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BMS, Incyte to evaluate combination regimen of two new immunotherapies for multiple cancers

Bristol-Myers Squibb (BMS) and Incyte have entered into a clinical trial collaboration to assess the safety, tolerability and preliminary efficacy of a combination regimen of two novel immunotherapies for multiple cancers.

The evaluation of BMS’ investigational PD-1 immune checkpoint inhibitor, nivolumab, and Incyte’s oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360, will be done in a Phase I/II trial.

Multiple tumor types will be explored in the trial, 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 called as immunotherapies that are designed to harness the body’s own immune system to combat cancer.

Both the agents 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.

BMS senior vice president of Oncology and Immunosciences Development Michael Giordano said the company is committed to pursuing the full potential of its immuno-oncology portfolio through the study of promising approaches to combination regimens.

"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," Giordano said.

The Phase I/II trial, scheduled to begin in the fourth quarter of 2014, will be co-funded by the companies and conducted by Incyte.