Policy & Regulation
Akeso doses first patient in Phase III Ivonescimab small cell lung cancer trial
11 August 2025 -

Akeso Inc (9926.HK) a China-based pharmaceutical company, announced on Sunday that the first patient has been dosed in its multicentre, randomised, double-blind Phase III study (AK112-311/HARMONi-9), evaluating ivonescimab, a first-in-class PD-1/VEGF bispecific antibody developed by Akeso, in small cell lung cancer (SCLC).

According to the company, this study is designed to assess the efficacy and safety of ivonescimab as consolidation therapy in patients with limited-stage small cell lung cancer (LS-SCLC) who have not experienced progression following standard concurrent chemoradiotherapy (cCRT).

AK112-311/HARMONi-9 study is the eighth registrational Phase III clinical trial for ivonescimab in lung cancer (including three international multicenter studies).

The company says that in previous studies focused on extensive-stage SCLC (ES-SCLC), ivonescimab has demonstrated its ability to prolong progression-free survival (PFS), combining the synergistic benefits of PD-1/L1 inhibitors and anti-angiogenic agents.

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