Kuruvilla John, Modi Dipenkumar, Santoro Armando, Paszkiewicz-Kozik Ewa, Gasiorowski Robin, Johnson Nathalie A, Fogliatto Laura Maria, Gonçalves Iara, de Oliveira Jose, Buccheri Valeria, Perini Guilherme Fleury, Goldschmidt Neta, Kriachok Iryna, Sekiguchi Naohiro, Lin Jianxin, Yusuf Rushdia, Marinello Patricia, Zinzani Pier Luigi
Princess Margaret Cancer Centre, Toronto, ON, Canada.
Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA.
Leuk Lymphoma. 2025 Sep;66(9):1710-1719. doi: 10.1080/10428194.2025.2502805. Epub 2025 Jun 23.
THIS REPORT FOCUSES ON A POST HOC EXPLORATORY ANALYSIS OF THE PHASE 3 KEYNOTE-204 STUDY COMPARING PEMBROLIZUMAB AND BRENTUXIMAB VEDOTIN BY NUMBER OF PRIOR LINES OF THERAPY IN PARTICIPANTS WITH RELAPSED/REFRACTORY (R/R) CLASSICAL HODGKIN LYMPHOMA (CHL). OF 304 PARTICIPANTS RANDOMLY ASSIGNED (1: 1) to pembrolizumab or brentuximab vedotin, 55 received 1 prior therapy and 249 received ≥2. For 1 prior therapy, median progression-free survival (PFS) at primary analysis (including clinical imaging data after autologous stem cell transplant [auto-SCT]) was 16.4 months with pembrolizumab and 8.4 months with brentuximab vedotin; objective response rate (ORR) was 66.7% and 53.6%. For ≥2 prior therapies, median PFS at primary analysis was 12.6 months with pembrolizumab and 8.2 months with brentuximab vedotin; ORR was 65.3% and 54.4%. Pembrolizumab improved PFS and ORR versus brentuximab vedotin regardless of prior therapies. Data suggest pembrolizumab may be a promising second-line therapy for participants with R/R cHL ineligible for auto-SCT.
ClinicalTrials.gov, NCT02684292.
本报告重点关注3期KEYNOTE-204研究的一项事后探索性分析，该研究比较了帕博利珠单抗和维布妥昔单抗在复发/难治性（R/R）经典型霍奇金淋巴瘤（CHL）患者中根据既往治疗线数的疗效。在304例随机分配（1:1）接受帕博利珠单抗或维布妥昔单抗治疗的患者中，55例接受过1线既往治疗，249例接受过≥2线既往治疗。对于接受过1线既往治疗的患者，初次分析时（包括自体干细胞移植[auto-SCT]后的临床影像数据）的中位无进展生存期（PFS），帕博利珠单抗组为16.4个月，维布妥昔单抗组为8.4个月；客观缓解率（ORR）分别为66.7%和53.6%。对于接受过≥2线既往治疗的患者，初次分析时的中位PFS，帕博利珠单抗组为12.6个月，维布妥昔单抗组为8.2个月；ORR分别为65.3%和54.4%。无论既往治疗情况如何，帕博利珠单抗与维布妥昔单抗相比均改善了PFS和ORR。数据表明，帕博利珠单抗可能是不适用于auto-SCT的R/R cHL患者有前景的二线治疗方案。
ClinicalTrials.gov，NCT02684292。
