Exelixis and BMS start Phase III combination trial for renal cell carcinoma

Exelixis and Bristol-Myers Squibb (BMS) have started the Phase III CheckMate 9ER clinical trial of Cabometyx (cabozantinib) combined with Opdivo (nivolumab) or both Opdivo and Yervoy (ipilimumab) to treat renal cell carcinoma (RCC).

Available in 20mg, 40mg and 60mg doses, Cabometyx is a small molecule inhibitor designed to target receptor tyrosine kinases such as MET, AXL and VEGFR-1, VEGFR-2 and VEGFR-3, while Opdivo is an immune checkpoint inhibitor of programmed death-1 (PD-1).

The open-label, randomised, multi-national Phase III CheckMate 9ER trial will compare the investigational combinations with sunitinib in 1,014 previously untreated advanced or metastatic RCC patients.

Exelixis product development and medical affairs president and chief medical officer Gisela Schwab said: “There is strong scientific evidence showing that Cabometyx results in a more immune permissive tumour environment, and we are eager to determine if combining these active agents with complementary and potentially cooperative mechanisms of action has the potential to further improve patient outcomes.”

The trial’s primary endpoint is progression-free survival (PFS), while its primary efficacy analysis is comparison of the combinations in intermediate or poor-risk patients.

Bristol-Myers Squibb oncology development head Fouad Namouni said: “Combination therapy with agents that target different and complementary pathways, in this case, the combination of immune checkpoint inhibitors and tyrosine kinase inhibitors, may be a potential new approach for these patients.”

Cabozantinib was approved by the US Food and Drug Administration in April last year for the treatment of advanced RCC in patients previously receiving anti-angiogenic therapy, and by the European Commission in September last year for use in the European Union, Norway and Iceland.

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Image: Micrograph of renal cell carcinoma. Photo: courtesy of Nephron.