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Akeso Begins Phase III Trial of Bispecific Antibody, Chemo in EGFR-TKI Resistant NSCLC

NEW YORK – Akeso said on Sunday that it has begun dosing patients in a Phase III study of ivonescimab plus chemotherapy for advanced, EGFR-mutated non-squamous non-small cell lung cancer patients after treatment with an EGFR tyrosine kinase inhibitor.

In the registrational trial, the Hong Kong-based firm will pit its investigational PD-1/VEGF bispecific antibody plus chemo against chemo and placebo. The company will enroll roughly 320 patients at multiple trial sites in China and track their progression-free survival on treatment as a primary endpoint.

Ivonescimab is designed to stimulate antitumor immune responses while also inhibiting tumor angiogenesis. According to Akeso, the agent has shown encouraging safety and tolerability in early-phase clinical trials in Australia and China in both NSCLC and small cell lung cancer patients.

The newly initiated study is the first Phase III trial to evaluate a bispecific antibody in NSCLC patients resistant to EGFR TKIs. The firm plans to soon begin a second Phase III trial evaluating ivonescimab as first-line treatment in PD-L1-positive NSCLC and a third Phase III trial of the drug in first-line extensive SCLC.