Akeso Advances Lung Cancer Combination Therapy with Phase Ib/II Trial — Akeso, Inc.

Event summary

First patient dosed in Phase Ib/II study of HER3 ADC (AK138D1) combined with ivonescimab for advanced non-small cell lung cancer (NSCLC).
Study evaluates Akeso's IO2.0 + ADC2.0 regimen across first-line treatment, EGFR-TKI resistance, and immuno-chemotherapy resistance settings.
AK138D1 designed to minimize off-target toxicity and improve tumor penetration, with early studies showing potent anti-tumor activity and favorable safety profile.
Ivonescimab, a PD-1/VEGF bispecific antibody, has shown strong clinical results in Phase III studies and is expected to amplify immune-activating effects when combined with AK138D1.

The big picture

Akeso is systematically building a comprehensive global IO2.0 + ADC2.0 therapeutic matrix, leveraging its technological leadership in bispecific and multi-specific antibodies. The company's approach aims to drive global treatment paradigm upgrades for major malignancies, including lung cancer and breast cancer, through innovative combination therapies.

What we're watching

Clinical Efficacy: Whether the combination of AK138D1 and ivonescimab will deliver superior clinical efficacy across various NSCLC subtypes while maintaining a favorable safety profile.
Regulatory Approval: The pace at which Akeso can obtain regulatory approvals for its next-generation HER3 ADC and combination therapies, given the current limitations of traditional HER3 ADCs.
Pipeline Development: How Akeso's differentiated pipeline of next-generation ADC candidates will position it in the competitive landscape of immuno-oncology and ADC therapies.