Key Takeaways:
Akeso Inc. is set to unveil crucial overall survival data for its dual-action cancer therapy, ivonescimab, positioning the drug for a direct challenge to established treatments in the lucrative lung cancer market. The results from the Phase III HARMONi-6 study will be featured in a prestigious plenary session at the American Society of Clinical Oncology (ASCO) annual meeting on May 31, a forum reserved for data with the potential to change clinical practice.
"The big debate is, what does this look like in overall survival?" Daina Graybosch, senior managing director of immuno-oncology at Leerink Partners, said in an interview with BioSpace. The answer, she noted, will help determine where ivonescimab and other bispecifics fit in the treatment landscape, adding, "How much better than Keytruda is it going to be?"
The China-only HARMONi-6 trial evaluates ivonescimab, a first-in-class bispecific antibody targeting both PD-1 and VEGF, combined with chemotherapy in patients with advanced squamous non-small cell lung cancer (sq-NSCLC). The comparator arm is tislelizumab, a PD-1 inhibitor, plus chemotherapy. At the 2025 ESMO congress, the study showed a median progression-free survival of 11.14 months for the ivonescimab arm versus 6.9 months for the control group, a statistically significant improvement that now requires a corresponding survival benefit to confirm its clinical advantage.
The presentation is the main event for Akeso (9926.HK), which will feature data from over 40 clinical studies at the conference. A strong overall survival result from HARMONi-6 could solidify the drug's standing against Merck's multi-billion dollar blockbuster Keytruda, the current standard of care for first-line NSCLC. However, with recent global trials of ivonescimab missing endpoints, analysts remain cautious about whether the compelling results from Chinese patient populations will be replicated worldwide.
Ivonescimab is the lead asset in Akeso's pipeline of over 50 drug candidates, which is built around its proprietary Tetrabody antibody technology platform. The company has 27 candidates in clinical trials, including 15 bispecific antibodies. This strategy of targeting two different mechanisms of disease with a single molecule is a core focus for the company and a growing trend in oncology.
Beyond lung cancer, Akeso will present data for ivonescimab in other indications at ASCO, including small-cell lung cancer and metastatic colorectal cancer. The company will also showcase its second major bispecific, cadonilimab, which targets PD-1 and CTLA-4. Data for cadonilimab-based regimens will be presented in several cancers, including renal cell carcinoma, melanoma, and gynecologic malignancies, demonstrating the breadth of Akeso's approach.
The ASCO meeting will also feature data from other companies developing PD-1/VEGF bispecifics, including Bristol Myers Squibb and Pfizer, indicating a crowded and competitive field. Akeso's potential success hinges on demonstrating a clear and substantial survival benefit that can convince regulators and clinicians to adopt its therapy over existing single-target PD-1 inhibitors.
For investors, the HARMONi-6 data is a primary catalyst. A definitive overall survival win would likely send shares of Akeso, and its US partner Summit Therapeutics, higher and validate its bispecific platform. A failure to show a significant survival benefit, or a result that is only marginally better than the standard of care, could temper expectations for the drug's global commercial prospects. The company has not disclosed its current cash runway.
This article is for informational purposes only and does not constitute investment advice.
