BMS And Celgene Collaborate For Combination Cancer Treatment Study

By Lori Clapper

Bristol-Myers Squibb Company (BMS) and Celgene Corporation announced Wednesday that they are collaborating on a Phase I clinical study, which will determine the 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). The collaborating parties will study multiple types of tumors, including HER-2 negative metastatic breast cancer, pancreatic cancer, and nonsmall cell lung cancer (NSCLC).

Although the proprietary name is still pending approval from health regulators, OPDIVO is an immunotherapy treatment designed to use a body’s own immune system to fight off cancer cells. While Opdivo targets regulatory components of the immune system, Abraxane interferes with the cancer cells’ ability to divide. The two companies hope to find that the combination of these agents will be more powerful together than when taken separately to slow tumor growth.

Celgene expects to conduct the study at the end of 2014, in which participants will be treated as follows:

• HER-2 negative breast cancer patients will be treated with both Abraxane and Opdivo.
• Patients with NSCLC will be treated with the combination of Abraxane, carboplatin, and Opdivo.
• Participants with pancreatic adenocarcinoma will be treated with Abraxane, gemcitabine, and Opdivo.

Other uses have not yet been disclosed.

BMS has begun to explore more combination therapies that could enhance its immuno-oncology portfolio, including another recent partnership with Ono Pharmaceuticals, which was announced last month.

Michael Giordano, SVP, Oncology Development for BMS added that through this partnership, BMS 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,” Markus Renschler, MD, Senior Vice President, Global Head of Hematology & Oncology Medical Affairs, Celgene, said. “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.”

In July, Opdivo was approved for use in Japan as a treatment for unresectable melanoma. In addition, it is currently being studied in multiple tumor types as a monotherapy or in combination with other drugs in more than 35 trials.