As discussant of the nivolumab paper presented by Weber et al at the ESMO Presidential Symposium, Ignacio Melero, MD, PhD, of the Universidad de Navarra in Spain, said “We are presented today with very exciting clinical data. The only disappointment is that the survival data are not mature.”
Dr. Weber reported “a very impressive objective response rate of 32%, not including cases that look to me like pseudoprogression,” he said. The adverse event profile of the drug “looks favorable,” he added, and he was particularly encouraged by the lack of pneumonitis.
The study population, the response rate and the safety profile are similar to that recently described for the anti–PD-1 agent pembrolizumab (Keytruda) in ipilimumab (Yervoy)-refractory patients,1 he noted. In that phase I study, the response rate was 26% and the overall survival was “impressive,” he said, “not reaching the median overall survival at 14 months.”
Tip of the Iceberg
Showing a Kaplan-Meier curve of progression-free survival, he commented, “We have now to focus on the area over the curve, because it is made of death, pain, and suffering. It is likely that at least part of that area will be addressable by immunotherapy…. I believe that melanoma treatment with anti–PD-1 is only the tip of the iceberg…. The trend one can foresee is that we will be moving PD-1 blockade up front in treatment…. The best is yet to come, particularly with combinations in immunotherapy.”
Dr. Melero remarked in closing, “From this exciting ESMO Congress, it is clear that the main conclusion is this: immunotherapy of cancer is no longer a quixotic task.” ■
Disclosure: Dr. Melero has served as an advisor to Bristol-Myers Squibb, Roche/Genentech, and AstraZeneca.
Reference
1. Robert C, Ribas A, Wolchok JD, et al: Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: A randomized dose-comparison cohort of a phase 1 trial. Lancet 384:1109-1117, 2014.
