EC Approves BMS’ Opdivo in Combination with Cabometyx for Advanced RCC

Pharmaceutical Technology Editors

BMS has announced that the EC has approved Opdivo in combination with Cabometyx for the first-line treatment of adults with advanced renal cell carcinoma.

Bristol Myers Squibb (BMS) has announced, in an April 14, 2021 press release, that the European Commission (EC) has approved Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) for the first-line treatment of adults with advanced renal cell carcinoma (RCC).

EC’s decision was based on Phase III trial results demonstrating superior efficacy of the combination treatment versus sunitinib in progression-free survival, objective response rate, and overall survival. Additionally, the combination treatment was found to be well-tolerated with a low rate of treatment related adverse events leading to discontinuation.

“With this approval, we can now offer patients two different Opdivo-based combinations that have demonstrated significant survival benefits versus sunitinib,” said Dana Walker, vice-president, development program lead, genitourinary cancers, BMS, in the press release. “Today’s milestone builds on our heritage of developing and delivering novel treatments for patients with advanced RCC, first with the only dual immunotherapy option, Opdivo plus Yervoy, and now with a new immunotherapy and tyrosine kinase inhibitor regimen.”

“The combination of nivolumab and cabozantinib pairs two proven agents for advanced RCC that together have shown superior efficacy across key endpoints and subgroups of patients compared to sunitinib in the CheckMate -9ER trial. Additionally, the combination’s safety profile was manageable with known protocols, leading to a low rate of treatment-related discontinuations,” added Marc-Oliver Grimm, professor of medicine and urology department head, Jena University Hospital, in the press release. “With today’s approval, clinicians in the EU will be able to offer patients with advanced RCC an additional combination therapy that may help them achieve early control of their disease and improve survival outcomes.”

The European approval is for a flexible dosing regimen of the combination therapy—either using Opdivo 240 mg intravenously every two-weeks or 480 mg intravenously every four-weeks in combination with Cabometyx 40 mg, administered orally once a day. The combination therapy was approved by the US FDA in January 2021, further applications are under review with other regulatory bodies worldwide.

Source: BMS