Neoadjuvant PD-1 blockade in surgically resectable desmoplastic melanoma: cohort A of the phase 2 SWOG S1512 trial.
СтатьяКлиническое исследование II фазыНазвание и аннотация: Перевод пока не подготовлен
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Kendra Kari L, Bellasea Shay L, Eroglu Zeynep, Hu-Lieskovan Siwen, Campbell Katie M, Carson William E, Wada David A, Plaza Jose A, In Gino K, Ikeguchi Alexandra, Hyngstrom John, Brohl Andrew S, Chmielowski Bartosz, Khushalani Nikhil I, Markowitz Joseph, Monroe Marcus, Contreras Carlo M, Bowles Tawnya, Norman Kurt, Medina Egmidio, Gonzalez Cynthia R, Baselga-Carretero Ignacio, Garcilazo Ivan Perez, Vega-Crespo Agustin, Chen Jia Ming, Deen Nataly Naser Al, Patel Sapna P, Grossmann Kenneth F, Sondak Vernon K, Sharon Elad, Moon James, Wu Michael C, Ribas Antoni
Аннотация
The phase 2 SWOG S1512 trial ( NCT02775851 ) was designed to evaluate the response to pembrolizumab (anti-PD-1) in individuals with desmoplastic melanoma. Here we report the results of cohort A of the trial, evaluating the pathological complete response (pCR) rate of neoadjuvant PD-1 blockade in surgically resectable desmoplastic melanoma. Secondary endpoints included clinical response rate, overall survival and toxicities. Twenty-eight eligible individuals with resectable desmoplastic melanoma received intravenous pembrolizumab (200 mg) every 3 weeks three times, followed by excision. Tissue samples before treatment, at 3-5 weeks after treatment initiation and at the time of surgery were reviewed. The primary endpoint of pCR rate by local pathological review was 71% (95% confidence interval, 51-87%; P < 0.001), which met the prespecified endpoint. There were two (7%) grade 3 treatment-related adverse events. At three years of follow-up, four participants have died, none known to be from melanoma or adverse events. In conclusion, neoadjuvant pembrolizumab in individuals with resectable desmoplastic melanoma results in a high pCR rate with acceptable safety profile. Clinicaltrials.gov: NCT02775851 .