Bristol-Myers Squibb Company  and Celgene Corporation have formed a clinical trial collaboration to evaluate the safety, tolerability and, preliminary efficacy of a combination regimen of Bristol-Myers Squibb's investigational PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), and Celgene's nab technology-based chemotherapy, Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), in a Phase I study.

The study, which is expected to begin in the fourth quarter of 2014, will be conducted by Celgene. Multiple tumor types will be explored in the study, including HER-2 negative metastatic breast cancer, pancreatic cancer, and non-small cell lung cancer (NSCLC).

Opdivo (the proprietary name Opdivo has been proposed in the US and other countries, but remains subject to health authority approval) is part of a new class of cancer treatments known as immunotherapies that are designed to harness the body's own immune system in fighting cancer. Opdivo targets distinct regulatory components of the immune system while Abraxane works by interfering with the ability of cancer cells to divide. By combining an immunotherapy with a standard chemotherapy, the companies will explore whether these two agents may lead to an enhanced anti-tumor response compared to either agent alone.

Opdivo was approved in Japan on July 4, 2014 for the treatment of patients with unresectable melanoma and is studied in multiple tumor types consisting of more than 35 trials as a monotherapy or in combination with other therapies. In 2013, the FDA granted Fast Track designation for Opdivo in NSCLC, melanoma, and renal cell carcinoma. In May 2014, the FDA granted Opdivo Breakthrough Therapy Designation for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab. On July 4, 2014 Ono Pharmaceutical Co. announced that Opdivo received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma. Abraxane is an albumin-bound form of paclitaxel that is manufactured using patented nab technology.

Source: Bristol-Myers Squibb