A new clinical collaboration has been established between Bristol-Myers Squibb (BMS) and Clovis Oncology to evaluate the performance of Opdivo (nivolumab) in combination with Rubraca (rucaparib) in a Phase 3 trial for advanced ovarian cancer.
Additional clinical trials testing the combination therapy will include patients with triple-negative breast cancer and metastatic prostate cancer.
The pivotal Phase 3 trial will evaluate three lines of treatment as first-line maintenance therapy in patients with stage 3/4 high-grade ovarian, fallopian tube, or primary peritoneal cancer who have completed platinum-based chemotherapy.
Specifically, researchers will evaluate the action of Rubraca and Opdivo each delivered as a monotherapy, and as a combination of both drugs. The study will also include a control group, where patients will be given a placebo.
Opdivo is an immunotherapy drug that binds and blocks the PD-1 protein, expressed at the surface of key cells of our immune system. Activating PD-1 through its binding partner, PD-L1, works as a type of “off switch,” shutting down immune cells. Antibodies targeting PD-1 or PD-L1, such as Opdivo, boost the immune response against cancer cells.
Rubraca is a small molecule inhibitor of PARP enzymes, making it difficult for tumor cells to repair its DNA, a key step in their survival. Preclinical studies have also suggested that PARP inhibition impacts the immune system’s response against tumors, as shown by an increase of infiltrating T-cells into tumors. These results suggest that PARP inhibition and PD-1 blockade could potentially work in synergy.
The combination of Rubraca and Opdivo will also be tested in another Phase 3 trial in patients with locally advanced, inoperable triple-negative breast cancer associated with an homologous recombination deficiency (HRD).
In addition, a Phase 2 study will be testing the combo therapy in patients with metastatic castration-resistant prostate cancer (mCRPC).
“We are very enthusiastic about studying Rubraca and Opdivo in combination, and the potential to create new treatment options for patients with multiple tumor types, as well as for patients beyond those with BRCA mutations,” Patrick J. Mahaffy, president and CEO of Clovis Oncology, said in a press release. “This substantial clinical collaboration in ovarian, triple-negative breast, and prostate cancers represents a significant effort by Clovis and Bristol-Myers Squibb to realize that potential.”
Bristol-Myers Squibb agreed.
“This clinical collaboration addresses areas of unmet medical need where the combination of Opdivo and Rubraca may lead to an additional treatment option for patients with difficult to treat cancers,” said Fouad Namouni, MD, head of the Oncology Development at BMS. “We are committed to investigating a wide range of oncology therapies and look forward to studying the combination of Clovis’ PARP inhibitor and our immunotherapy.”
The trials will include centers in the U.S. and Europe, with additional countries likely to join. Clovis and BMS are the studies’ sponsors, with Clovis conducting the ovarian cancer rial and Bristol-Myers Squibb the breast and prostate cancer studies. The trials are scheduled to begin this year.
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