PD-1 cancer race heats up as Merck takes lead
Merck’s oncology drug pembrolizumab has taken a big step towards becoming Europe’s first PD-1 cancer treatment as the EMA accepts the medicine for review.
Specifically, the EMA will now look at pembrolizumab (MK-3475) for the treatment of advanced melanoma, the deadliest form of skin cancer.
Merck adds that additional regulatory filings in other countries outside of Europe are planned ‘by the end of 2014’ and analysts are expecting peak sales of around $500 million for a licence in melanoma.
The drug was filed for approval in the US in January and could be approved by the FDA by October.
“With the five-year survival rate for patients with advanced melanoma at less than 20%, there remains a need to offer patients additional options,” says Roy Baynes, senior VP of clinical development at Merck Research Laboratories.
“We are pleased to have regulatory applications under review in the US and Europe as we work toward bringing pembrolizumab to patients around the world.”
If approved by the European Commission, pembrolizumab has the potential to be the first licensed anti-PD-1 therapy in Europe, putting Merck ahead of its rivals in this lucrative market.
The therapy, known as programmed cell death 1 (PD-1) protein and its PD-L1 ligand, is a form of immunotherapy that helps the body recognise and destroy cancer cells, and was the hottest topic of research at June’s ASCO cancer conference in Chicago.
Major players such as Roche, AstraZeneca and Bristol-Myers Squibb also have candidates in development, with all vying for pole position in the race to a market potentially worth up to $25-35 billion per year.
But of all these medicines, Merck’s pembrolizumab won particular plaudits from the ASCO board, both for its efficacy and side effects profile.
Describing a study of the drug’s impact on patients with advanced melanoma, Steven O’Day of the organisation’s Cancer Communications Committee said that the low incidence of serious toxicity is ‘unheard of in this setting’.
According to lead researcher Antoni Ribas, O’Day is not overstating pembrolizumab’s relatively mild side effects: “This is one of the most benign therapies I’ve ever used in my clinic,” he says of the new treatment, which was found to have a one-year overall survival rate of 69 per cent.
Merck is also investigating pembrolizumab in lung, as well as head and neck cancer, with a Phase III trial in the former setting expected to start later this year.
O’Day points out that one of the most promising trends in immunotherapy is that research is moving beyond its initial focus of skin cancer to other forms of the disease. “The revolution is here,” he declares, “and it’s bursting out of melanoma into solid tumours”.
BMS is also expected to target lung cancer with a combination of two immuno-oncology drugs: the experimental nivolumab and the already-approved ipilimumab (Yervoy) for melanoma.