PATIENTS WITH RELAPSED/REFRACTORY INDOLENT NON-HODGKIN LYMPHOMA WERE MORE SENSITIVE TO NEXT TREATMENT FOLLOWING LENALIDOMIDE/RITUXIMAB (R2) THAN RITUXIMAB/PLACEBO (AUGMENT)
Author(s): ,
John Gribben
Affiliations:
Centre for Haemato-Oncology, Barts Cancer Institute,London,United Kingdom
,
Marek Trneny
Affiliations:
Charles University, General Hospital,Prague,Czech Republic
,
Koji Izutsu
Affiliations:
National Cancer Center Hospital,Tokyo,Japan
,
Nathan H. Fowler
Affiliations:
The University of Texas MD Anderson Cancer Center,Houston,United States
,
Xiaonan Hong
Affiliations:
Fudan University Shanghai Cancer Center, Shanghai,China
,
Huilai Zhang
Affiliations:
Tianjin Medical University Cancer Institute and Hospital,Tianjin,China
,
Fritz Offner
Affiliations:
UZ Gent,Gent,Belgium
,
Adriana Scheliga
Affiliations:
INCA Instituto Nacional De Câncer,Rio de Janeiro,Brazil
,
Grzegorz Nowakowski
Affiliations:
Mayo Clinic,Rochester,United States
,
Antonio Pinto
Affiliations:
Istituto Nazionale Tumori, Fondazione ‘G. Pascale’, IRCCS,Naples,Italy
,
Francesca Re
Affiliations:
Azienda Ospedaliero Universitaria di Parma,Parma,Italy
,
Laura Maria Fogliatto
Affiliations:
Hospital de Clinicas de Porto Alegre, Porto Alegre,Brazil
,
Phillip Scheinberg
Affiliations:
Hospital A Beneficência Portuguesa de São Paulo,São Paulo,Brazil
,
Ian Flinn
Affiliations:
Sarah Cannon Research Institute/Tennessee Oncology,Nashville,United States
,
Claudia Moreira
Affiliations:
Instituto Português de Oncologia Do Porto Francisco Gentil Epe,Porto,Portugal
,
Myron Czuczman
Affiliations:
Celgene Corporation,Summit,United States
,
Stacey A. Kalambakas
Affiliations:
Celgene Corporation,Summit,United States
,
Pierre Fustier
Affiliations:
Celgene Corporation,Boudry,Switzerland
,
Chengqing Wu
Affiliations:
Celgene Corporation,Summit,United States
John P. Leonard
Affiliations:
Meyer Cancer Center, Weill Cornell Medicine and New York Presbyterian Hospital,New York,United States
EHA Library. Gribben J. Jun 15, 2019; 266869; PS1252
Prof. Dr. John Gribben
Prof. Dr. John Gribben
Contributions
Abstract

Abstract: PS1252

Type: Poster Presentation

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

Location: Poster area

Background
An unmet need remains in patients with indolent lymphoma following relapse; more effective and tolerable therapies are needed to improve outcomes. Although most patients experience shortened remission periods with subsequent lines of therapy, it is proposed that lenalidomide + rituximab (R2) may improve the efficacy of next treatment through their unique mechanisms of action.

Aims
The objective of this analysis was to evaluate the sensitivity of patients to their next treatment following R2 or R/placebo.

Methods
AUGMENT is a multicenter, international phase III study evaluating patients with relapsed/refractory (R/R) follicular lymphoma (FL) grade 1-3a and marginal zone lymphoma (MZL) after ≥ 1 prior systemic therapy (but were not rituximab refractory). Patients were randomized 1:1 to R2 (lenalidomide PO 20 mg/d, d1-21/28 X12 cycles + rituximab [R] IV 375 mg/m2/wk, cycle 1, d1, 8, 15, 22 and cycles 2-5, d1) and R/placebo (same dosing schedule). Progression-free survival (PFS; primary endpoint) and response were assessed by 2007 IWG criteria (without PET); secondary/exploratory endpoints included time to next antilymphoma/chemotherapy treatment (TTNLT/TTNCT) and response to next treatment. TTNLT/TTNCT was defined as time from randomization to date of the next antilymphoma/chemotherapy treatment. Per regulatory guidance, PFS2 was defined as time from randomization to first PD or death from any cause after next antilymphoma treatment, or initiation of a third antilymphoma treatment.

Results
Of 358 randomized patients (n = 178 R2; n = 180 R/placebo), 82% were FL grade 1-3a and 18% MZL; median age was 63 y, 34% had FLIPI score ≥ 3, and patients had received a median of 1 (range, 1-12) prior systemic therapy (84% prior rituximab). The primary endpoint was met; median PFS was superior for R2 over R/placebo (39.4 vs 14.1 mo; HR = 0.46; P < 0.0001). As of 22June2018, the medians for TTNLT, TTNCT, and PFS2 were not reached for R2, and were significantly longer than R/placebo (HR = 0.54 [95% CI, 0.38-0.78], 0.50 [95% CI, 0.32-0.78], and 0.52 [95% CI, 0.32-0.82], respectively). For 49/178 (28%) R2 and 80/180 (44%) R/placebo patients who received a next antilymphoma therapy, results for subsequent responses were generally higher with R2 (57% ORR; 31% CR) than R/placebo (36% ORR; 16% CR; Table).

Conclusion
In these analyses of patients with R/R FL grade 1-3a and MZL, patients receiving R2 showed prolonged time to subsequent treatment, which was associated with longer PFS2 compared with R/placebo, enabling greater responses to next therapy. Based on a modest numbers of patients, it is hypothesized that patients were generally more sensitive to subsequent therapy after R2 than R/placebo.

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

Keyword(s): Follicular lymphoma, Imids, Marginal zone, Rituximab

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