Merck Inc.and Incyte Corpn. announce extended development programme for combinations of Keytruda (pembrolizumab) and epacadostat.
Incyte Corporation and Merck announced additional details of their clinical development program investigating the combination of epacadostat, Incyte’s investigational oral selective IDO1 enzyme inhibitor, with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in patients across five tumor types: metastatic melanoma, non-small cell lung cancer (NSCLC), bladder cancer, renal cell carcinoma (RCC), and squamous cell carcinoma of the head and neck (SCCHN).
The expanded collaboration now includes seven pivotal studies . 1.A Phase III study in metastatic melanoma (trial underway); 2. Two Phase III studies in first-line NSCLC, including both PD-L1 high-expressing and PD-L1 unselected populations; 3. Two Phase III studies in bladder cancer, including one in first-line bladder cancer and one in second-line bladder cancer; 4. A Phase III study in first-line RCC; and 5. A Phase III study in first-line SCCHN. Incyte and Merck will share responsibilities for funding these pivotal studies, and Merck will be responsible for conducting the trials.