Therapy Areas: AIDS & HIV
Bristol-Myers Squibb and Clovis Oncology Partner to Evaluate Combination of Opdivo and Rubraca in Multiple Tumor Types
1 August 2017 - - New York, New York-based biopharmaceutical company Bristol-Myers Squibb (NYSE: BMY) and Boulder, Colorado-based anti-cancer agent specialist Clovis Oncology, Inc. (NASDAQ: CLVS) 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 inhibitor Rubraca in pivotal phase 3 clinical trials in advanced ovarian cancer and advanced triple-negative breast cancers (TNBC), the companies said.
The collaboration will also include a Phase 2 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.
Rubraca is an oral, small molecule inhibitor of PARP enzymes, including PARP-1, PARP-2, and PARP-3, being developed for the treatment of solid tumors associated with homologous recombination deficiency, defined as the presence of a deleterious BRCA1 or BRCA2 mutation, a deleterious mutation in another gene involved in DNA damage repair, and/or a high %age of tumor genome with LOH, a phenotypic consequence of HRD. 
Opdivo is a human programmed death receptor-1 blocking antibody that binds to the PD-1 receptor expressed on activated T-cells and other immune cells.
The overlap in immuno-biology linked to these agents supports the potential for synergy of PARP inhibition and PD-1 blockade.
Preclinical evidence has demonstrated that PARP inhibition can trigger inflammation, cell death and increase T-cell infiltration within tumors.
The planned multi-arm clinical trials will be conducted in the US, 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.
Bristol-Myers Squibb Company discovers, develops, licenses, manufactures, markets, and distributes biopharmaceutical products worldwide.
The company offers chemically-synthesized drug and biologic in various therapeutic areas, such as oncology; cardiovascular; immunoscience; and virology comprising human immunodeficiency virus infection (HIV).
Clovis Oncology, a biopharmaceutical company, focuses on acquiring, developing, and commercializing anti-cancer agents in the United States, Europe, and internationally.
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