Akeso's Ivonescimab and Chemotherapy Combination Approved for Lung Cancer
China's National Medical Products Administration (NMPA) has approved Akeso's ivonescimab injection combined with chemotherapy for first-line treatment of advanced squamous non-small cell lung cancer.
Akeso, Inc. announced that China's National Medical Products Administration (NMPA) has approved its supplemental New Drug Application (sNDA) for ivonescimab injection in combination with chemotherapy. This combination is indicated for the first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC).
The approval is based on results from the HARMONi-6 Phase III clinical trial. The trial demonstrated that ivonescimab plus chemotherapy significantly improved progression-free survival compared to chemotherapy alone, meeting its primary endpoint.
Ivonescimab is a bispecific antibody developed by Akeso, targeting both PD-1 and VEGF. The company believes this combination therapy establishes a new standard of care for the first-line treatment of squamous NSCLC.
The HARMONi-6 study also showed improvements in overall survival and objective response rate. Akeso plans to submit data to regulatory authorities in the United States and Europe.