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Merck could win anti-PD1 therapy race in Europe

EMA accepts filing for promising pembrolizumab in melanoma
Merck and Co - US headquarters

The European Medicines Agency (EMA) has accepted Merck & Co's filing for its anti-PD1 antibody pembrolizumab for the treatment of advanced melanoma, putting it in contention to be the first drug in its class to reach the EU market.

Pembrolizumab (formerly lambrolizumab; MK-3475) is one of the highlights of Merck's R&D pipeline and is being evaluated across more than 30 types of cancer, with peak sales estimated to reach around $500m in melanoma alone.

Additional regulatory filings in other countries outside of Europe are planned by the end of 2014, the company said.

Roy Baynes, senior vice president of clinical development at Merck Research Laboratories, said there is a pressing need for new therapies given that "the five-year survival rate for patients with advanced melanoma [is] less than 20 per cent".

Pembrolizumab was filed for approval in the US in January and could be approved by the FDA as early as October is all proceeds as expected with the 'rolling' Biologics License Application (BLA), which involves the stepwise submission of data during the regulatory review process.

Merck is racing with Bristol-Myers Squibb (BMS) to bring an anti-PD1 therapy to market as a melanoma treatment, with the latter's nivolumab candidate submitted under a rolling BLA in the US in April. Other anti-PD1 or anti-PDL1 drugs coming through development include Roche's MPDL-3280A, while AstraZeneca and Novartis are also active in this area.

In February 2014, Merck formed collaborations with Pfizer, Amgen and Incyte to explore the use of pembrolizumab in combination with other drugs across a variety of tumour types, including melanoma, renal cell carcinoma, non-small cell lung cancer (NSCLC) and breast cancer.

Cancer immunotherapies such as the anti-PD-1/PD-L1 agents are predicted to be one of the key growth categories in the cancer immunotherapy market, which is predicted to grow from $1.1bn in 2012 to nearly $9bn in 2022 in the US, France, Germany, Italy, Spain, UK and Japan, according to just-published market research from Decision Resources.

"We anticipate that nivolumab will be the sales-leading agent among immunotherapies," said Decision Resources analyst Khurram Nawaz.

"However, it will face direct and intense competition from other anti-PD1/PDL1 agents - notably from pembrolizumab in malignant melanoma and NSCLC -and, to a lesser extent, from MPDL-3280A in NSCLC," he added.

Article by
Phil Taylor

1st July 2014

From: Research, Sales, Regulatory

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