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MSD’s Keytruda catches up in kidney cancer

Combination therapy approved in EU for all risk groups

Keytruda

MSD’s Keytruda in combination with Inlyta (axitinib) has won European Commission (EC) approval in the first-line treatment of the most common form of kidney cancer – advanced renal cell carcinoma (RCC).

Keytruda is continuing to prove its lead in the anti-PD-1/PD-L1 therapy area, with this approval closely following its FDA approval in advanced RCC earlier this year. The blockbuster drug is approved in a variety of cancer types, with its most notable lead being the lung cancer market. The EC approval is based on the phase 3 KEYNOTE-426 trial, which demonstrated that the Keytruda combination therapy reduced the risk of death by 47% compared with sunitinib, an older drug marketed by Pfizer.

This is an improvement on BMS’ rival therapy Opdivo, which won its approval on the back of the phase 3 CheckMate-214 clinical trial in January.This trial showed that Opdivo in combination with Yervoy (ipilimumab) decreased the risk of death by 37%.

The Keytruda approval also demonstrated an improvement in progression-free survival and objective response rate compared to the standard treatment. It also has another advantage over Opdivo, having been approved for RCC across all International Metastatic RCC Database Consortium (IMDC) risk categories. BMS’ anti-PD-1 therapy is only approved for patients with intermediate- and poor-risk RCC.

“The European approval of Keytruda with axitinib combination for the treatment of advanced RCC marks an important milestone in our efforts for patients with this aggressive disease,” said Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories.

“Offering an additional treatment option in the first-line setting is particularly important in patients with advanced RCC and underscores our commitment to develop Keytruda in areas of unmet need,” he added.

The kidney cancer market is now becoming increasingly competitive, with Keytruda and Opdivo also facing competition from Pfizer/Merck KGaA’s Bavencio (avelumab), which was approved in May. However, Keytruda arguably has the upper hand, with its approval in the lucrative first-line lung cancer indication helping with sales momentum. It is also widely used by oncologists across other indications, which could help it become the preferable choice in RCC too.

Article by
Lucy Parsons

5th September 2019

From: Regulatory

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