Summit Therapeutics Inc. (NASDAQ:SMMT) stock is trading higher on Thursday after its development partner, Akeso Inc., reported highly favorable overall survival data from a late-stage clinical trial.
The Phase 3 HARMONi-2 study evaluated ivonescimab as a standalone treatment against Merck & Co Inc.’s (NYSE:MRK) Keytruda (pembrolizumab) for locally advanced or metastatic non-small cell lung cancer (NSCLC) presenting positive PD-L1 expression.
Positive Overall Survival Results
The multi-center trial took place exclusively in China, with Akeso generating, managing, and analyzing all relevant clinical data.
In a preplanned clinical analysis, Akeso revealed that ivonescimab monotherapy provided a statistically significant improvement in overall survival compared to pembrolizumab.
Overall survival served as a secondary endpoint in the HARMONi-2 study.
The company plans to present the comprehensive findings from this analysis at an upcoming medical conference.
Prior Clinical Milestones And Approvals
China’s National Medical Products Administration previously granted marketing authorization for ivonescimab in April 2025, driven by the initial HARMONi-2 results.
During the primary analysis, the Independent Radiologic Review Committee determined that ivonescimab monotherapy showed a significant enhancement in progression-free survival when compared directly to pembrolizumab.
The treatment achieved a hazard ratio of 0.51. Furthermore, the drug demonstrated a clinically meaningful benefit across a variety of patient subgroups.
These subgroups included individuals with high and low PD-L1 expression, alongside those featuring squamous and non-squamous tumor histologies.
Current Regulatory Status
While ivonescimab is fully approved and commercially accessible for NSCLC indications in China, its regulatory standing differs significantly in other global markets.
The therapy remains strictly investigational within Summit Therapeutics’ licensed territories.
SMMT Price Action: Summit Therapeutics shares were up 10.79% at $15.55 at the time of publication on Thursday, according to Benzinga Pro data.
Photo by Piotr Swat via Shutterstock
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