Camrelizumab Biosimilar, PD-1

Camrelizumab Biosimilar uses the same protein sequences as the therapeutic antibody camrelizumab. Camrelizumab is an IgG4κ humanized monoclonal antibody being investigated for hepatocellular carcinoma. It targets programmed cell death protein 1 (PD-1), a protein on the surface of cells, also known as CD279 (cluster of differentiation 279). Camrelizumab is being evaluated in the Phase 2/3 (NCT02989922) of patients with advanced hepatocellular carcinoma (HCC) in second-line after failure or intolerance to prior systemic treatment. The study has 2 arms in which patients will be intravenous administered 3 mg/kg SHR-1210 on day 1 every 2 weeks or every 3 weeks. The primary outcome measures are the overall response rate (ORR) and overall survival (OS) rates at 6 months with duration of response and OS at 2 years as secondary endpoints. The estimated enrollment is 220 patients, and the estimated primary completion date is December 2018. A randomized, open-label Phase 3 study (NCT03099382) is evaluating the efficacy of camrelizumab treatment compared to standard-of-care treatment (docetaxel or irinotecan) in patients with esophageal carcinoma. Patients are randomly assigned to receive either SHR-1210 (200 mg every 2 weeks) or the standard of care (docetaxel 75 mg/m2 on day 1 every 3 weeks or irinotecan 180 mg/m2 on day 1 every 2 weeks). This Phase 3 study has an estimated enrollment of 438 and an estimated primary completion date of June 2018.