Opdivo Plus Cabometyx Combination Receives FDA Priority Review for First-Line Treatment of Advanced Renal Cell Carcinoma, Demonstrating 40% Reduction in Death Risk

Today, Bristol-Myers Squibb (BMS) and Exelixis announced that the U.S. FDA has accepted for review the supplemental Biologics License Application (sBLA) and the supplemental New Drug Application (sNDA), respectively, for Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) for the treatment of patients with advanced renal cell carcinoma (RCC). The FDA has also granted Priority Review to both applications, with action dates expected by February 20, 2021.

Globally, approximately 71,000 patients will require systemic therapy for advanced renal cell carcinoma (RCC) in 2020. If detected at an early stage, RCC has a high five-year survival rate; however, for patients with advanced or metastatic RCC, the five-year survival rate is only 12%.

Clear cell RCC is the most common type of kidney cancer in adults. Histologically, approximately 70% of RCC cases are clear cell RCC. In most clear cell RCC tumors, levels of a protein called von Hippel-Lindau are lower than normal, leading to elevated levels of MET, AXL, and VEGF. These proteins promote tumor angiogenesis, growth, invasion, and metastasis. MET and AXL may drive tumor resistance to VEGF receptor inhibitors.

Opdivo is a blockbuster PD-1 inhibitor developed by Bristol-Myers Squibb Company, while Cabometyx (cabozantinib) is a tyrosine kinase inhibitor developed by Exelixis that inhibits VEGFR-1/2/3, KIT, TRKB, FLT-3, AXL, RET, MET, and TIE-2. Both have received FDA approval as monotherapies for the treatment of patients with advanced renal cell carcinoma (RCC).

These two applications are based on the results of the Phase 3 clinical trial CheckMate-9ER. This clinical trial evaluated the efficacy and safety of Opdivo in combination with Cabometyx as first-line treatment for patients with advanced renal cell carcinoma (RCC). The trial results demonstrated that, compared to the active control group, the Opdivo/Cabometyx combination therapy reduced the risk of death by 40% (HR=0.60, 98.89% CI, 0.40–0.89, p=0.0010). It also doubled the progression-free survival (PFS), with a PFS of 16.6 months in patients receiving the combination therapy versus 8.3 months in the active control group.

References:

[1] U.S. Food and Drug Administration Accepts for Priority Review Applications for OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib) in Advanced Renal Cell Carcinoma. Retrieved October 19, 2020, from https://www.businesswire.com/news/home/20201019005198/en

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