Collaboration for late-stage combination trial in first-line kidney cancer

Shares of US biotech firm Exelixis (Nasdaq: EXEL) were up 6.9% at $23.19 in mid-morning trading today after it announced a clinical development collaboration to evaluate Cabometyx (cabozantinib) with Opdivo (nivolumab), Bristol-Myers Squibb’s (NYSE: BMY) PD-1 immune checkpoint inhibitor, 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 (HCC), and potentially other tumor types.

“The safety and efficacy data from the Phase I clinical trial evaluating Cabometyx in combination with Opdivo are consistent with the preclinical scientific rationale for combining these two therapeutic modalities,” said Michael Morrissey, president and chief executive of Exelixis, adding: “This clinical development collaboration will provide the resources and collaborative framework to fully evaluate the potential for this combination, with and without Yervoy, in both late-stage pivotal and exploratory trials in a variety of forms of cancer. We look forward to working with Bristol-Myers Squibb to further understand the role these combination therapies may play in helping patients on a global basis.”