China-based Akeso, Inc. (HKG: 9926) announced that its supplementary New Drug Application (sNDA) for ivonescimab, a first-in-class PD-1/VEGF bispecific antibody (BsAb), has been approved by the National Medical Products Administration (NMPA). The therapy is now approved for use as a monotherapy in first-line treatment of PD-L1-positive (TPS ≥ 1%) non-small cell lung cancer (NSCLC) patients who are negative for epidermal growth factor receptor (EGFR) gene mutations and anaplastic lymphoma kinase (ALK) gene mutations.
Clinical Trial Results
The approval is based on positive results from the Phase III AK112-303/HARMONi-2 study. Ivonescimab demonstrated a statistically significant improvement in median progression-free survival (PFS) compared to pembrolizumab, with a median PFS of 11.14 months and a hazard ratio (HR) of 0.51, reducing the risk of disease progression or death by 49%. This marks the first therapy to achieve statistically significant positive results in a Phase III trial compared with pembrolizumab in a head-to-head setting.
Previous Approvals and Indications
Ivonescimab, the world’s first BsAb with a dual “cancer immunotherapy + anti-angiogenesis” mechanism, was previously approved in China in May 2023 for first-line treatment of non-squamous NSCLC with EGFR mutations in patients who progress after EGFR-TKI treatment. The drug was included in the National Reimbursement Drug List (NRDL) in November 2023 for this indication.-Fineline Info & Tech
