Camrelizumab for relapsed or refractory classical Hodgkin lymphoma: extended follow-up of the multicenter, single-arm, phase 2 study
Mené 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, après l'échec d'une greffe autologue de cellules souches ou de deux lignes ou plus de chimiothérapies (durée médiane : 36,2 mois)
Résumé en anglais
Camrelizumab (a humanized high-affinity IgG4 mAb against PD-1) showed potent antitumor activity, well tolerance, and controllable safety in patients with relapsed or refractory classical Hodgkin lymphoma (r/r cHL), based on the primary analysis of a phase 2 study. Here, we present the extended follow-up outcomes. Seventy-five patients who had failed to achieve a remission or experienced progression after autologous stem cell transplantation or had received at least two lines of systemic chemotherapies were enrolled to receive camrelizumab 200 mg every 2 weeks. With a median follow-up of 36.2 months (range, 7.2-38.1), objective response rate per independent central review was 76.0% (95% CI, 64.7-85.1). Among the 57 responders, 31 (54.4%) had ongoing responses. Median duration of response was 31.7 months (95% CI, 16.7-not reached). Median progression-free survival was 22.5 months (95% CI, 14.7-not reached). 36-month overall survival rate was 82.7% (95% CI, 72.0-89.5). Reactive capillary endothelial proliferation (RCEP) occurred in 97.3% of patients (73/75), but all RCEP were grade 1 or 2 in severity and 67.1% of these patients (49/73) achieved complete resolution. Occurrence of new RCEP lesions was rare (8/42 [19.0%] at 12 months; 2/32 [6.3%] at 24 months). No treatment-related deaths occurred, and no new toxicities were reported. With extended follow-up, camrelizumab monotherapy continues to provide a robust and durable response, long survival, and manageable safety in r/r cHL patients. This article is protected by copyright. All rights reserved.
