Companies to initiate Phase III registrational trials in first-line NSCLC across the spectrum of PD-L1 expression and first-line head and neck cancer in 2017.

Bristol-Myers Squibb (BMS) and Incyte have agreed to advance their clinical development program evaluating the combination of epacadostat, Incyte’s investigational oral selective IDO1 enzyme inhibitor, with Opdivo (nivolumab), BMS’s PD-1 immune checkpoint inhibitor, into Phase III registrational studies in first-line non-small cell lung cancer across the spectrum of PD-L1 expression and first-line head and neck cancer. In addition, the companies are expanding the ECHO-204 Phase I/II study, established under a collaboration between the companies in 2014, to include anti-PD-1/PD-L1 relapsed/refractory melanoma cohorts. The expanded clinical development program, including the PhaseIII3 registrational studies, will be co-funded by the two companies.

"We are pleased to build upon our existing collaboration with Incyte and advance the clinical development of epacadostat combined with Opdivo into Phase III registrational trials," said Fouad Namouni, head of Development, Oncology, BMS. "Incyte shares our goal of improving clinical outcomes for patients with some of the hardest-to-treat cancers, and we look forward to working together on studies evaluating the clinical outcomes of this therapeutic combination."

"We are very pleased to expand our partnership with BMS and move the combination of epacadostat plus Opdivo forward into pivotal studies," said Steven Stein, Chief Medical Officer, Incyte. "We believe that further expanding the ECHO development program for epacadostat, including the initiation of these new Phase III trials, will bring us closer to our goal of providing new treatment options for patients with certain cancers."