On July 31, 2017 Bristol-Myers Squibb Company (NYSE:BMY) and Clovis Oncology, Inc. (Nasdaq:CLVS) reported 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 in pivotal phase 3 clinical trials in: Schedule your 30 min Free 1stOncology Demo! 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 (Press release, Bristol-Myers Squibb, JUL 31, 2017, View Source [SID1234519938]).
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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 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 (HRD), 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 percentage of tumor genome with LOH, a phenotypic consequence of HRD. 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. 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.
"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," said Patrick J. Mahaffy, President, and CEO of Clovis Oncology. "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."
"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, M.D., head of Oncology Development, Bristol-Myers Squibb. "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 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.
About Ovarian Cancer
According to the World Cancer Research Fund International, ovarian cancer is the seventh most common cancer in women worldwide (18th most common cancer overall), with 239,000 new cases diagnosed in 2012. There are often no specific initial symptoms, and in an estimated 80 to 85% of ovarian cancer cases, the cancer has spread to other parts of the body before a person is diagnosed and can be treated. Ovarian cancer ranks fifth in cancer deaths in the U.S. and causes more deaths than any other cancer of the female reproductive system.
About Triple-Negative Breast Cancer
Breast cancer is the most frequently diagnosed cancer in women worldwide with nearly 1.7 million new cases diagnosed in 2012, accounting for 25% of all new cancer cases in women according to the International Agency for the Research of Cancer (IARC) of the World Health Organization. More than one out of every 10 breast cancers are found to be triple-negative, meaning the cancer does not have the biomarkers that predict response to hormonal therapy or therapies that target HER2 receptors. Triple negative tumors are often aggressive and have a poorer prognosis compared to hormone receptor-positive breast cancers.
About Castration-Resistant Prostate Cancer
Prostate cancer is the second most frequently diagnosed cancer in men, with 1.1 million new cases diagnosed worldwide in 2012. Unlike many early-stage prostate cancers that need normal levels of testosterone to grow, castration-resistant prostate cancer (CRPC) continues to grow even when the amount of testosterone in the body is reduced to castrate levels. CRPC patients have a very high likelihood of having or developing metastases, meaning the cancer has spread to other areas of the body. While the 5-year survival rate for most stages of prostate cancer is almost 100%; the 5-year survival rate for prostate cancer that has spread to distant lymph nodes, bones, or other organs is approximately 29%.