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Merck’s Keytruda trial stopped early after beating BMS’ Yervoy on survival

pharmafile | March 25, 2015 | News story | Research and Development, Sales and Marketing BMS, Merck, Yervoy, ipilimumab, keytruda, pembrolizumab 

A trial comparing two potential blockbuster cancer treatments has been stopped early, after Merck’s Keytruda beat BMS’ Yervoy in a survival comparison.

The study’s monitoring committee decided to halt the KEYNOTE-006 study after Keytruda (pembrolizumab) performed better than Yervoy (ipilimumab) in improving overall and progression-free survival when used as a first-line treatment of patients with advanced melanoma.

In a statement Merck says Keytruda “demonstrated a statistically significant and clinically meaningful improvement in overall survival and progression-free survival” compared to Yervoy.

The results, which will be published in full at the American Association of Cancer Research conference in Philadelphia in April, “will help to define the appropriate treatment of advanced melanoma”, says Dr Roger Perlmutter, president of Merck Research Laboratories.

Keytruda is the first of this new class of immuno-oncology treatments known as anti-PD-1 therapies to demonstrate a survival advantage in a head-to-head comparison of the two drugs, which are predicted to reach $33 billion in sales by 2022.

Being given the nod as a first line treatment could lead to a bigger market for Merck. Keytruda is approved in the US for people with advanced melanoma who have previously been treated with Yervoy and treatments called BRAF inhibitors – in people with certain kinds of skin cancers.

In the UK Keytruda has become the first treatment to be signed-off for use through the Early Access to Medicines Scheme.

Impressive data from first-line studies has already swayed regulators to expand indications for anti-PD1 drugs. Recently the FDA approved Opdivo as a first-line treatment for one of the most common forms of lung cancer in record time, and credited strong overall survival data from first-line treatment studies as one of the contributing factors.

Lilian Anekwe 

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