ESMO 2026: HUTCHMED presents Phase III SANOVO data for Orpathys plus Tagrisso in first-line EGFR-mutated NSCLC

HUTCHMED Limited announces positive results from the SANOVO Phase III trial in China. Orpathys (savolitinib) plus Tagrisso (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in the primary endpoint progression-free survival (“PFS”) versus Tagrisso alone in treatment-naïve patients with epidermal growth factor receptor-mutated (“EGFRm”) locally advanced or metastatic non-small cell lung cancer (“NSCLC”) and MET overexpression. The combination also demonstrated very encouraging clinical benefit in overall survival (“OS”), a secondary endpoint of the trial.

These results have been presented in a Proffered Paper session at the 2026 European Society for Medical Oncology (“ESMO”) Congress in Madrid, Spain (abstract #LBA69).

PFS benefits were demonstrated in both the high MET (IHC 3+) and the intention-to-treat (“ITT”) trial populations (IHC 2+, IHC 3+). Orpathys plus Tagrisso reduced the risk of disease progression or death by 44% compared to Tagrisso alone in the ITT population (based on a PFS hazard ratio [“HR”] of 0.56; 95% confidence interval [“CI”] 0.43-0.74; p<0.0001). The combination demonstrated a median PFS of more than two years (24.9 months) compared to approximately a year (13.8 months) for Tagrisso alone.

In the high MET population, Orpathys plus Tagrisso reduced the risk of disease progression or death by 55% compared to Tagrisso alone (PFS HR of 0.45; 95% CI 0.31-0.66; p<0.0001). Orpathys plus Tagrisso extended median PFS by 13.7 months versus the comparator arm (24.8 versus 11.1 months).

For the secondary endpoint of OS in the ITT population, Orpathys plus Tagrisso showed a clinically meaningful improvement in OS (OS HR of 0.48; 95% CI 0.33-0.68) versus Tagrisso alone. Orpathys plus Tagrisso extended median OS by 9.6 months versus the comparator arm (44.5 versus 34.9 months). An estimated 67.4% of patients treated with the combination were alive at three years compared to 47.4% in the comparator arm. With longer follow-up, the OS curves showed continued separation, signaling a greater magnitude of benefit over time for the Orpathys plus Tagrisso combination. Importantly, the PFS and OS benefit observed was consistent across all prespecified ITT subgroups.

“The SANOVO results mark a pivotal evolution in how we approach first-line EGFR-mutated lung cancer. Historically, co-occurring MET alterations have been associated with poor outcomes on EGFR-TKI treatment, increasing the motivation to test for MET alterations at diagnosis and upon progression. These potentially practice-changing results showed that adding savolitinib to osimertinib extended median PFS by more than a year in the high MET population, and 11 months overall, in first-line MET-overexpressing EGFR-mutated lung cancer. Coupled with highly encouraging clinical benefit in OS, these data reinforce the transformative potential of this all-oral, biomarker-directed treatment approach for a patient population where co-occurring MET overexpression may limit the long-term benefits of EGFR-TKI monotherapy.” – Professor Yi-Long Wu of the Guangdong Provincial People’s Hospital, and the leading principal investigator of the trial.

“SANOVO, alongside the SAFFRON and SACHI studies, establishes a comprehensive treatment continuum for the Orpathys plus Tagrisso combination — spanning frontline intervention to post-EGFR-TKI resistance. SANOVO demonstrates that by identifying MET overexpression at diagnosis and initiating an all oral, dual-targeted combination upfront, we can meaningfully extend PFS and OS while preserving patient quality of life. SANOVO reinforces our strategy to improve long-term clinical outcomes for patients by advancing precision oncology into earlier lines of therapy.” – Mr Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED.

“The SANOVO results build on the proven efficacy seen in SAFFRON and SACHI, bringing the benefit of Orpathys plus backbone Tagrisso to first-line patients with EGFR-mutated lung cancer with co-occurring MET overexpression. By targeting both EGFR and MET pathways, this all-oral, biomarker-directed combination improved both progression-free and overall survival in this setting. These results allow us to further advance our strategy to redefine standards of care for patients with EGFR-mutated lung cancer by delivering novel, targeted combinations.” – Dr Jing He, Senior Vice President and Head of R&D China of AstraZeneca.

An additional presentation featured during a Presidential Symposium at the ESMO Congress highlighted data from the SAFFRON Phase III trial of Orpathys plus Tagrisso in MET-driven EGFRm NSCLC after progression on Tagrisso (abstract #LBA6).

Orpathys plus Tagrisso is approved in China for patients with locally advanced or metastatic EGFRm-positive non-squamous NSCLC with MET amplification after disease progression on EGFR-tyrosine kinase inhibitor (“TKI”) therapy based on the SACHI Phase III trial. Based on data from the SANOVO Phase III trial, HUTCHMED plans to submit a supplemental New Drug Application in China for this first-line setting.