Novel Immunotherapy Drug Pembrolizumab ‘Fast-Tracked’ for Advanced Melanoma

Novel Immunotherapy Drug Pembrolizumab ‘Fast-Tracked’ for Advanced Melanoma

shutterstock_169068299 (1)Under a new United Kingdom Government scheme, the novel immunotherapy drug Pembrolizumab has become the first treatment ‘fast-tracked’ for National Health Service (NHS) patients with advanced melanoma.

“It’s a step in the right direction in terms of patients getting access to new treatments faster,” said Emma Greenwood, Cancer Research UK head of policy, in a news release.

Every year in the UK approximately 13,300 individuals are diagnosed with melanoma, the 5th most frequent form of cancer in UK. In Great Britain the rates of skin cancer increased more than 5 times since mid 1970s. It is now the second most frequent cancer in individuals under 50 years of age, with the highest incidence in people over 85 years old.

Cancer has evolved to take advantage of multiple mechanisms in escape immune-cell recognition and anti tumor effector functions, reducing the clinical benefits of immunotherapy strategies. Pembrolizumab is an antibody that binds to a molecule on the surface of immune cells, called programmed cell death 1 (PD-1), to block the negative immune regulatory signaling of the PD-1 receptor expressed by T cells, enabling the tumor-specific T cells to perform their cytotoxic function against the tumor, i.e. kill the tumor. Most of the research on understanding the role of PD-1 in cancer was done in the US. However, an important step in the development, generating an antibody that would not be itself recognized by the immune system and destroyed, was discovered by UK scientists from the Medical Research Council (MRC).

The drugs used in immunotherapy have shown significant promising results in clinical trials with cancer patients. They function by blocking the mechanisms of immune evasion used by cancer cells to escape the immune system.

A drug called Keytruda was the first FDA-approved as an anti–PD-1 therapy and was first to be signed off through the Early Access to Medicines Scheme (EAMS), which quickly proves ground-breaking drugs to very sick patients.

Importantly, in the UK physicians can now apply to prescribe the drug before normal European licensing procedures are complete, a process that takes many years.

Since the approval in 2012 of Ipilimumab for melanoma, Pembrolizumab is now the second immunotherapy for cancer. Several studies have suggested that both drugs could be even more effective if used in combination and potentially together with radiotherapy.

Dr. Emma Greenwood said this announcement highlighted a major advance in the development of immune therapies for cancer.

“It’s encouraging to see it being made available to patients earlier. NICE and the Cancer Drugs Fund only look at licensed drugs, so it’s a step in the right direction in terms of patients getting access to new treatments faster,” said Dr. Greenwood.

“With this approach, relevant data will be collected and patients are closely monitored. We look forward to seeing whether it can be replicated with other promising drugs,” she concluded.

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