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On March 10, the CDE official website showed that the clinical application of Merck’s MK-7684A injection has been accepted by the CDE.
The vibostolimab in the compound preparation is a monoclonal antibody targeting the immune cell protein receptor TIGIT developed by Merck, and pembrolizumab is an anti-PD-1 monoclonal antibody.
At the ESMO virtual conference held in September 2020, Merck announced the Part B data of the first human, open label, phase I (NCT02964013) study.
The results of the study show that vibostolimab combined with KEYTRUDA has manageable safety and shows potential anti-tumor activity.
Among all included patients, the ORR of vibostolimab combined with KEYTRUDA was 29%, and the median PFS was 5.
At the same time, another separate cohort of the study evaluated the efficacy of vibostolimab monotherapy (n=41) or combined with KEYTRUDA (n=38) in patients with advanced disease and metastatic NSCLC who had received anti-PD-1/PD-L1 treatment before treatment.
The results of the study show that Vibostolimab monotherapy or combination therapy with KEYTRUDA has manageable safety, and shows anti-tumor activity in patients with PD-1/PD-L1 refractory.
At the same time, in the NCT02964013 study, Merck also carried out the safety and PK trials of vibostolimab+pembrolizumab fixed-dose compound preparation (MK-7684A) and vibostolimab combined with pembrolizumab intravenously.
