He cautioned, however, that the toxicities with the combined drugs, primarily driven by ipilimumab, "are not inconsequential."
"We heard today that a phase III trial has been initiated, presumably with a lower-dose ipi[limumab] arm, but I think that’s really a gutsy move, considering that there were only 21 patients in that subset of patients that led to this phase III decision. Just a fair warning to everyone that toxicities observed in a phase I trial tend to magnify in a larger phase III when you have more centers, different eligibility criteria, and less experienced folks administering a pretty toxic combination," he said.
The study was funded by Bristol-Myers Squibb and Ono Pharmaceutical. Dr. Hammers has received research funding from BMS. Dr. Lara disclosed serving as a consultant/advisor, and receiving honoraria and research funding from many companies, but not BMS.