Akeso's Ivonescimab Surpasses Pembrolizumab in NSCLC Survival Study — Akeso, Inc.

Event summary

Akeso's ivonescimab met the key secondary endpoint of overall survival (OS) in the Phase III HARMONi-2 study, showing statistically significant and clinically meaningful improvement over pembrolizumab.
The trial evaluated ivonescimab as a first-line treatment for PD-L1-positive non-small cell lung cancer (NSCLC).
In May 2024, ivonescimab met its primary endpoint of progression-free survival (PFS) with a median PFS of 11.14 months versus 5.82 months for pembrolizumab.
Ivonescimab received regulatory approval in China in 2025, removing restrictions on VEGF-targeted agents for squamous histology and providing a chemotherapy-free treatment option.

The big picture

Akeso's ivonescimab represents a significant advancement in NSCLC treatment, combining immunotherapy and anti-angiogenesis in a single therapy. The positive Phase III results position ivonescimab as a potential market disruptor, challenging the dominance of pembrolizumab and other PD-1/PD-L1 inhibitors. The approval in China and ongoing trials suggest a broader strategic play to establish ivonescimab as a cornerstone in Akeso's oncology portfolio.

What we're watching

Clinical Validation: Whether ivonescimab's dual positive OS and PFS outcomes can be replicated across other solid tumors, strengthening its position as a best-in-class therapy.
Regulatory Expansion: The pace at which ivonescimab secures regulatory approvals outside China, particularly in major markets like the U.S. and Europe.
Market Penetration: How Akeso leverages these results to gain market share in the competitive NSCLC treatment landscape, potentially displacing established PD-1/PD-L1 therapies.