Bristol-Myers Squibb and Clovis Oncology, a Boulder, Colorado-based biopharmaceutical company, have formed a clinical collaboration to evaluate the combination of Bristol-Myers Squibb’s immunotherapy, Opdivo (nivolumab), and Clovis Oncology’s poly (ADP-ribose) polymerase (PARP) inhibitor, Rubraca (rucaparib), in Phase III clinical trials for treating advanced ovarian cancer and advanced triple-negative breast cancers (TNBC).

Opdivo is a human programmed death receptor-1 (PD-1) blocking antibody that binds to the PD-1 receptor expressed on activated T-cells and other immune cells. Rubraca is an oral, small-molecule inhibitor of PARP enzymes, including PARP-1, PARP-2, and PARP-3. It is being developed treating solid tumors associated with homologous recombination deficiency (HRD). The overlap in immuno-biology linked to these agents supports the potential for synergy of PARP inhibition and PD-1 blockade, according to Bristol-Myers Squibb. Preclinical evidence has demonstrated that PARP inhibition can trigger inflammation and cell death and increase T-cell infiltration within tumors.

The collaboration will include three clinical trials: (1) a first-line maintenance treatment study to evaluate Rubraca and 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; (2) a first-line maintenance treatment study to evaluate Rubraca and Opdivo, Rubraca, Opdivo, and chemotherapy in patients with Stage IV or recurrent locally advanced inoperable TNBC associated with a HRD; and (3) 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 and Rubraca combination in mCRPC will be conducted as an arm of a larger Bristol-Myers Squibb-sponsored study.

Source: Bristol-Myers Squibb