 0.45; 95% CI 0.31-0.66; p<0.0001). The ORPATHYS and TAGRISSO combination extended median PFS by 13.7 months (24.8 months vs. 11.1 months). For the secondary endpoint of OS, in the ITT population, the combination of ORPATHYS and TAGRISSO showed a clinically meaningful OS improvement compared with TAGRISSO monotherapy (OS HR 0.48; 95% CI 0.33-0.68). Compared with the control arm, the ORPATHYS and TAGRISSO combination extended median OS by 9.6 months (44.5 months vs. 34.9 months). An estimated 67.4% of patients in the combination arm were still alive at 3 years, compared with 47.4% in the control arm. With longer follow-up, the OS curves continued to separate, indicating that the magnitude of benefit from the ORPATHYS and TAGRISSO combination further widened over time. Notably, consistent PFS and OS benefits were observed across all prespecified ITT subgroups. Professor Wu Yilong of Guangdong Provincial People's Hospital, the principal investigator of the study, said: "The SANOVO study results represent a breakthrough change in the first-line treatment of EGFR-mutated lung cancer. In the past, patients with concurrent MET alterations often had a poorer prognosis when receiving EGFR-TKI treatment, underscoring the need to increase the uptake of MET alteration testing at diagnosis and disease progression. These results, which have the potential to reshape clinical practice, show that adding savolitinib to osimertinib in the first-line treatment of EGFR-mutated lung cancer with MET overexpression extended median PFS by more than 1 year in the high-level MET population and by 11 months in the overall population. Together with the equally encouraging clinical benefit in OS, these data further confirm the breakthrough potential of this combination, offering an all-oral, biomarker-guided treatment option for patients who have difficulty achieving long-term benefit from EGFR-TKI monotherapy due to MET overexpression." Mr. Zheng Zefeng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, said: "The SANOVO study, together with the SAFFRON and SACHI studies, collectively builds a comprehensive continuum of treatment with the ORPATHYS and TAGRISSO combination regimen, from first-line intervention to post-EGFR-TKI resistance. The SANOVO study confirms that identifying MET overexpression at diagnosis and adopting an all-oral dual-target combination regimen early can deliver clinically significant PFS and OS benefits while maintaining patients' quality of life. SANOVO further validates our core strategy of improving long-term clinical outcomes for patients by advancing precision oncology into earlier lines of treatment." Dr. He Jing, Senior Vice President of AstraZeneca and Head of Global R&D China, said: "The results of the SANOVO study echo the efficacy already demonstrated in the SAFFRON and SACHI studies, bringing the combination of ORPATHYS and the cornerstone therapy TAGRISSO to first-line treatment and delivering benefits to patients with EGFR-mutated lung cancer who also have MET overexpression. This all-oral, biomarker-guided combination therapy simultaneously targets the EGFR and MET pathways, improving progression-free survival and overall survival in patients with this disease. These results enable us to further advance our strategy of redefining the treatment standard for patients with EGFR-mutated lung cancer by providing innovative targeted combination therapies."