Jeffrey S. Weber, MD, PhD, Director of the Donald A. Adam Comprehensive Melanoma Research Center at the Moffitt Cancer Center and Research Institute, Tampa, Florida, was very impressed by the response rate and survival outcomes.

“Responses were outstanding. Eight of nine patients in cohort 2 remain in response, as do 16 of 17 in the most recent cohort,” he noted. “And for the original 53 patients, 2-year survival is 79%. In metastatic melanoma, it doesn’t get any better than that.”

He continued, “This is not an atypical group of patients. I know from seeing them myself, that many have a sizable disease burden. Looking at these data, I cannot help but be impressed.”

Regarding the toxicities, Dr. Weber suggested that grade 3 elevations in lipase and amylase are not particularly worrisome, if patients are otherwise feeling well. “If these go to grade 4, we let the levels come down and keep treating,” he said. “Much of the toxicity occurs early, and generally we can safely continue to treat patients with nivolumab alone.”

Question to be answered pertain to the duration of treatment, need for maintenance, superiority of concurrent vs sequential treatment, and safety of continuing anti–PD-1 antibodies in the setting of grade 3/4 immune-related adverse events. Many of these questions will be answered in the current studies, he said.

Enrollment has been completed for a phase III trial comparing nivolumab plus ipilimumab vs nivolumab or ipilimumab alone and a phase II trial comparing nivolumab plus ipilimumab to ipilimumab alone.  ■

Disclosure: Dr. Weber reported no potential conflicts of interest.