China-based biotech Akeso Inc. (HKG: 9926) announced the completion of patient enrollment in the global Phase III clinical trial (HARMONi-6/AK112-306) assessing its PD-1/VEGF bispecific antibody (BsAb) ivonescimab. The trial compares ivonescimab combined with platinum-based chemotherapy to PD-1 inhibitor tislelizumab in combination with platinum-based chemotherapy in first-line squamous non-small cell lung cancer (sq-NSCLC).
Global Clinical Development
The HARMONi-6/AK112-306 trial is one of six registrational/Phase III studies worldwide for ivonescimab in lung cancer. It is also one of six studies where PD-1/L1 inhibitors are used as comparators. Several international Phase III clinical trials of ivonescimab are underway, including the HARMONi-3 clinical trial, which compares ivonescimab plus chemotherapy to pembrolizumab plus chemotherapy for the first-line treatment of both sq-NSCLC and non-squamous NSCLC (nsq-NSCLC).
Regulatory Milestones
Ivonescimab is the world’s first PD-1/VEGF BsAb. It was previously approved in China in May 2024 for the treatment of first-line nsq-NSCLC with EGFR mutations in patients who progress after EGFR-TKI treatment. This indication was included in the National Reimbursement Drug List (NRDL) in November of the same year.
Future Outlook
With the completion of patient enrollment in the HARMONi-6/AK112-306 trial, Akeso is poised to advance its clinical development program for ivonescimab. The results of this trial are expected to provide further insights into the potential benefits of ivonescimab in treating lung cancer, supporting its global market potential.-Fineline Info & Tech
