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European Commission approves Opdivo plus Cambometyx for advanced kidney cancer

Checkpoint inhibitor plus tyrosine kinase inhibitor approved for the first-line treatment of advanced renal cell carcinoma

The European Commission (EC) has approved a combination of Bristol Myers Squibb’s (BMS) Opdivo with Ipsen’s Cabometyx for the first-line treatment of advanced renal cell carcinoma (RCC) – the most common form of kidney cancer.

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

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

The results from this trial demonstrated a 40% reduction in the risk of death among previously untreated RCC patients receiving the Opdivo plus Cabometyx combination compared to Sutent.

Opdivo plus Cabometyx also hit the primary endpoints of achieving a statistically significant improvement in progression-free survival (PFS) – the Opdivo/Cabometyx regimen had a median PFS of 16.6 months compared to 8.3 months for Sutent.

Twice as many patients responded to Opdivo plus Cabometyx compared to Sutent – 55.7% and 27.1%, respectively.

A new, updated analysis conducted with at least 16.0 months follow-up showed that the Opdivo plus Cabometyx combination continued to demonstrate superior progression-free survival (PFS), objective response rate (ORR) and overall survival (OS) compared to Sutent.

BMS/Exelixis’ combination treatment doubled median PFS compared to Sutent, and also demonstrated a 34% reduction in the risk of death compared to Pfizer’s drug.

Opdivo/Cabometyx was also associated with a disease control rate of 88.2% versus 69.9% with Sutent.

An exploratory subgroup analysis of 75 patients with sarcomatoid features also showed that the combination of Opdivo/Cabometyx had a benefit in this population, with a reduction in the risk of death of 64% compared to Sutent.

Opdivo/Cabometyx also demonstrated superior PFS (10.3 months versus 4.2 months) and ORR (55.9% versus 22%) in these patients compared to Sutent.

RCC with sarcomatoid differentiation is a highly aggressive form of the disease, and is typically associated with a particularly poor prognosis.

“Today's milestone builds on our heritage of developing and delivering novel treatments for patients with advanced renal cell carcinoma, first with the only dual immunotherapy option, Opdivo plus Yervoy, and now with a new immunotherapy and tyrosine kinase inhibitor regimen,” said Dana Walker, vice president, development programme lead, genitourinary cancers, BMS.

“We look forward to working with a broad range of European stakeholders to bring Opdivo in combination with Cabometyx to patients who may benefit from this treatment,” she added.

Article by
Lucy Parsons

15th April 2021

From: Regulatory



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