IBCL-081 MAGNIFY Phase 3b Study of Lenalidomide + Rituximab (R2) Followed by Maintenance in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma: Complete Induction Phase Analysis

Frederick Lansigan, David Jacob Andorsky, Morton Coleman, Abdulraheem Yacoub, Jason M. Melear, Suzanne R. Fanning, Kathryn S. Kolibaba, Chris Reynolds, Grzegorz S. Nowakowski, Mecide Gharibo, Jung Ryun Ahn, Ju Li, Mathias J. Rummel, Jeff P. Sharman

Research output: Contribution to journalArticlepeer-review

Abstract

Context: Patients with relapsed indolent NHL (iNHL) have limited standard treatment options. Lenalidomide + rituximab (R2) has shown complimentary clinical activity and is tolerable in both untreated and relapsed/refractory (R/R) iNHL. Design: MAGNIFY is a multicenter, phase 3b trial in R/R follicular lymphoma (FL) grades 1–3b, transformed FL (tFL), marginal zone lymphoma (MZL), or mantle cell lymphoma (MCL; NCT01996865). In the induction phase, lenalidomide 20mg PO d1–21 of a 28-d cycle + rituximab IV 375mg/m2/week cycle 1 and then q8w starting with cycle 3 (R2) are administered for 12 cycles. Patients with ≥SD were randomized 1:1 to R2 vs rituximab maintenance for 18 months. Data here are the complete induction phase analysis in efficacy-evaluable patients with FL grades 1–3a or MZL. The focus of this interim analysis was ORR by 1999 IWG criteria in the induction ITT population. Results: As of March 5th, 2021, 394 patients (318 [81%] FL gr1–3a; 76 [19%] MZL) were enrolled. Median follow-up was 40.6 mo (range, 0.6–79.6). Median age was 66 y (range, 35–91), 328 (83%) had stage III/IV disease, with a median of 2 prior therapies (94% prior rituximab-containing). ORR was 71% with 42% CR/CRu. All patients have completed R2 induction (n=232, 59%) or discontinued study treatment (n=162, 41%); 141 patients (36%) prematurely discontinued both lenalidomide and rituximab, primarily due to AEs (n=54, 14%) or PD (n=42, 11%). The majority who have completed induction have been randomized and entered maintenance (n=217). Median DOR in the induction period was NR (95% CI, 43.9 mo–NR); median PFS in the induction safety population was 50.5 mo (95% CI, 39.5–NR). Most common all-grade TEAEs were 47% fatigue, 43% neutropenia, 37% diarrhea. Grade 3/4 AEs occurring in ≥5% of patients included 37% neutropenia (10 patients [3%] had febrile neutropenia), 8% leukopenia, 6% thrombocytopenia, 5% anemia, 5% fatigue. Conclusions: These data represent a complete analysis of all patients in the induction phase of MAGNIFY that continue to support that R2 is active with a tolerable safety profile in patients with R/R FL grade 1–3a and MZL, including rituximab-refractory, double-refractory, and early relapse patients.

Original languageEnglish (US)
Pages (from-to)S384
JournalClinical Lymphoma, Myeloma and Leukemia
Volume22
DOIs
StatePublished - Oct 2022

Keywords

  • follicular lymphoma
  • IBCL
  • IMiD
  • marginal zone
  • Phase III
  • rituximab

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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