A global phase-2 clinical trial will soon take place in Korea to check if a combination therapy of BMS' Yervoy (ipilimumab) and Cemiplimab will be effective to treat non-small cell lung cancer (NSCLC).
The Ministry of Food and Drug Safety on Monday gave the green light to the phase-2 study on REGN2810, which is another name of Cemiplimab developed by Sanofi and Regeneron Pharmaceuticals.
Cemiplimab is a human monoclonal antibody targeting PD-1. Regeneron applied its exclusive technology "VelocImmune" to the investigational therapy.
The upcoming trial in Korea will be on 35 patients with metastatic NSCLC whose tumors expressing PD-L1 less than 50 percent.
The study will be a randomized and open-label study of combinations of REGN2810 (Cemiplimab, anti-PD-1 antibody) and ipilimumab (anti-CTLA-4 antibody).
The trial will take place at Catholic University Seoul St. Mary’s Hospital, Asan Medical Center, Severance Hospital, St. Vincent Hospital, Inha University Hospital, Ulsan University Hospital, and Bundang Seoul National University Hospital.
Cemiplimab is being tested in global clinical trials to check its efficacy in squamous cell carcinoma, basal cell carcinoma, NSCLC, renal cell carcinoma, and cervical cancer. In September last year, the U.S. Food and Drug Administration designated it as an innovative treatment for skin squamous cell carcinoma.