Incyte and Merck Provide Additional Details on Previously Announced Collaboration Investigating Epac

Incyte Corporation and Merck have 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:

• A Phase 3 study in metastatic melanoma (trial underway);
• two Phase 3 studies in first-line NSCLC, including both PD-L1 high-expressing and PD-L1 unselected populations;
• two Phase 3 studies in bladder cancer, including one in first-line bladder cancer and one in second-line bladder cancer;
• a Phase 3 study in first-line RCC; and
• a Phase 3 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.

"We are pleased to announce further details of our collaboration with Merck and to be moving forward with multiple Phase 3 studies in these four additional tumor types as quickly as possible," said Steven Stein, M.D., Chief Medical Officer, Incyte. "We look forward to our continued clinical collaboration, the initiation of these additional pivotal trials and to further exploring the potential of this novel immune-therapy combination as a treatment for patients with cancer."

"Our clinical trial program with Incyte represents an important part of our multi-pronged efforts to investigate the potential for KEYTRUDA (pembrolizumab) in combination with promising compounds, such as epacadostat," said Dr. Roy Baynes, senior vice president, head of clinical development, and Chief Medical Officer, Merck Research Laboratories. "Through these trials, our long-term goal is to help make a difference in the lives of people with a wide range of cancers."