China-based biopharmaceutical company Akeso, Inc. (HKEX: 9926.HK) announced on Wednesday that it has received priority review from China's State Drug Administration (NMPA CDE) for the supplemental New Drug Application (sNDA) for ivonescimab, intended as a monotherapy for first-line treatment of PD-L1 positive (PD-L1 TPS greater than or equal to 1%) locally advanced or metastatic non-small cell lung cancer (NSCLC).

Ivonescimab is a first-in-class PD-1/VEGF bi-specific antibody developed by Akeso. This is the second indication for which ivonescimab has been granted priority review following the treatment of EGFR-mutant non-squamous NSCLC that has progressed after EGFR-TKI therapy.

This new indication application for ivonescimab is based on the HARMONi-2 (AK112-303) study. At a prespecified interim analysis conducted by an independent Data Monitoring Committee, Akesa says that ivonescimab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) by blinded independent radiology review committee (BICR) compared to pembrolizumab, and the hazard ratio (HR) was significantly better than expected. There are no known Phase III clinical trials in NSCLC which have shown a statistically significant improvement compared to pembrolizumab in a head-to-head setting.