Phase 3 Trial of Opdivo in Combination with CABOMETYX or Opdivo and Yervoy in Combination with CABOMETYX, Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

(TRUCKEE, CA)-UroToday—Exelixis, Inc. and Bristol-Myers Squibb Company  announced the initiation of the phase 3 CheckMate 9ER trial to evaluate Opdivo® (nivolumab) in combination with CABOMETYX™ (cabozantinib) tablets, a small molecule inhibitor of receptor tyrosine kinases, or Opdivo and Yervoy® (ipilimumab) in combination with CABOMETYX versus sunitinib in patients with previously untreated, advanced or metastatic renal cell carcinoma (RCC). The primary endpoint for the trial is progression-free survival (PFS).

“There is strong scientific evidence showing that CABOMETYX results in a more immune permissive tumor 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,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “We are excited to initiate this first clinical trial from our broad development program with Bristol-Myers Squibb looking at the potential of Opdivo in combination with CABOMETYX, with or without Yervoy, in a variety of tumor types.”

“While existing therapies have improved outcomes for some patients with advanced or metastatic kidney cancer, high rates of relapse and disease progression demonstrate a need for additional therapeutic options, especially among poor and intermediate risk patients,” said Fouad Namouni, M.D., Head of Development, Oncology, Bristol-Myers Squibb. “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.”

CheckMate 9ER is an open-label, randomized, multi-national phase 3 trial that aims to enroll approximately 1,014 patients with previously untreated advanced or metastatic RCC. Patients will be randomized 1:1:1 to one of three arms: CABOMETYX and Opdivo; CABOMETYX, Opdivo and Yervoy; or sunitinib. The primary efficacy analysis will compare the doublet combination versus sunitinib and the triplet combination versus sunitinib in intermediate/poor risk patients with RCC.