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Lambrolizumab shows promise in melanoma
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The novel anti–PD-1 antibody lambrolizumab was associated with response rates of more than 35% in a cohort of patients with advanced melanoma, according to study results.
The analysis included 135 patients. Researchers assigned patients to lambrolizumab (Merck) — previously known as MK-3475 — in one of three doses: 10 mg/kg IV every 2 weeks, 10 mg/kg every 3 weeks, or 2 mg/kg every 3 weeks.
Patients who had received ipilimumab (Yervoy, Bristol-Myers Squibb) were eligible for the trial.
The researchers evaluated tumor response every 12 weeks.
Low-grade fatigue, rash, pruritus and diarrhea were the most commonly reported adverse events.
The overall response rate, according to RECIST criteria, was 38% (95% CI, 25-44).
Patients in the 10 mg/kg every 2 weeks cohort demonstrated a 52% confirmed response rate, the highest of any dosing regimen (95% CI, 38-66).
Prior ipilimumab therapy did not affect response. The response rate among those previously treated with ipilimumab was 38% (95% CI, 23-55) vs. 37% (95% CI, 26-49) in the ipilimumab-naive cohort.
At 11 months of median follow-up, 81% of responders were still receiving treatment. Median PFS among all 135 patients was longer than 7 months.
“In patients with advanced melanoma, including those who had had disease progression while they had been receiving ipilimumab, treatment with lambrolizumab resulted in a high rate of sustained tumor regression, with mainly grade 1 or 2 toxic effects,” the researchers concluded. “The striking anticancer activity observed with lambrolizumab requires confirmation in larger studies.”
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