Melanoma breakthrough for Merck
pharmafile | April 26, 2013 | News story | Research and Development, Sales and Marketing | FDA, Merck, lambrolizumab, melanoma
Merck’s pipeline has been given a boost by an FDA decision to designate early-stage investigational drug lambrolizumab as a breakthrough therapy to treat advanced melanoma.
The company is at pains to point out that simply being put in this bracket will not necessarily mean the drug is going to be successful but it could help to speed up considerably its passage through the regulatory maze.
Lambrolizumab targets programmed death receptor (PD-1) and is currently being evaluated for the treatment of patients with advanced melanoma and other tumour types, including non-small cell lung cancer.
Breakthrough designation is for drug candidates that might be used alone or in combination to treat a serious or life-threatening disease.
While advanced melanoma accounts for only around two per cent of all cancer deaths in the US, it still kills around 9,000 people and is behind more than four-fifths of skin cancer-related deaths.
Another key point about the designation is that it comes after preliminary clinical evidence indicates that a drug may demonstrate “substantial improvement over existing therapies on one or more clinically significant endpoints”.
What has got the FDA interested is that early interim results from a single-arm, open-label Phase Ib study of lambrolizumab presented last November, demonstrated that it showed promise against Bristol-Myers Squibb’s Yervoy (ipilimumab), the current standard of care for late-stage melanoma.
Of 85 patients with inoperable and metastatic melanoma, 43 showed an objective anti-tumour response on lambrolizumab, with eight of them showing a complete response at or after the 12-week assessment.
Merck drew attention to the fact that only 11 of the 27 patients who had previously been treated with Yervoy showed an objective anti-tumour response to lambrolizumab monotherapy, and none of those showed a complete response.
Although it is very early days, the US regulator’s recognition of lambrolizumab’s potential – it is designed to disrupt the action of the immune checkpoint protein PD-1 and stop some cancers ‘fooling’ the body’s immune system – could give it a leg-up.
“The FDA’s decision to place lambrolizumab in a category that may enable expedited development and review is an important milestone for Merck as we advance ongoing programs in multiple cancer indications,” said Gary Gilliland, senior vice president and oncology franchise head, Merck Research Laboratories.
Adam Hill
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