Combination therapy for melanoma promising in early trial

Results of a phase 1b trial of nivolumab combined with ipilimumab demonstrated one- and two-year survival rates of 94 and 88 percent, respectively, in patients with advanced melanoma.

The multi-arm, dose-ranging trial examined the activity and safety of the investigational drug nivolumab (Bristol-Myers Squibb) combined with ipilimumab (Yervoy, Bristol-Myers Squibb) concurrently or sequentially in 127 patients with advanced melanoma, according to a news release.

The one-year survival rate was 94 percent in patients receiving the concurrent combination regimen of nivolumab 1 mg/kg plus ipilimumab 3 mg/kg (n=17), study investigators determined after an additional year of follow-up of the cohort. Two-year survival for that dosage was 88 percent. Those doses are also being used in ongoing phase 2 and 3 trials.

“While these are phase 1b data, the duration of response and one- and two-year survival rates observed with the combination regimen of nivolumab and Yervoy are very encouraging and support the rationale for the ongoing, late-stage trials of this combination regimen,” Mario Sznol, M.D., Yale University School of Medicine and Yale Cancer Center, said in a statement. He presented the findings recently at the 50^th Annual Meeting of the American Society of Clinical Oncology.

The Food and Drug Administration granted Fast Track designation to nivolumab recently for treatment of melanoma, renal cell carcinoma and non-small cell lung cancer.

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