Additional Studies of Opdivo (nivolumab) in Combination with Rubraca in Prostate Cancer and Other Applications of Opdivo.

Editorial note: I am writing some of this post while awaiting Hurricane Irma to pass my home directly in about 1-2 hours.

Opdivo® (nivolumab) and the prostate cancer vaccine Prostvac are being combined in a National Cancer Institute clinical trial described in posts on this website dated May 15th and August 7th, 2017. Bristol Myers Squibb and Clovis Technology will collaborate to assess the combination of Opdivo® (nivolumab) and the PARP inhibitor, Rubraca (rucaparib) in Phase 2 and 3 clinical studies in patients with different cancer types, including prostate cancer.

The companies plan to launch a Phase 2 study to investigate the safety and effectiveness of the combination treatment in patients with metastatic castration-resistant prostate cancer (mCRPC). All studies are expected to begin before the end of 2017.

“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,” according to Patrick J. Mahaffy, Clovis Oncology’s president and CEO. “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,” he said.

Cancer cells are constantly multiplying, but the division process is sometimes associated with errors that may cause their death, such as DNA breaks. If cancer cells repair these breaks, they survive and keep multiplying.

Rubraca is an oral inhibitor of PARP proteins (PARP-1, PARP-2, and PARP-3), which are involved in DNA repair. By inhibiting these proteins, Rubraca prevents cancer cells to repair their DNA. Indeed, previous studies have shown that PARP inhibition promotes inflammation, cell death, and increases the action of T-cells within tumors.

Opdivo® acts upon a protein called programmed cell death-1 (PD-1), which inhibits the immune system’s ability to detect cancer cells. By inhibiting PD-1, Opdivo® restores the body’s capacity to activate the anti-tumor response and fight cancer cells. Because of its potential role as an enhancer of the immune system’s response, Opdivo® is under evaluation in a broad range of clinical trials across all phases in a variety of tumor types. For more information, see the following.

Additional results involving Opdivo® include an article published September 11th in MedlinePlus describing research suggesting that Opdivo® — a drug that works with the immune system to fight melanoma — is more effective than the current standard of care for patients who’ve had surgery to remove advanced tumors. In addition, an August 17th post from the National Cancer Institute Current Contents stated that the Food and Drug Administration has approved Opdivo® for patients with metastatic colorectal cancer that has one of two specific genetic features and whose disease has progressed after chemotherapy.

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