Bristol Myers Squibb (BMY) Receives Positive CHMP Opinion for Opdivo in Combination with Cabometyx as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma

Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo® (nivolumab) in combination with Cabometyx® (cabozantinib) for the first-line treatment of adults with advanced renal cell carcinoma (RCC). The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.

“In recent years, we’ve seen a transformation in the renal cell carcinoma treatment landscape, with numerous advances that have helped improve outcomes for patients,” said Dana Walker, M.D., M.S.C.E., vice president, development program lead, genitourinary cancers, Bristol Myers Squibb. “Bristol Myers Squibb introduced the first immunotherapy combination to patients with renal cell carcinoma in the EU with the approval of Opdivo plus Yervoy, which has shown durable, long-term survival in the pivotal CheckMate -214 trial. Now, with the positive recommendation from the CHMP, we are one step closer to bringing another Opdivo-based regimen that has demonstrated superior efficacy to patients who may benefit from an immunotherapy and tyrosine kinase inhibitor combination.”

The CHMP adopted the positive opinion based on results from the Phase 3 CheckMate -9ER trial, which demonstrated significant and clinically meaningful improvements in progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) compared to sunitinib, with consistent efficacy benefits observed across key subgroups of patients. Opdivo combined with Cabometyx was well tolerated and reflected the known safety profiles of the immunotherapy and tyrosine kinase inhibitor (TKI) components in first-line advanced RCC. The full data from the CheckMate -9ER trial were presented during a Presidential Symposium at the European Society for Medical Oncology Virtual Congress 2020.

The novel combination of Opdivo and Cabometyx was approved by the U.S. Food and Drug Administration (FDA) in January 2021. In addition, Bristol Myers Squibb and its partners have shared the CheckMate -9ER data with regulatory authorities around the world.

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -9ER clinical trial.

About CheckMate -9ER

CheckMate -9ER is an open-label, randomized, multi-national Phase 3 trial evaluating patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). A total of 651 patients (23% favorable risk, 58% intermediate risk, 20% poor risk; 25% PD-L1≥1%) were randomized to receive Opdivo plus Cabometyx (n=323) vs. sunitinib (n=328). The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS) and objective response rate (ORR). The primary efficacy analysis is comparing the doublet combination vs. sunitinib in all randomized patients. The trial is sponsored by Bristol Myers Squibb and Ono Pharmaceutical Co and co-funded by Exelixis, Inc., Ipsen and Takeda Pharmaceutical Company Limited.

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