Nivolumab+AVD in Advanced-Stage Classic Hodgkin’s Lymphoma

作者：Alex F. Herrera, Michael LeBlanc, Sharon M. Castellino, Hongli Li, Sarah C. Rutherford, Andrew M. Evens, Kelly Davison, Angela Punnett, Susan K. Parsons, Sairah Ahmed, Carla Casulo, Nancy L. Bartlett, Joseph M. Tuscano, Matthew Mei, Brian Hess, Ryan Jacobs, Hayder Saeed, Pallawi Torka, Boyu Hu, Craig H. Moskowitz, Supreet Kaur, Gaurav Goyal, Christopher J. Forlenza, Andrew Doan, Adam J. Lamble, Pankaj Kumar, Saeeda Chowdhury, Brett T. Brinker, Namita Sharma, Avina K. Singh, Kristie A. Blum, Anamarija M. Perry, Alexandra E. Kovach, David Hodgson, Louis S. Constine, Lale Kostakoglu Shields, Anca Prica, Hildy Dillon, Richard F. Little, Margaret A. Shipp, Michael Crump, Brad S. Kahl, John P. Leonard, Sonali M. Smith, Joo Y. Song, Kara M. Kelly, Jonathan W. Friedberg · 发表于：New England Journal of Medicine · 年份：2024 · DOI：10.1056/nejmoa2405888 · 被引用次数：223 · 研究领域：Lymphoma Diagnosis and Treatment、Radiopharmaceutical Chemistry and Applications、CNS Lymphoma Diagnosis and Treatment

BACKGROUND: Incorporating brentuximab vedotin into the treatment of advanced-stage classic Hodgkin's lymphoma improves outcomes in adult and pediatric patients. However, brentuximab vedotin increases the toxic effects of treatment in adults, more than half of pediatric patients who receive the drug undergo consolidative radiation, and relapse remains a challenge. Programmed death 1 blockade is effective in Hodgkin's lymphoma, including in preliminary studies involving previously untreated patients. METHODS: We conducted a phase 3, multicenter, open-label, randomized trial involving patients at least 12 years of age with stage III or IV newly diagnosed Hodgkin's lymphoma. Patients were randomly assigned to receive brentuximab vedotin with doxorubicin, vinblastine, and dacarbazine (BV+AVD) or nivolumab with doxorubicin, vinblastine, and dacarbazine (N+AVD). Prespecified patients could receive radiation therapy directed to residual metabolically active lesions. The primary end point was progression-free survival, defined as the time from randomization to the first observation of progressive disease or death from any cause. RESULTS: Of 994 patients who underwent randomization, 970 were included in the intention-to-treat population for efficacy analyses. At the second planned interim analysis, with a median follow-up of 12.1 months, the threshold for efficacy was crossed, indicating that N+AVD significantly improved progression-free survival as compared with BV+AVD (hazard ratio f...