Phase I study to evaluate OPDIVO (nivolumab), Bristol-Myers Squibb's investigational PD-1 immune checkpoint inhibitor, with Celgene's ABRAXANE® for multiple cancers
(NEW YORK and SUMMIT, NJ - August 20, 2014) - Bristol-Myers Squibb Company (NYSE: BMY) and Celgene Corporation (Nasdaq: CELG) announced today the establishment of 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. 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). The proprietary name OPDIVO has been proposed in the U.S. and other countries, but remains subject to health authority approval.
OPDIVO 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.
"Bristol-Myers Squibb continues to forge partnerships focused on exploring the effects of combination regimens that utilize promising therapies from our immuno-oncology portfolio," said Michael Giordano, senior vice president, Oncology Development, Bristol-Myers Squibb. "Through this collaboration, Bristol-Myers Squibb and Celgene will work together to advance the science and understanding of how the body's own immune system and chemotherapy might work together to fight cancer."
"Our collaboration with Bristol-Myers Squibb further underscores our commitment to understanding and modulating the immune system to advance the treatment paradigm in cancer," said Markus Renschler, MD, Senior Vice President, Global Head of Hematology & Oncology Medical Affairs, Celgene. "We believe that ABRAXANE is appropriate as a combination partner for novel immuno-oncology therapies due to its proven anti-tumor activity and that it can be administered without steroid premedication."
The study, which is expected to begin in the fourth quarter of 2014, will be conducted by Celgene. Patients with HER-2 negative breast cancer will be treated with ABRAXANE and OPDIVO, patients with NSCLC will be treated with the combination of ABRAXANE, carboplatin and OPDIVO, and patients with pancreatic adenocarcinoma will be treated with ABRAXANE, gemcitabine and OPDIVO. Additional details of the collaboration were not disclosed.
About OPDIVO (nivolumab)
Cancer cells may exploit "regulatory" pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack. OPDIVO is an investigational human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. The company is investigating whether by blocking this pathway, OPDIVO would enable the immune system to resume its ability to recognize, attack and destroy cancer cells.
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 monotherapy or in combination with other therapies - in which more than 7,000 patients have been enrolled worldwide. Among these are several potentially registrational trials in NSCLC, melanoma, renal cell carcinoma (RCC), head and neck cancer, glioblastoma and non-Hodgkin lymphoma. In 2013, the FDA granted Fast Track designation for OPDIVO in NSCLC, melanoma and RCC. 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, Ono Pharmaceutical Co. announced that OPDIVO received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma, making OPDIVO the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world.
ABRAXANE is an albumin-bound form of paclitaxel that is manufactured using patented nab® technology. ABRAXANE is formulated with albumin, a human protein, and is free of solvents.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visitwww.celgene.com. Follow us on Twitter @Celgene as well.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that nivolumab will receive regulatory approval in the U.S. either as a single agent or in a combination regimen, or, if approved, that it will become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2013 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Celgene Forward-Looking Statement
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