Multicenter phase 1 study of neoadjuvant mogamulizumab plus nivolumab for solid tumors

Effector regulatory T cells expressing C-C chemokine receptor 4 (CCR4) suppress antitumor immune responses. A multicenter phase 1 trial in Japan evaluated the neoadjuvant combination of the anti-CCR4 antibody mogamulizumab and the anti-PD1 antibody nivolumab among 16 patients with solid tumors (renal, lung, esophageal and oral cancers). Grade 3 or 4 treatment-related adverse events were seen in 6 patients, with lymphopenia (25%) and maculopapular rash (13%) being the most frequent. Among patients with clinical responses there were three partial responses (one lung and two esophageal cancers) and among patients with pathological responses there was one complete response (lung cancer) and nine partial responses (five renal, two lung, and two esophageal cancers). The authors conclude that the neoadjuvant combination of mogamulizumab and nivolumab was tolerated and had antitumor effects among patients with soldi tumors.