Monday, June 3, 2013 (Last Updated: 06/04/2013)MONDAY, June 3 (HealthDay News) -- Lambrolizumab and concurrent nivolumab and ipilimumab are active in advanced melanoma, according to two studies published online June 2 in the New England Journal of Medicine to coincide with presentation at the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago.
Omid Hamid, M.D., from the Angeles Clinic and Research Institute in Los Angeles, and colleagues administered lambrolizumab intravenously every two or three weeks to 135 patients with advanced melanoma. The researchers found that common treatment-related adverse events included fatigue, rash, pruritus, and diarrhea, most of which were low grade. Across all dose cohorts, the confirmed response rate was 38 percent, with the highest confirmed response rate seen for patients who received 10 mg/kg every two weeks. The response rate was not affected by prior treatment with ipilimumab.
Jedd D. Wolchok, M.D., Ph.D., from the Memorial Sloan-Kettering Cancer Center in New York City, and colleagues conducted a phase 1 trial of nivolumab combined with ipilimumab every three weeks for four doses, followed by nivolumab alone every three weeks for four doses (concurrent regimen) for 53 patients with advanced melanoma. The researchers found that the objective-response rate was 40 percent and evidence of clinical activity was seen in 65 percent of patients. An objective response was observed in 53 percent of patients at the maximum doses associated with an acceptable level of adverse events.
"Concurrent therapy with nivolumab and ipilimumab had a manageable safety profile and provided clinical activity that appears to be distinct from that in published data on monotherapy, with rapid and deep tumor regression in a substantial proportion of patients," Wolchok and colleagues write.
Several authors from the Hamid study disclosed financial ties to pharmaceutical companies, including Merck Sharp and Dohme, which funded the study. Several authors from the Wolchok study disclosed financial ties to pharmaceutical companies, including Bristol-Myers Squibb and Ono Pharmaceutical, which funded the study.
Hematology & Oncology