solidcolours 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. More on Akeso, Summit Therapeutics, etc. Summit Therapeutics Stock: Plunging Despite A Win? Summit: A Few Catalysts In Q2 Of 2024 To Carry The Tide Summit Therapeutics' Ivonescimab: Strong Buy Its Dual-Action Approach To Cancer Summit pares gains as ‘China-only’ trial beats Merck’s Keytruda (update) Summit lead asset beats Merck’s Keytruda in a first in lung cancer.