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Menzies, Alexander M; Amaria, Rodabe N; Rozeman, Elisa A; Huang, Alexander C; Tetzlaff, Michael T; van de Wiel, Bart A; Lo, Serigne; Tarhini, Ahmad A; Burton, Elizabeth M; Pennington, Thomas E; Saw, Robyn P M; Xu, Xiaowei; Karakousis, Giorgos C; Ascierto, Paolo A; Spillane, Andrew J; van Akkooi, Alexander C J; Davies, Michael A; Mitchell, Tara C; Tawbi, Hussein A; Scolyer, Richard A; Wargo, Jennifer A; Blank, Christian U; Long, Georgina V
Nature medicine, 02/2021, Volume: 27, Issue: 2Journal Article
The association among pathological response, recurrence-free survival (RFS) and overall survival (OS) with neoadjuvant therapy in melanoma remains unclear. In this study, we pooled data from six clinical trials of anti-PD-1-based immunotherapy or BRAF/MEK targeted therapy. In total, 192 patients were included; 141 received immunotherapy (104, combination of ipilimumab and nivolumab; 37, anti-PD-1 monotherapy), and 51 received targeted therapy. A pathological complete response (pCR) occurred in 40% of patients: 47% with targeted therapy and 33% with immunotherapy (43% combination and 20% monotherapy). pCR correlated with improved RFS (pCR 2-year 89% versus no pCR 50%, P < 0.001) and OS (pCR 2-year OS 95% versus no pCR 83%, P = 0.027). In patients with pCR, near pCR or partial pathological response with immunotherapy, very few relapses were seen (2-year RFS 96%), and, at this writing, no patient has died from melanoma, whereas, even with pCR from targeted therapy, the 2-year RFS was only 79%, and OS was only 91%. Pathological response should be an early surrogate endpoint for clinical trials and a new benchmark for development and approval in melanoma.
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