Pembrolizumab in Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma: Final Analysis of KEYNOTE-170
Mené sur des patients atteints d'un lymphome médiastinal primitif à grandes cellules B récidivant ou réfractaire (durée médiane de suivi : 48,7 mois), cet essai évalue l'efficacité, du point de vue du taux de réponse objective, de la survie sans progression et de la durée de la réponse, et la toxicité du pembrolizumab
Previous analyses of the phase 2 KEYNOTE-170 (NCT02576990) study demonstrated effective antitumor activity and acceptable safety of pembrolizumab 200 mg given every 3 weeks for up to 35 cycles (~2 years) in patients with relapsed/refractory (R/R) primary mediastinal B-cell lymphoma (PMBCL) whose disease progressed after or who were ineligible for autologous stem cell transplantation. End points included objective response rate (ORR), progression-free survival (PFS), and duration of response (DOR) by investigator per 2007 Response Criteria; overall survival (OS); and safety. In this final analysis, median duration of follow-up was 48.7 months (range, 41.2-56.2). ORR was 41.5% (complete response, 20.8%; partial response, 20.8%). Median DOR was not reached; no patients who achieved complete response had progressed at the data cutoff. Median PFS was 4.3 months; 4-year PFS rate was 33.0%. Median OS was 22.3 months; 4-year OS rate was 45.3%. At the data cutoff, 30 patients (56.6%) had any-grade treatment-related adverse events (AEs); the most common were neutropenia, asthenia, and hypothyroidism. Grade 3 or 4 treatment-related AEs occurred in 22.6% of patients; no grade 5 AEs occurred. After 4 years of follow-up, pembrolizumab continued to provide durable responses, with promising trends for long-term survival and acceptable safety in R/R PMBCL.
Blood 2023