KEYNOTE-204: K药胜BV
KEYNOTE-024、KEYNOTE-042、KEYNOTE-204、KEYNOTE-224、KEYNOTE-240,已经分不清了
Merck’s KEYTRUDA® (pembrolizumab) Significantly Improved Progression-Free Survival Compared with Brentuximab Vedotin in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)
Data from Pivotal Phase 3 KEYNOTE-204 Study to be Presented at an Upcoming Medical Meeting and Submitted to Regulatory Authorities
KEYNOTE-204的内部分析中Pembro相比BV显著提升R/R cHL的PFS,达到其中1个主要终点,但未评估本研究的另一个主要终点OS。2017年FDA基于KEYNOTE-087临床2期的单臂结果加速批准了Pembro用于治疗难治性或≥3L治疗后仍复发的cHL,KEYNOTE-204是对应的上市后的证实性3期临床,评估Pembro对比BV。
回顾下KEYNOTE-087
2年随访结果
https://ashpublications.org/blood/article/134/14/1144/374896/Pembrolizumab-in-relapsed-or-refractory-Hodgkin
3年随访结果
https://ashpublications.org/blood/article/134/Supplement_1/240/426193/Three-Year-Follow-up-of-Keynote-087-Pembrolizumab
世道有轮回,苍天饶过谁。8年前的3月2日:
The ORR was 75% with complete remission (CR) in 34% of patients. The median progression-free survival time for all patients was 5.6 months, and the median duration of response for those in CR was 20.5 months. After a median observation time of more than 1.5 years, 31 patients were alive and free of documented progressive disease. The most common treatment-related adverse events were peripheral sensory neuropathy, nausea, fatigue, neutropenia, and diarrhea.
详细
https://clinicaltrials.gov/ct2/show/NCT02684292