Ivonescimab Monotherapy Demonstrates Statistically Significant Overall Survival Benefit Compared to Pembrolizumab Monotherapy in PD-L1-Positive Advanced NSCLC in HARMONi-2 Study Conducted by Akeso in China
Wednesday, September 2, 2026 BiopharmaWatch Research 1 min read
Key Takeaway: Summit Therapeutics' partner Akeso has reported positive results from the Phase III HARMONi-2 study. The trial demonstrated that ivonescimab monotherapy significantly improves overall survival compared to pembrolizumab in patients with PD-L1-positive advanced non-small cell lung cancer. This finding could impact treatment strategies in this patient demographic.
Price reaction · baseline $14.6 (2026-09-02 close) · hit after-hours · clean, no other SMMT news in the window
The study was conducted in a well-defined patient population.
Results may enhance treatment options for advanced NSCLC.
BiopharmaWatch Analysis
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Best trade, last catalyst
+1236%
120-day peak, hindsight
Typical move
47.7%
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Cash runway
~14 mo
Low dilution risk
Lead asset
Ivonescimab
Phase 3 · Non-Small Cell Lung Cancer
Full Press Release Details
MIAMI--(BUSINESS WIRE)---- $SMMT--Summit Therapeutics Inc. (NASDAQ: SMMT) today noted that its partner Akeso Inc. announced positive overall survival (OS) results from the randomized, double-blind Phase III HARMONi-2 study evaluating ivonescimab monotherapy against pembrolizumab monotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression. HARMONi-2 (AK112-303) is a single-region, multi-center Phase III study conducted in China
Frequently Asked Questions
What is the HARMONi-2 study about?
The HARMONi-2 study evaluates ivonescimab monotherapy against pembrolizumab in advanced NSCLC.
What were the results of the HARMONi-2 study?
The study showed that ivonescimab significantly improved overall survival compared to pembrolizumab.
Who conducted the HARMONi-2 study?
The study was conducted by Akeso Inc. in China.
What type of cancer was targeted in the study?
The study targeted locally advanced or metastatic non-small cell lung cancer.