AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma

• Published in: Journal of clinical oncology Vol. 37; no. 14; pp. 1188 - 1199
• Main Authors: Leonard, John P., Trneny, Marek, Izutsu, Koji, Fowler, Nathan H., Hong, Xiaonan, Zhu, Jun, Zhang, Huilai, Offner, Fritz, Scheliga, Adriana, Nowakowski, Grzegorz S., Pinto, Antonio, Re, Francesca, Fogliatto, Laura Maria, Scheinberg, Phillip, Flinn, Ian W., Moreira, Claudia, Cabeçadas, José, Liu, David, Kalambakas, Stacey, Fustier, Pierre, Wu, Chengqing, Gribben, John G.
• Format: Journal Article
• Language: English
• Published: United States American Society of Clinical Oncology 10.05.2019
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Female; Humans; Lenalidomide - administration & dosage; Lenalidomide - adverse effects; Lymphoma, B-Cell, Marginal Zone - drug therapy; Lymphoma, Follicular - drug therapy; Male; Middle Aged; Neoplasm Recurrence, Local - drug therapy; ORIGINAL REPORTS; Placebos; Rituximab - adverse effects; Rituximab - therapeutic use
• ISSN: 0732-183X; 1527-7755; 1527-7755
• DOI: 10.1200/JCO.19.00010

Patients with indolent non-Hodgkin lymphoma typically respond well to first-line immunochemotherapy. At relapse, single-agent rituximab is commonly administered. Data suggest the immunomodulatory agent lenalidomide could increase the activity of rituximab. A phase III, multicenter, randomized trial of lenalidomide plus rituximab versus placebo plus rituximab was conducted in patients with relapsed and/or refractory follicular or marginal zone lymphoma. Patients received lenalidomide or placebo for 12 cycles plus rituximab once per week for 4 weeks in cycle 1 and day 1 of cycles 2 through 5. The primary end point was progression-free survival per independent radiology review. A total of 358 patients were randomly assigned to lenalidomide plus rituximab (n = 178) or placebo plus rituximab (n = 180). Infections (63% 49%), neutropenia (58% 23%), and cutaneous reactions (32% 12%) were more common with lenalidomide plus rituximab. Grade 3 or 4 neutropenia (50% 13%) and leukopenia (7% 2%) were higher with lenalidomide plus rituximab; no other grade 3 or 4 adverse event differed by 5% or more between groups. Progression-free survival was significantly improved for lenalidomide plus rituximab versus placebo plus rituximab, with a hazard ratio of 0.46 (95% CI, 0.34 to 0.62; < .001) and median duration of 39.4 months (95% CI, 22.9 months to not reached) versus 14.1 months (95% CI, 11.4 to 16.7 months), respectively. Lenalidomide improved efficacy of rituximab in patients with recurrent indolent lymphoma, with an acceptable safety profile.