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BMS gains FDA approval for second Opdivo combo in kidney cancer

BMS' Opdivo/Yervoy regimen was its first combo to be approved for advanced renal cell carcinoma

The US Food and Drug Administration (FDA) has approved a combination of Bristol Myers Squibb’s (BMS) Opdivo with Exelixis’ Cabometyx in renal cell carcinoma (RCC) – the most common type of kidney cancer.

BMS’ PD-L1 inhibitor Opdivo (nivolumab) is already approved in combination with CTLA-4 inhibitor Yervoy (ipilimumab) as an initial treatment for advanced RCC patients.

The new Opdivo/Cabometyx approval is also for the first-line treatment of patients with advanced RCC.

This approval is based on results from the phase 3 CheckMate-9ER trial, which compared Opdivo plus Cabometyx to Pfizer’s older tyrosine kinase inhibitor (TKI) Sutent (sunitinib) in patients with advanced RCC.

The results from this trial, presented at the 2020 European Society for Medical Oncology (ESMO) virtual congress, detailed a 40% reduction in the risk of death among previously untreated RCC patients receiving the Opdivo/Cabometyx combination compared to Sutent.

The combo also met the primary trial endpoint of achieving a statically significant improvement in progression-free survival (PFS), with Opdivo plus Cabometyx hitting a median PFS of 16.6 months compared to 8.3 months for Sutent.

In addition, the overall response rate (ORR) for Opdivo/Cabometyx-treated patients improved upon that observed in the Sutent arm, with an ORR of 55.7% versus 27.1%, respectively.

“The role of Opdivo plus Yervoy is well established for intermediate/poor-risk patients with advanced RCC, and today’s achievement extends the potential of an Opdivo-based combination to even more patients,” says Adam Lenkowsky, general manager and head, US, oncology, immunology, cardiovascular at BMS.

“Opdivo in combination with Cabometyx brings together the strong heritage of both medicines to provide physicians with a new combination in advanced RCC that may offer improved outcomes to patients for whom an immunotherapy plus tyrosine kinase inhibitor regimen is appropriate,” he added.

Armed with two Opdivo combinations in its arsenal, BMS is primed to take on Merck & Co/MSD’s blockbuster checkpoint inhibitor Keytruda (pembrolizumab) plus Pfizer’s TKI Inlyta (ipilimumab).

Keytruda/Inlyta won an FDA approval in advanced RCC in February 2019, on the strength of data from the phase 3 Keynote-426 trial.

Top-line results from this trial of Keytruda plus Inlyta in first-line RCC showed an overall response rate of 59.3%, alongside a 47% reduction in the risk of death compared to Sutent.

The European Medicines Agency (EMA) has already validated the completion of BMS/Exelixis’ submissions for Opdivo/Cabometyx in RCC, launching the centralised review process of the combination treatment.

Article by
Lucy Parsons

25th January 2021

From: Regulatory



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