Akeso - Study meets key secondary endpoints of progression-free survival and objective response rate

Akeso Inc. (HKEX: 9926.HK) recently reported that its Phase II clinical trial of ivonescimab in first-line metastatic colorectal cancer (mCRC) met key secondary endpoints, including progression-free survival (PFS) and objective response rate (ORR). The study, conducted in collaboration with Summit Therapeutics Inc. (NASDAQ: SMMT), was presented at ASCO 2026.

The trial evaluated ivonescimab in combination with mFOLFOX6 chemotherapy in 49 treatment-naïve patients with unresectable microsatellite stable (MSS) mCRC. The overall study population achieved an ORR of 70.8% across both dose levels (10 mg/kg and 20 mg/kg), with a disease control rate (DCR) of 100.0%. The 9-month PFS rate for patients receiving the 20 mg/kg dose was 76.1%, while duration of response was more durable in this group compared to the 10 mg/kg cohort.

Safety data from the trial indicated an acceptable and manageable profile, with no new safety signals observed. Serious treatment-related adverse events occurred in 20.4% of patients, and no treatment-related deaths were reported.

These findings add to the growing body of evidence supporting ivonescimab’s potential as a differentiated PD-1 / VEGF bispecific antibody. Akeso and Summit are currently conducting the global Phase III HARMONi-GI3 trial, which compares ivonescimab plus mFOLFOX6 to bevacizumab plus mFOLFOX6 in first-line unresectable mCRC.

The results from this Phase II trial underscore the ongoing development of ivonescimab across multiple tumor types and reinforce its role in addressing unmet needs in oncology.