BMS and Clovis Oncology to collaborate with Opdivo (nivolumab) and Rubraca (rucaparib) in trials for ovarian cancer, triple negative breast cancer and prostate cancer .

Bristol-Myers Squibb Company and Clovis Oncology, Inc. announced the companies have entered into a clinical collaboration agreement to evaluate the combination of Bristol-Myers Squibb’s immunotherapy Opdivo and Clovis Oncology’s poly (ADP-ribose) polymerase (PARP) inhibitor Rubraca (rucaparib) in pivotal phase III clinical trials in: Advanced ovarian cancer: First-line maintenance treatment study to evaluate Rubraca + Opdivo, Rubraca, Opdivo and placebo in newly diagnosed patients with stage III/IV high-grade ovarian, fallopian tube or primary peritoneal cancer who have completed platinum-based chemotherapy. Advanced triple-negative breast cancers (TNBC): First-line maintenance treatment study to evaluate Rubraca + Opdivo, Rubraca, Opdivo and chemotherapy in patients with stage IV or recurrent locally advanced inoperable TNBC associated with a homologous recombination deficiency (HRD).

The collaboration will also include a Phase II study to evaluate the safety and efficacy of Opdivo in combination with Rubraca in patients with metastatic castration-resistant prostate cancer (mCRPC). The Opdivo + Rubraca combination in mCRPC will be conducted as an arm of a larger Bristol-Myers Squibb-sponsored study.

The planned multi-arm clinical trials will be conducted in the U.S., Europe and possibly additional countries. Clovis will be the study sponsor and conducting party for the ovarian cancer study and Bristol-Myers Squibb will be the study sponsor and conducting party for the breast and prostate cancer studies. Specific terms of the agreement were not disclosed. All three studies are expected to begin before the end of 2017.

Comment: Merck Inc., has bought an interest in a collaboration for AstraZeneca’s PARP inhibitor Lynparza (olaparib), a major competitor to Rubraca and paid $1.6 billion up front,plus other payments if certain milestones are met.