Bristol-Myers Squibb Company and Incyte Corporation 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, nivolumab, and Incyte’s oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360, in a Phase I/II study. Multiple tumor types will be explored in the study, which could potentially include melanoma, non-small cell lung (NSCLC), ovarian, colorectal (CRC), squamous cell carcinoma of the head and neck (SCCHN) and diffuse large B-cell lymphoma (DLBCL).
Nivolumab and INCB24360 are 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. Nivolumab and INCB24360 target distinct regulatory components of the immune system, and there is preclinical evidence suggesting that the combination of these two agents may lead to an enhanced anti-tumor immune response compared to either agent alone.
“Bristol-Myers Squibb is committed to pursuing the full potential of its immuno-oncology portfolio through the study of promising approaches to combination regimens,” stated Michael Giordano, senior vice president, Oncology and Immunosciences Development. “Given the encouraging data for Incyte’s IDO1 inhibitor and our current understanding of nivolumab’s anti-tumor immune response, we see this as an important area of study to add to our broad clinical development program.”
“The field of immunotherapy has the potential to transform the treatment of many cancers and significantly improve patient outcomes,” stated Hervé Hoppenot, President and Chief Executive Officer of Incyte. “Given the synergistic activity we have seen with our IDO1 inhibitor when combined with checkpoint inhibitors in preclinical models, and based on our emerging clinical data, we look forward to collaborating with Bristol-Myers Squibb to explore this combination across a wide range of tumor types.”
The study, which is expected to begin in the fourth quarter of 2014, will be co-funded by the companies and conducted by Incyte. Additional details of the collaboration were not disclosed.