Ahmad Tarhini, MD, PhD
Ahmad Tarhini, MD, PhD, Director of Cutaneous and Translational Research at Moffitt Cancer Center, Tampa, was optimistic about neoadjuvant use of nivolumab/ipilimumab and looks forward to further randomized studies.
“Taken together, the results of the OpACIN and OpACIN-neo trials support the value of neoadjuvant therapy with nivolumab and ipilimumab in the treatment of locally and regionally advanced operable melanoma. In the phase I OpACIN trial, grade 3 or 4 adverse events were observed in 90% of patients in each arm of the study, leading to the premature discontinuation of the planned doses in that study. In follow-up, the reduced-dose regimen of the combination, as evaluated in the OpACIN-neo trial, was clearly significantly less toxic while maintaining the pathologic response rate seen with the combination. These data clearly support more definitive investigation of neoadjuvant nivolu-mab/ipilimumab in a randomized phase III setting,” Dr. Tarhini wrote in an e-mail.
Words of Caution
“The combination of nivolumab/ipilimumab makes sense, and the study is exciting, in that it sends a clear signal of activity in the neoadjuvant setting. However, the study was underpowered to allow firm conclusions. The number of patients is small, and larger studies are needed to confirm these findings,” said Larisa J. Geskin, MD, Director of the Comprehensive Skin Cancer Center, Columbia University Medical Center, Herbert Irving Medical Center, New York.
Larisa J. Geskin, MD
“That said, the combination of nivolumab/ipilimumab is quite toxic,” she continued. “Although neoadjuvant use of this combination is interesting in this study, half of these patients will not relapse, and the side effects of the combination are severe. It would be interesting to see a study of neoadjuvant nivolumab/ipilimumab vs nivolumab alone.”
DISCLOSURE: Dr. Tarhini has received institutional research funding from Merck, OncoSec, Genentech-Roche, and Bristol-Myers Squibb and has served as a consultant or advisor to Merck, Bristol-Myers Squibb, Novartis, Genentech-Roche, Array Biopharma, Partner Therapeutics, Sanofi-Genzyme/Regeneron, Pfizer, EMD Serono, NewLink Genetics, BioNTech, and Immunocore. Dr. Geskin reported no conflicts of interest.
The neoadjuvant combination of nivolumab and ipilimumab yielded a continued benefit in relapse-free survival vs adjuvant use of the same combination therapy in 20 patients with stage III macroscopic melanoma. This finding is based on 3-year follow-up results of the phase Ib OpACIN trial, presented...