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Merck seeks new Keytruda indication in US

pharmafile | April 20, 2015 | News story | Sales and Marketing Cancer, FDA, NSCLC, PD-L1, US, keytruda, lung, pembrolizumab 

Merck is seeking FDA approval for its successful melanoma drug Keytruda to be used treating lung cancer.

The Supplemental Biologics License Application (sBLA) is for the use of Keytruda (pembrolizumab) – an anti-PD1 (programmed death 1) therapy – in advanced non-small cell lung cancer (NSCLC). The drug previously received breakthrough therapy designation for this area in October last year.

The submission is based on data from its KEYNOTE-001 study, which found an overall response rate of 45% in patients with more than 50% of their tumour cells positive for expression of PD-L1 (programmed death-ligand 1 protein), and 19% in the whole study population.

“The results from this study indicate that tumor PD-L1 expression may be a relevant biomarker to identify patients more likely to have higher rates of response to Keytruda in this tumor type,” says Dr Roger Perlmutter, president of Merck Research Laboratories.

The treatment works by making cancer cells ‘visible’ to the immune system so they can be destroyed by the body’s natural defence mechanisms.

Other early trial results presented this week suggest that Keytruda has a response rate of 28% in patients with advanced pleural mesothelioma – a cancer of the lining of the lungs, abdomen and other organs – whose tumours expressed PD-L1.

In March it became the first drug to be approved through the UK’s new Early Access to Medicines Scheme (EAMS), which aims to give people with life threatening or seriously debilitating conditions access to medicines that do not yet have marketing authorisation.

Later that month the Phase III trial comparing the drug to Bristol Myers-Squibb’s Yervoy (ipilimumab) was stopped early after Keytruda beat BMS’ treatment on overall and progression-free survival.

Merck is also testing the drug in combination with Eisai’s Lenvima (lenvatinib mesylate) and Halaven (ribulin mesylate) and the investigational compound entinostat, from US biopharma Syndax.

“Our goal with the Keytruda development program is to help improve long-term disease control and survival for people suffering from a wide range of cancers,” adds Perlmutter.

The FDA has 60 days from submission of the NSCLC sBLA to determine if it will be accepted for review.

George Underwood

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