Akeso: China's NMPA Accepts Ivonescimab + Chemo SNDA As First-Line Treatment For Advanced Sq-NSCLC

(RTTNews) - Biopharmaceutical company Akeso Inc. (AKESF) announced Monday that China's National Medical Products Administration or NMPA has accepted the supplementary New Drug Application or sNDA for ivonescimab (PD-1/VEGF bispecific antibody) in combination with chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer or sq-NSCLC.

The decision is based on positive outcomes from the Phase III HARMONi-6 study, which demonstrated the superiority of ivonescimab combined with chemotherapy over existing treatments.

The latest approval is the third accepted application for ivonescimab in China. Previous filings were for its combination therapy in EGFR-TKI resistant locally advanced or metastatic non-squamous NSCLC (nsq-NSCLC), as well as its monotherapy for first-line treatment of PD-L1 positive advanced NSCLC.

Ivonescimab is currently involved in over 12 registrational/Phase III clinical trials worldwide, further establishing its role in global cancer immunotherapy. These include six head-to-head studies with PD-1/L1 inhibitors.

The trials are on various malignancies, including various subtypes of lung cancer, first-line colorectal cancer, first-line head and neck squamous cell carcinoma, first-line biliary tract cancer, first-line pancreatic cancer, and first-line triple-negative breast cancer, among others.

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