Publication date: May 20, 2022
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. 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. 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). Camrelizumab had acceptable tolerability and similar anti-tumor activity compared with other anti-PD-1 antibodies in advanced Asian melanoma patients. ClinicalTrials. gov identification: NCT02738489. Registered on 14/04/2016, prospectively registered.
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| 400mg | |
| Chinese | |
| Free | |
| Pharmacokinetics | |
| Tumor |