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.
Kromek collaborates on next-gen CT detector technology
Gilead Sciences initiates Phase 2 trial in Europe to evaluate lenacapavir for HIV prevention
European Commission grants authorisation to ViiV Healthcare's Apretude for prevention of HIV
Celanese to supply VitalDose drug delivery platform for Population Council's MPT Intravaginal Ring
Henry Schein introduces equipment repair subscription - Henry Schein Thrive Service Plus
Seres Therapeutics provides business updates and reports Q2 2023 financial results