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China has authorized Summit Therapeutics’ (NASDAQ:SMMT) lead candidate, ivonescimab, as a combination therapy for certain forms of lung cancer, the drug’s Chinese developer, Akeso (OTCPK:AKESF), announced Friday.
The marketing authorization has been issued by China’s National Medical Products Administration (NMPA) allowing the use of the bispecific antibody as a second-line option in combination with chemotherapy for non-small cell lung cancer (NSCLC).
To be eligible, patients should be positive for mutations in the gene for the epidermal growth factor receptor. This group has not favorably responded to a drug class known as PD-1 monoclonal antibodies in Phase 1 development in the past.
The approval was based on data from Akeso’s (OTCPK:AKESF) HARMONi-A Phase 3 trial conducted in China. In conjunction with the release, the company said HARMONi-A data has been published in the medical journal JAMA.
A readout from Akeso’s (OTCPK:AKESF) HARMONi-2 Phase 3 trial, which tested ivonescimab against Merck’s (MRK) Keytruda in lung cancer, sent Summit (SMMT) sharply higher this week.
