A pioneering new drug appears to have cured a British man with advanced skin cancer who had been given just months to live.

Doctors cannot be certain it was the treatment that led to the “miraculous” outcome for 64-year-old Warwick Steele, but know of no other explanation.

Results from an early-stage trial of the drug indicate that it may offer a potential “paradigm shift” in cancer therapy, according to Steele’s consultant.

The drug, pembrolizumab, is the latest in a new generation of treatments that prevent cancers shielding themselves from the immune system.

It was tested on melanoma – the most dangerous form of skin cancer – because the prospects for patients with advanced forms of this disease are so bleak.

Just under 70 per cent of the 411 patients taking part in the trial were still alive one year after starting on the treatment.

The result is considered remarkable because all had highly advanced melanoma and a very poor prognosis.

Currently one-year survival rates for untreated patients diagnosed with advanced stage four melanoma are just 10 per cent for men and 35 per cent for women.

Steele, a television engineer from Ruislip, west London, had undergone six months of treatment with pembrolizumab, which is injected into the bloodstream.

Doctors were astonished when after just three months his tumours had almost disappeared. Since then they have shown no sign of returning – and in fact have shrunk even further.

His consultant, David Chao, from the Royal Free Hampstead NHS Trust in London, said: “We cannot say for certain that he’s been cured, but he is doing very well. He was aware that without an effective treatment his survival prospects were not good – maybe months.

“Pembrolizumab looks like it has potential to be a paradigm shift for cancer therapy and is firmly helping to establish immunotherapy as one of the most exciting and promising treatment modalities in recent years.

“This is one of several new drugs of this type being produced. What these early trials are showing is that they are fulfilling their promise ridiculously fast.

“Some of these results are really astonishing; almost jaw-dropping. And these drugs may be applicable to many different cancer types, including ones that are hard to treat, such as lung cancer.

“Cancers adapt to treatments, and when they come back they are harder to treat. Can we dream about actually curing some of our patients with very advanced cancer? Once we get the immune system attacking the cancer, can it act independently to keep the cancer under control? We don’t have all the answers yet, but that’s what we’re looking at.”

Pembrolizumab is a synthetic antibody that blocks a biological pathway called programmed cell death 1 (PD-1) which cancers activate to suppress the immune system.

In healthy individuals, PD-1 is part of the process that applies a “brake” to the immune system and prevents it running out of control.

Without the brake, there is a risk of a harmful inflammatory reaction - a potential serious side-effect of the new drugs.

Pembrolizumab was generally “well tolerated” by the trial patients, according to Chao, but he said responses varied widely between individuals.

Results from the trial were presented at the annual meeting of the American Society of Clinical Oncology in Chicago.

Clinicians do not yet know the true extent of how pembrolizumab might affect survival. After 18 months, 62 per cent of patients were still alive and undergoing treatment.

In addition, around 80 per cent of patients responded to the drug – an unusually high proportion.

A total of 72 per cent experienced tumour shrinkage, including 39 per cent whose tumours were more than halved in size, according to one kind of assessment.

Additional data showed that the drug also reduced the size of advanced non-small cell lung cancers by up to 47 per cent.

Pembrolizumab’s manufacturer, the pharmaceutical company Merck Sharp & Dohme, is expected to apply for a European licence to market the drug within months.

Gillian Nuttall, founder of the charity Melanoma UK, said: “Advanced melanoma is a terrible disease with a poor prognosis. Pembrolizumab represents the latest advance in a whole raft of new treatments in advanced melanoma which have come through over the past few years.

“The pembrolizumab results are really exciting and could represent a turning point for patients affected by advanced melanoma, giving them a greater chance of survival.”

Chao told BBC Breakfast that it was “far too early” to say whether a patient had been cured.

“I think one of the difficulties will be managing the expectation both of patients but also of doctors as well. I think it is far too early to say that a patient has necessarily been cured by these treatments as yet. I think only time will tell, literally,” he said.

“The major problem with cancer. even with successful treatments in the past, is that the cancers have adapted to our treatments and they come back.

“I think one of the hopes of immunotherapy is that, by harnessing the power of the immune system, the immune system will adapt to the cancer and therefore will be able to keep it under control, possibly for a very long time, possibly leading to a cure but I think only time will tell.”