Exelixis, BMS collaborate on late-stage combination trial in first-line RCC

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Exelixis Inc. and Bristol-Myers Squibb Co. entered into a clinical development collaboration to evaluate Cabometyx (cabozantinib), Exelixis’ small molecule inhibitor of receptor tyrosine kinases, with BMS’s Opdivo (nivolumab), either alone or in combination with Yervoy (ipilimumab).

The clinical development program, which will be co-funded by the companies, is expected to include a phase III pivotal trial in first-line renal cell carcinoma, with additional trials planned in bladder cancer, hepatocellular carcinoma, and potentially other tumor types.

Cabometyx and Opdivo have both received approval in the U.S, and E.U. for specific uses in previously treated renal cell carcinoma, and both compounds are the subject of ongoing, global phase III pivotal trials in hepatocellular carcinoma. Opdivo is approved in the United States for previously treated bladder cancer.

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