Akeso's Ivonescimab Redefines Lung Cancer Treatment with NMPA Approval
Event summary
- Akeso's ivonescimab plus chemotherapy approved by NMPA for first-line advanced squamous NSCLC on August 12, 2026.
- Phase III HARMONi-6 study showed 34% reduction in death risk vs. PD-1 inhibitor plus chemotherapy (HR=0.66).
- Median OS improved to 27.9 months with ivonescimab vs. 23.7 months in control arm.
- First China-originated novel therapy featured in an ASCO Plenary Session.
The big picture
Akeso's approval marks a significant shift in lung cancer treatment, establishing ivonescimab as a new standard of care. The success of the HARMONi-6 study highlights the potential of next-generation immuno-oncology therapies to outperform existing PD-1 inhibitors. This development positions Akeso at the forefront of the IO2.0 era, with implications for both lung and breast cancer treatment landscapes.
What we're watching
- Global Expansion
- Whether Akeso can replicate ivonescimab's success in international markets beyond China.
- Pipeline Development
- The pace at which Akeso advances its IO2.0 + ADC2.0 strategy with combination studies.
- Competitive Positioning
- How ivonescimab's PD-1/VEGF bispecific mechanism will challenge existing PD-1 therapies.
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