A single-arm, multicenter, phase 2 study of camrelizumab in relapsed or refractory classical Hodgkin lymphoma
Mené en Chine sur 75 patients atteints d'un lymphome hodgkinien classique réfractaire ou récidivant, cet essai de phase II évalue l'efficacité, du point de vue du taux de réponse objective, et la toxicité du camrélizumab, un anticorps ciblant PD-1 (durée médiane de suivi : 12,9 mois)
Purpose: For classical Hodgkin lymphoma (cHL), programmed death-l (PD-1) is a well-recognized attractive target. This multicenter, single-arm, phase 2 study evaluated the efficacy and safety of camrelizumab, a humanized high-affinity IgG4 monoclonal antibody against PD-1, in Chinese patients with relapsed or refractory cHL. Experimental Design: Patients who had failed to achieve a remission or experienced progression after autologous stem cell transplantation or had received at least 2 lines of systemic chemotherapies were given camrelizumab 200 mg every 2 weeks. The primary endpoint was objective response rate per independent review committee (IRC) assessment. This study is registered with ClinicalTrials.gov, number NCT03155425. Results: Between Jun 9, 2017 and Sep 18, 2017, 75 patients were enrolled and treated. At a median follow-up of 12.9 months, 57 of 75 (76.0%; 95% CI, 64.7-85.1) patients achieved an IRC-assessed objective response, including 21 (28.0%) and 36 (48.0%) patients who had complete and partial remission, respectively. Median duration of response was not reached (range, 0.0+-12.8+ months). Treatment-related adverse events (AEs) occurred in all patients. The most common ones included cutaneous reactive capillary endothelial proliferation (97.3%, 73/75) and pyrexia (42.7%, 32/75). Grade 3 or 4 treatment-related AEs occurred in 20 patients (26.7%), with the most common one being white blood cell decreased (4.0%, 3/75). There were no grade 5 treatment-related AEs. Conclusions: Camrelizumab demonstrated high response rate, durable response and controllable safety in Chinese patients with relapsed or refractory cHL, becoming a new safe and effective treatment option in this setting.