Opdivo plus Cabometyx approved in the EU for advanced renal cancer

The European Commission (EC) has authorised Bristol Myers Squibb’s (BMS) Opdivo plus Ipsen’s Cabometyx as a first-line treatment for advanced renal cell carcinoma (aRCC).

The EU approval is based on results from the Phase III CheckMate-9ER trial, which evaluated Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) in previously untreated advanced or metastatic renal cell carcinoma patients.

In this study, Opdivo plus Cabometyx doubled progression-free survival compared to patients receiving Pfizer's tyrosine kinase inhibitor (TKI) Sutent (sunitinib) alone – 16.6 months versus 8.3 months respectively.

The Opdivo and Cabometyx combination also reduced the risk of death by 40% compared to the TKI inhibitor, and also demonstrated a superior objective response rate (ORR) – twice as many patients responded to BMS/Ipsen’s drugs compared to Sutent.

“Today’s EC approval for the use of Cabometyx in combination with Opdivo provides an important new first-line treatment option for patients living with advanced renal cell carcinoma,” said Howard Mayer, executive vice president and head of research and development, Ipsen.

“We look forward to collaborating with a broad range of European stakeholders to bring this unique combination to eligible patients living with advanced renal cell carcinoma,” he added.