Bristol-Myers combination melanoma treatment shows promise

Skin cancer patients taking two Bristol-Myers Squibb drugs that help their immune systems fight melanoma saw their tumours shrink more dramatically than those on a single medication, according to a clinical study. The results from the mid-stage trial give credence to the theory that a combination of "immunotherapy" drugs will lead to a breakthrough in treating one of the world's deadliest diseases.

However, there are fears that healthcare systems will struggle to meet the cost of the expensive treatments, and that the approach could prove too dangerous for some patients.

Researchers said the combination of Opdivo and Yervoy, both made by Bristol-Myers, led to tumour shrinkage in 59 per cent of participants enrolled in the 142-patient phase-two trial, compared to 11 per cent for those taking Yervoy alone.

Over a fifth of patients (22 per cent) on both treatments had a complete response, meaning there was no sign of a tumour. There were no complete responses for patients on the single drug regimen.

Melanoma is the most serious form of skin cancer and strikes adults of all ages: it represents less than 5 per cent of skin cancer cases but still results in the most deaths.

The study was one of the first to test the combination of two immunotherapy drugs, which tackle cancer by removing so-called "brakes" in the immune system that stop the body from attacking tumour cells. Scientists hope cancer patients will respond more effectively if they are given two drugs, such as Opdivo and Yervoy, that target separate brakes.

However, there were signs that the administration of two drugs could be too toxic for some sufferers. There were three drug-related deaths associated with the Opdivo and Yervoy combination, while 54 per cent of patients on both treatments experienced serious side effects, such as colitis, an inflammation of the colon, and diarrhoea. Just a quarter of patients on Yervoy alone experienced serious side effects.

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Shares in Bristol-Myers rose 2 per cent on Friday amid hopes that Monday's presentation would confirm early-stage data showing the combination therapy was more effective than single treatments. The company also said a phase-three trial of Opdivo for a type of lung cancer was stopped early after interim analysis showed it improved survival rates.

Mark Schoenebaum, an analyst at Evercore ISI, said: "Today's data . . . essentially confirm that the combination of Opdivo and Yervoy in melanoma provides meaningfully greater efficacy than for the [single drugs] alone, albeit at a higher risk of toxicity." If phase three data confirm the findings, then Bristol-Myers' combination would probably become the most common treatment for those melanoma patients able to tolerate the side effects, he added.

Bristol-Myers said it expected to present phase three data on May 31 at the American Society of Clinical Oncology meeting, which will also show whether the drug increases overall survival rates. The timing of the presentation is well ahead of what most analysts were expecting, and would put the company on track to seek near-term regulatory approval to use the combination therapy for melanoma.

Some doctors fear that healthcare systems will struggle to pay for two immunotherapy drugs per patient: a year-long course of Opdivo costs about $150,000 while four rounds of Yervoy costs $120,000.

However, researchers found that the drug continued to benefit patients that had to stop treatment, and some doctors believe that fewer doses could still have a big effect. "It is noteworthy that of the patients who discontinued combination treatment owing to toxic effects, 68 per cent had [tumour shrinkage]," the researchers said.

"[The] results reinforce our belief that the future lies in the combination of immuno oncology agents . . . that can leverage the immune system in order to offer cancer patients options with greater efficacy beyond current treatment approaches," said Michael Giordano, head of oncology development at Bristol-Myers.

The findings come as Bristol-Myers and Merck contend for dominance in the immunotherapy market, which some analysts predict could generate annual peak sales of up to $30bn in the next decade. A study published on Sunday showed that Merck's competing treatment, Keytruda, gave patients a better chance of surviving melanoma than Yervoy.

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