Combination therapy for melanoma promising in early trial

June 3, 2014

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.

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 50th 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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