Bristol-Myers Squibb and Celgene have established 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).
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. The proprietary name OPDIVO has been proposed in the US and other countries, but remains subject to health authority approval. 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.
Celgene will conduct the study, which is expected to begin in the fourth quarter of 2014. 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.
Source: Bristol-Myers Squibb