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Safety, activity, and pharmacokinetics of camrelizumab in advanced Asian melanoma patients: a phase I study
oleh: Li Zhou, Xiaowen Wu, Zhihong Chi, Lu Si, Xinan Sheng, Yan Kong, Lili Mao, Bin Lian, Bixia Tang, Xieqiao Yan, Xuan Wang, Xue Bai, Siming Li, Xiaoting Wei, Juan Li, Qing Yang, Jun Guo, Chuanliang Cui
| Format: | Article |
|---|---|
| Diterbitkan: | BMC 2022-05-01 |
Deskripsi
Abstract Background Anti-programmed cell death receptor-1 (PD-1) monotherapy is the standard treatment for metastatic melanoma in current. Camrelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody whose safety and efficacy have not been reported in advanced Asian melanoma patients. Methods This phase I study investigated the safety, activity, and pharmacokinetics of camrelizumab in Chinese patients with advanced melanoma. The study included two phases, the dose-escalation phase (“3 + 3” design at 60 mg, 200 mg, and 400 mg) and the dose-expansion phase. Results No dose-limiting toxicities were recorded over the dose-escalation phase, and the maximum tolerated dose was not reached. The most common treatment-related adverse events (TRAEs) in 36 patients were reactive cutaneous capillary endothelial proliferation, followed by rash, fever, hypothyroidism, hyperthyroidism, vitiligo, and fatigue. Five grade 3 or above TRAEs were reported (13.9%), including two cases of elevated γ-glutamyltransferase and blood triglycerides without clinical symptoms, and one liver injury recovered after symptomatic treatment. The confirmed overall response rate was 13.9% (95%CI: 4.7, 29.5%) and disease control rate was 38.9% (95%CI: 23.1, 56.5%). The median progression-free survival was 1.8 months (95%CI: 1.1, 2.4) and the median overall survival was 11.1 months (95%CI: 6.8, 15.4). Conclusions Camrelizumab had acceptable tolerability and similar anti-tumor activity compared with other anti-PD-1 antibodies in advanced Asian melanoma patients. Trial registration ClinicalTrials.gov identification: NCT02738489. Registered on 14/04/2016, prospectively registered.