Combo therapy yields intriguing results in melanoma progression

The results of a new study on a combination of drugs to treat melanoma, presented at the American Society of Clinical Oncology meeting in Chicago, are “unprecedented”.

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Researchers from Memorial Sloan Kettering Cancer Center and several other healthcare organizations in the United States and other countries found that a combination of ipilimumab and nivolumab stopped melanoma from advancing for nearly a year in 58% of cases. In addition to presenting their findings at the ASCO meeting, the study was published in the May 21, 2015, issue of the New England Journal of Medicine.

“For years, the best melanoma treatment demonstrated a 15% response rate, [while] this combination of ipilimumab and nivolumab has a response rate of about 60% This is unprecedented and means that, for the first time, patients going into a treatment regimen can know that they have better than a 50% chance that the treatment will shrink their tumors,” Tim Turnham, executive director of the Melanoma Research Foundation, told FormularyWatch.

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Among patients with BRAF wild-type tumors, the rate of confirmed objective response was 61% (44 of 72 patients) in the group that received both ipilimumab and nivolumab versus 11% (4 of 37 patients) in the group that received ipilimumab and placebo, the researchers found.

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“The data has shown that the combination of these drugs results in the highest response rates we have seen so far in melanoma. We know that some people who have taken these drugs separately have been cancer free for a long time-over 10 years in the case of ipilimumab,” Turnham said. “This suggests that an even greater number of people will have long-term responses to the combination, but we won’t know for sure until the data are in.”

However, both the researchers and Turnham cautioned about the high rate of side effects with the combination of nivolumab and ipilimumab. In the study, 36% of the patients had to stop the therapy due to side effects. 

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“The side effects of this combination are much higher than we saw with either drug alone. For the most part, though, they were manageable through careful monitoring,” Turnham said. The side effects will mean that some patients should consider other treatments first, according to Turnham.

“However, we have seen in other new drugs that, over time, the treatment teams learn how to manage those side effects effectively. I don’t believe that more research is needed before patients are given access to this regimen, but am anxious to see the final data on overall survival.”

The study was funded by Bristol-Myers Squibb.