Akeso Reports Survival Benefit in Phase III Lung Cancer Trial, Enrolls First Patient in Breast Cancer Study
Akeso reported overall survival benefit for ivonescimab plus chemotherapy in Phase III lung cancer study. The company enrolled first patient in Phase Ib/II trial of next-generation HER3 ADC AK138D1 for advanced breast cancer. Akeso also received China approval to start Phase II trials for AK139 bispecific antibody.
Akeso, Inc. (HKEX: 9926) has reported an overall survival benefit for ivonescimab plus chemotherapy in a Phase III lung cancer study, positioning the PD-1/VEGF bispecific antibody as a potential competitor in first-line non-small cell lung cancer. The company also announced that the first patient has been enrolled in a Phase Ib/II clinical study evaluating its next-generation HER3 antibody-drug conjugate (ADC), AK138D1, as monotherapy or combined with ivonescimab for advanced breast cancer.
The Phase Ib/II study (AK138D1-202) focuses on two major breast cancer subtypes with significant unmet need: hormone receptor-positive, HER2-negative (HR+/HER2-) disease, which accounts for approximately 65% of all breast cancers, and triple-negative breast cancer (TNBC), representing 10-20% of cases. Breast cancer remains the most common cancer among women worldwide, with an estimated 2.3 million new cases diagnosed annually.
AK138D1 is engineered to reduce uptake in normal tissues, minimizing off-target toxicities and widening the therapeutic window. Early-stage clinical studies conducted in China and Australia have demonstrated robust anti-tumor activity in solid tumors and breast cancer, coupled with an excellent safety profile characterized by low hematologic toxicity and the absence of interstitial lung disease. Concurrently, a Phase III study of ivonescimab-based combination therapy in first-line TNBC is ongoing.
Akeso has also received approval in China to start Phase II trials for AK139, a first-in-class IL-4Ra/ST2 bispecific antibody, targeting seven respiratory and autoimmune conditions. The company is strategically building a comprehensive portfolio of IO+ADC combinations, leveraging its proprietary platforms in bispecific and multispecific antibody technologies.
Financial data indicates Akeso's 1-year total shareholder return of 74.92%, reflecting strong longer-term momentum despite recent volatility. The company is still loss-making, with analysts noting potential risks from cadonilimab pricing cuts and ongoing operating losses. Akeso's price-to-sales ratio stands at 34.1x, compared to the Hong Kong Biotechs average of 14.2x.