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Camrelizumab anti-PD-1 with or without chemotherapy for NPC
By: News Feed | Last updated: 18th September 2018 | In: Chemotherapy, China, Head and Neck Cancer, ImmunoOncology, Immunotherapy, Oncology
camrelizumab, cisplatin, gemcitabine, Hengrui Medicine, Nasopharyngeal Carcinoma, nasopharynx, NPC, PD-1, SHR-1210
Camrelizumab (SHR-1210, Hengrui Medicine), a novel programmed death 1 (PD-1) inhibitor, plus gemcitabine and cisplatin showed a manageable toxicity profile with promising, preliminary anti-tumour activity in treatment-naïve Chinese nasopharyngeal carcinoma (NPC) patients. Larger, randomised controlled trials may provide further insight into the role of anti-PD1 for NPC, wrote the authors in the Lancet Oncology.
Two single-arm Phase I studies investigated anti-PD1 with camrelizumab in patients between 18-70 years-old with good performance status (ECOG 0-1) and histologically or cytologically confirmed recurrent or metastatic NPC. Patients (N=93) who received ≥1 line of prior therapy were treated in a Phase I dose-escalation and expansion study (NCT02721589) at five academic centres in China to receive camrelizumab monotherapy. Patients who were treatment-naïve patients enrolled into a separate Phase I study (NCT03121716) at a single site in China and treated with up to 6 cycles of camrelizumab plus gemcitabine and cisplatin, followed by maintenance camrelizumab. Both Phase I studies had the primary objective of safety and tolerability.
In the camrelizumab monotherapy study, 15 (16%) of 93 patients experienced Grade 3 or 4 treatment-related adverse events (TRAEs). The most common were elevated conjugated bilirubin concentration (3/93 patients; 3%), stomatitis (2/93 patients; 2%), anaemia (2/93 patients; 2%), and increased aspartate aminotransferase (AST, [2/93 patients; 2%]), alanine aminotransferase (ALT, [2/93 patients; 2%]), and total bilirubin (2/93 patients; 2%). Serious TRAEs occurred in 8 (9%) of 93 patients. The authors did not report dose-limiting toxicities during the dose-escalation phase. The efficacy was assessed in 91 patients at a median follow-up of 9·9 months, and 31 (34%; 95% CI, 24-44) had a response.
Twenty-three patients enrolled in the camrelizumab plus gemcitabine and cisplatin trial. Twenty (87%) of 23 patients experienced Grade 3 or 4 TRAEs: neutropenia (13/23 patients, 57%), anaemia (11/23 patients, 48%), leukopenia (11/23 patients, 48%), thrombocytopenia (7/23 patients, 30%), oedema (2/23 patients, 9%), hyponatraemia (2/23 patients, 9%), hypochloremia (1/23 patients, 4%), and rash (1/23 patients, 4%). Serious TRAEs occurred in 2 (9%) of patients. No treatment-related deaths were reported. At a median follow-up time of 10·2 months, overall responses were observed in 20 (91%) of 22 evaluable patients (95% CI, 72-97).
Fang W, et al. Lancet Oncol. 2018;doi: 10.1016/S1470-2045(18)30495-9.
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This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).