MAGNIFY: PHASE IIIB INTERIM ANALYSIS OF INDUCTION R2 FOLLOWED BY MAINTENANCE IN PATIENTS WITH RELAPSED/REFRACTORY INDOLENT NON-HODGKIN LYMPHOMA
Author(s): ,
Mathias J. Rummel
Affiliations:
Justus-Liebig Universität,Giessen,Germany
,
David Jacob Andorsky
Affiliations:
Rocky Mountain Cancer Centers, US Oncology Research,Boulder,United States
,
Morton Coleman
Affiliations:
Clinical Research Alliance Inc, Weill Cornell Medicine,New York,United States
,
Abdulraheem Yacoub
Affiliations:
University of Kansas Cancer Center,Westwood,United States
,
Jason M. Melear
Affiliations:
Texas Oncology - Austin, US Oncology Research,Austin,United States
,
Suzanne R. Fanning
Affiliations:
Greenville Health System, US Oncology Research,Greenville,United States
,
Kathryn S. Kolibaba
Affiliations:
Compass Oncology, US Oncology Research,Vancouver,United States
,
Frederick Lansigan
Affiliations:
Dartmouth-Hitchcock Medical Center,Lebanon,United States
,
Chris Reynolds
Affiliations:
IHA Hematology Oncology Consultants - Ann Arbor,Ypsilanti,United States
,
Ken Foon
Affiliations:
Celgene Corporation,Summit,United States
,
Jiahui Li
Affiliations:
Celgene Corporation,Summit,United States
,
Mary Llorente
Affiliations:
Celgene Corporation,Summit,United States
Jeff Sharman
Affiliations:
Willamette Valley Cancer Institute and Research Center, US Oncology Research,Eugene,United States
EHA Library. J. Rummel M. Jun 15, 2019; 266870; PS1253
Mathias J. Rummel
Mathias J. Rummel
Contributions
Abstract

Abstract: PS1253

Type: Poster Presentation

Presentation during EHA24: On Saturday, June 15, 2019 from 17:30 - 19:00

Location: Poster area

Background
There is a lack of standard treatment approaches for patients with relapsed indolent non-Hodgkin lymphoma (iNHL). Current study results with PI3K inhibitors have reported a median PFS of < 1 y in the relapsed/refractory setting (R/R) for patients with iNHL. Lenalidomide, an immunomodulatory agent, enhances the activity of rituximab when combined into a regimen known as R2, which has recently reported a median PFS of 39.4 mo in patients with R/R iNHL patients from the phase III AUGMENT study (Leonard. ASH 2018:445).

Aims
These analyses examine the interim primary endpoint of overall response rate (ORR; 1999 IWG) for induction R2 in efficacy-evaluable patients receiving ≥ 1 treatment and who have available baseline and post-baseline assessments.

Methods
The multicenter, non-registrational phase IIIb MAGNIFY trial in patients with R/R follicular lymphoma (FL) grade 1-3a and marginal zone lymphoma (MZL) was designed to determine the optimal duration of lenalidomide (NCT01996865). R2 treatment includes lenalidomide 20 mg/d, d1-21/28 plus rituximab 375 mg/m2/wk cycle 1 and q8wk cycles 3+ given for 12 cycles, and is followed by 1:1 randomization in patients with stable disease or better to continued R2 vs rituximab maintenance.

Results
370 enrolled patients (80% FL grade 1-3a; 20% MZL) had a median age of 66 y, 83% stage III/IV disease, and a median of 2 prior therapies (95% prior rituximab-containing). At a median 16.7 mo follow-up, efficacy-evaluable patients demonstrated a 73% ORR and 45% complete response (CR; Table). Similar efficacy results were shown for patients by histology. Overall, the median time to response (TTR) was 2.7 mo, median duration was response (DOR) was 36.8 mo, and median progression-free survival (PFS) was 36.0 mo. According to their refractory status to rituximab at baseline, patients who were rituximab-refractory and non-refractory, respectively, had an ORR (CR) of 63% (40%) and 78% (47%), and median PFS of 18.1 mo and not reached. Of 370 patients who were randomized, 142 (38%) have entered the maintenance phase. The most common all-grade adverse events were 48% fatigue, 40% neutropenia, 35% diarrhea, 30% nausea, and 29% constipation. Although the grade 3/4 adverse event neutropenia was 34%, all others were < 6%.

Conclusion
R2 therapy is an active treatment regimen in patients with R/R FL grade 1-3a and MZL, including patients refractory to rituximab, and with a tolerable safety profile.

Session topic: 18. Indolent and mantle-cell non-Hodgkin lymphoma - Clinical

Keyword(s): Follicular lymphoma, Rituximab

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