Incyte, Bristol-Myers Squibb move epacadostat plus Opdivo combination into pivotal studies

Bristol-Myers Squibb and Incyte Corporation will evaluate combination of epacadostat with Opdivo in advancing a clinical development program into phase 3 registrational trials in first-line non-small cell lung cancer across the spectrum of PD-L1 expression and first-line head and neck cancer in 2017.

The studies will cover first-line non-small cell lung cancer across the spectrum of PD-L1 expression and first-line head and neck cancer.

Incyte’s Indoleamine 2,3-dioxygenase 1 (IDO1) is a key immunosuppressive enzyme that modulates the anti-tumor immune response by promoting regulatory T cell generation and blocking effector T cell activation.

Bristol-Myers Squibb’s global development program founded on scientific expertise in the field of Immuno-Oncology includes a broad range of clinical trials studying Opdivo, across all phases, including Phase 3, in a variety of tumor types.

Additionally, the companies are expanding the ECHO-204 Phase 1/2 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 phase 3 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 3 registrational trials,” said Fouad Namouni, M.D., head of Development, Oncology, Bristol-Myers Squibb.

Steven Stein, M.D., Chief Medical Officer, Incyte, said: “We believe that further expanding the ECHO development program for epacadostat, including the initiation of these new Phase 3 trials, will bring us closer to our goal of providing new treatment options for patients with certain cancers.”