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Merck KGaA, Pfizer’s Bavencio stumbles in head and neck cancer

Checkpoint inhibitor unlikely to improve progression-free survival

Merck KGaA

Merck KGaA and Pfizer have hit a bump in the road in their efforts to extend the reach of Bavencio, their late-comer PD-L1 inhibitor – this time stumbling in head and neck cancer.

The partners had been testing Bavencio (avelumab) in untreated, advanced squamous cell carcinoma of the head and neck. In the phase 3 JAVELIN trial, Bavencio was being evaluated in combination with chemoradiotherapy (CRT), versus standard of care CRT.

The trial has been halted based on the recommendation of an independent data monitoring committee, after finding the drug was unlikely to reach a statistically significant improvement in the primary endpoint – in this case, progression-free survival.

According to Pfizer, head and neck cancer is the sixth most common cancer in the world, with approximately 60% of people diagnosed at the locally advanced stage.

The fail in this indication is another blow to a drug that has been struggling to make a space for itself in a crowded market, with a new generation of PD-1/PD-L1 inhibitors spilling across a number of cancer types and ramping up the competition.

Bavencio was fourth to market in the checkpoint inhibitor category, and has been tailing behind market leaders since its launch – namely Merck & Co’s Keytruda (pembrolizumab) and Bristol-Myers Squibb’s Opdivo (nivolumab).

It had carved a niche in second-line bladder cancer after picking up approval in 2018, but is now competing with a number of other cancer immunotherapies, including the aforementioned from Merck & Co and BMS.

Merck KGaA/Pfizer’s drug then picked up an approval in first-line, advanced renal cell carcinoma (RCC) last year, the most common form of kidney cancer.

However, Bavencio lagged behind Keytruda even in that indication, after Merck & Co’s PD-1 inhibitor beat it to the punch after winning approval in RCC a few months earlier.

Despite the competition, kidney cancer is a large market with over 70,000 new cases in the US every year, meaning there is at least room for a range of therapies in this indication.

Although Merck KGaA/Pfizer have suffered a setback in head and neck cancer, the partners are still planning to go forward with additional testing of Bavencio in this indiction, in combination with different immuno-oncololgy therapies in the phase 2 JAVELIN Medley trial.

Detailed analysis of the late-stage JAVELIN trial is yet to be released, but the partners say when the information is available they will share it with the ‘scientific community’.

Article by
Lucy Parsons

16th March 2020

From: Research

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