Ivonescimab Beats Pembrolizumab in NSCLC Survival Study — Summit Therapeutics Inc.

Event summary

Ivonescimab monotherapy demonstrated a statistically significant overall survival benefit (HR 0.73, p=0.009) compared to pembrolizumab in PD-L1-positive advanced NSCLC in the HARMONi-2 study.
Median overall survival was 30.8 months for ivonescimab vs. 22.6 months for pembrolizumab in the intention-to-treat population.
The study was conducted by Akeso in China and presented at the 2026 World Conference on Lung Cancer.
Ivonescimab received marketing authorization in China in April 2025 based on earlier HARMONi-2 results.

The big picture

This study positions ivonescimab as a potential next-generation immuno-oncology therapy, combining PD-1 blockade with anti-angiogenesis effects. The results challenge the current standard of care with pembrolizumab and could reshape treatment paradigms for NSCLC. Summit's ability to leverage these data globally will be critical for commercial success.

What we're watching

Global Expansion: Whether Summit can replicate these results in its global HARMONi-7 study, which is currently recruiting patients with high PD-L1 expression NSCLC.
Regulatory Pathway: The timeline for potential FDA approval of ivonescimab, with a BLA submission accepted in January 2026 and a PDUFA date of November 14, 2026.
Pipeline Diversification: The progress of Summit's additional Phase III trials in colorectal cancer, urothelial carcinoma, and other indications, which could broaden ivonescimab's potential market.