M7824 is a bifunctional monoclonal antibody targeting programmed death ligand 1 (PD-L1) and transforming growth factor-beta. The use of this drug represents a form of combination immunotherapy. Thirteen patients with advanced NSCLC have enrolled in the biomarker cohort. This includes 8 patients who have previously received immunotherapy and 5 patients who have not received immunotherapy. Three (23%) patients experienced a partial response including 2 (40%) of 5 patients who had not received immunotherapy previously. Treatment was well tolerated and the frequency of immune-related adverse events was not higher than that observed with anti-PD-1/PD-L1 monotherapy. Analysis of tissue and blood samples demonstrate tumor necrosis and immune activation. The biomarker cohort has nearly completed enrollment and we expect to publish results of this trial in the near future.
