Axitinib in combination with toripalimab, a humanized immunoglobulin G4 monoclonal antibody against programmed cell death-1, in patients with metastatic mucosal melanoma: An open-label phase IB trial
Journal of Clinical Oncology Aug 16, 2019
Sheng X, Yan X, Chi Z, et al. - Among 33 patients with advanced melanoma, including those with chemotherapy-naïve mucosal melanomas (88%), researchers tested toripalimab in combination with axitinib, focusing on the safety and preliminary effectiveness of this treatment option, in this single-center, phase IB trial. In this dose-escalation and cohort-expansion study, the patients were administered toripalimab at 1 or 3 mg/kg via intravenous infusion every 2 weeks, in combination with axitinib 5 mg orally twice a day. In Asian patients with treatment-naïve metastatic mucosal melanoma, tolerability and promising antitumor activity of the combination of toripalimab plus axitinib were evident in this study. To be used as a standard of care, validation of this combination therapy in a randomized phase 3 trial involving a non-Asian population is necessary. Diarrhea, proteinuria, hand and foot syndrome, fatigue, AST or ALT elevation, hypertension, hypo- or hyperthyroidism, and rash were the most common treatment-related adverse events and most were mild (grade 1 or 2).
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