ASCO: Ipilimumab improves recurrence-free survival in melanoma

Ipilimumab (Yervoy, Bristol-Myers Squibb) significantly improved recurrence-free survival in patients with stage 3 melanoma in the adjuvant setting, compared to placebo, according to data presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago.

The patients in this trial had already undergone surgical resection and were at a high risk for recurrence. But among those who received ipilimumab, there was a 25% reduction in the risk of recurrence or death (HR=0.75; 95% CI, 0.64–0.90; P=.0013). At 3 years, about 46.5% of patients treated with Yervoy were also free of disease recurrence, versus an estimated 34.8% of patients on placebo.

The median recurrence free survival was 26.1 months for ipilimumab versus 17.1 months for placebo, after a median follow-up of 2.7 years.

“Despite the strong likelihood of disease recurrence among stage 3 melanoma patients, there are very limited treatment options available to help reduce the risk of metastatic disease after surgery," commented lead author Alexander Eggermont, director general, Gustave Roussy Cancer Campus Grand Paris, Villejuif, France, in a release. "There is only one class of therapies available to patients and this standard of care has remained largely unchanged over the last 20 years."

He added that these findings are significant because "not only because ipilimumab is the first immune-checkpoint inhibitor to demonstrate an improvement in recurrence-free survival in this earlier treatment setting, but also because this benefit was observed across all patient sub-groups, including those who were at highest risk of recurrence."

Ipilimumab is currently approved at 3 mg/kg for metastatic melanoma, and in this phase 3 randomized, double blind study, it was given at 10 mg/kg (n=475). Additional studies are currently under way, including another phase 3 trial investigating the drug at doses of both 3 mg/kg and 10 mg/kg, or high-dose interferon alfa-2b in patients with high-risk stage 3 and resectable stage 4 melanoma.