HUTCHMED has completed enrollment in its China Phase III SANOVO trial evaluating savolitinib plus osimertinib as a first-line treatment for NSCLC patients with EGFR mutations and MET overexpression. Topline results are anticipated in the second half of 2026.
The SANOVO trial completion marks another key step in HUTCHMED and AstraZeneca’s collaborative strategy to expand the use of savolitinib in the increasingly complex landscape of targeted NSCLC therapies. This particular study zeroes in on the first-line setting for patients with both EGFR mutations and MET overexpression, aiming to demonstrate improved progression-free survival compared to osimertinib monotherapy, which is the current standard of care. This combination approach aims to address both primary driver mutations and potential resistance mechanisms upfront, a strategy that reflects the evolving understanding of NSCLC heterogeneity and the ongoing pursuit of more durable responses.
The focus on MET overexpression as a stratification factor underscores the growing recognition of its role in both de novo and acquired resistance to EGFR TKIs. While savolitinib has already secured Chinese approval for second-line use in MET-driven NSCLC following progression on EGFR TKIs, success in SANOVO would significantly broaden its market reach by positioning the drug as a first-line option. This could have major implications for treatment algorithms and potentially delay the need for subsequent lines of therapy, particularly in Asian populations where MET overexpression is more prevalent.
The trial design itself reflects several important trends in oncology trials. The inclusion of both investigator-assessed and independent review committee-assessed progression-free survival as endpoints speaks to the increasing emphasis on rigorous and unbiased evaluation of treatment efficacy. The broader set of secondary endpoints, including overall survival, objective response rate, and safety, provides a comprehensive dataset that will be crucial not only for regulatory submissions but also for payer negotiations and clinical practice adoption.
Looking ahead, the SANOVO readout will be critical for HUTCHMED’s broader ambitions in the NSCLC space. Positive results could reshape the treatment paradigm, prompting a shift towards earlier utilization of combination therapies and creating a new market for MET-targeted agents in the first-line setting. However, the trial faces challenges. The chosen patient population, with both EGFR mutations and MET overexpression, represents a subset of the broader NSCLC population. Demonstrating a clear benefit in this group will be essential, but may not fully capture the drug’s potential impact across the spectrum of NSCLC. Furthermore, competition in the EGFR-mutated NSCLC space is intensifying, with multiple other targeted therapies and combination strategies under development. The SANOVO outcome, therefore, will not only impact savolitinib’s trajectory but also contribute to defining the optimal sequencing and combination strategies for this increasingly complex disease landscape. The data will be scrutinized for both statistical significance and clinically meaningful improvements to solidify the combination’s place in front-line NSCLC treatment.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
