EFFICACY WAS IMPROVED WITH LENALIDOMIDE/RITUXIMAB (R2) VS RITUXIMAB/PLACEBO IN PATIENTS WITH FOLLICULAR LYMPHOMA IRRESPECTIVE OF POD24 STATUS IN THE PHASE III AUGMENT STUDY
Author(s): ,
John P. Leonard
Affiliations:
Meyer Cancer Center, Weill Cornell Medicine and New York Presbyterian Hospital,New York,United States
,
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 Gribben
Affiliations:
Centre for Haemato-Oncology, Barts Cancer Institute,London,United Kingdom
EHA Library. Leonard J. Jun 14, 2019; 266283; PF483
John Leonard
John Leonard
Contributions
Abstract

Abstract: PF483

Type: Poster Presentation

Presentation during EHA24: On Friday, June 14, 2019 from 17:30 - 19:00

Location: Poster area

Background
Less favorable prognosis and survival have been reported for follicular lymphoma (FL) patients who relapse within 2 years of initial chemoimmunotherapy (ie, POD24; Casulo et al. Blood. 2019).

Aims
The objective of this analysis was to evaluate the potential impact of POD24 on efficacy in the randomized phase III AUGMENT study of lenalidomide/rituximab (R2) vs rituximab/placebo (R/placebo).

Methods
Patients had relapsed/refractory (R/R) FL grade 1-3a after ≥ 1 prior systemic therapy, but were not refractory to rituximab. R2 treatment was lenalidomide PO 20 mg/day (d), d1-21/28 X12 cycles plus rituximab IV 375 mg/m2 given cycle 1, d1, 8, 15, 22 and d1, cycles 2-5. Rituximab and placebo control were given on the same schedule. The primary endpoint was progression-free survival (PFS) per 2007 IWG (without PET) by independent central review. POD24 was defined post-hoc as progression or relapse within 2 years of initial antilymphoma treatment, which included immuno- and/or chemotherapy.  

Results
As of 22June2018, 147 FL grade 1-3a patients were randomized to R2 and 148 to R/placebo. FL patients had a median age of 62 years (range, 26-88), 74% with Ann Arbor stage III/IV disease, 34% high FLIPI score, 84% received prior rituximab, and 53% prior antilymphoma treatment within 2 years of enrollment. 56 (38%) R2 and 57 (39%) R/placebo patients were identified as relapsing/progressing within 2 years of initial treatment (POD24). Median PFS was improved in patients receiving R2 vs R/placebo, irrespective of POD24 status (R2 vs R/placebo: HR = 0.41 [95% CI, 0.24-0.68] with POD24 and HR = 0.43 [95% CI, 0.28-0.65] with no POD24; Table). Best responses (ORR and CR) were similar within each arm in patients with or without POD24. Treatment with R2 (vs R/placebo) reduced the risk of relapse/progression by 59% in patients with POD24, and improved both ORR and CR. Similar outcomes were shown for patients who relapsed within 2 years from diagnosis (data not shown). 

Conclusion
The efficacy of R2 was superior over R/placebo in patients with FL grade 1-3a. Improvements with R2 were evident in the subgroup of patients with POD24, patients who have historically been associated with less favorable outcomes. 

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

Keyword(s): Follicular lymphoma, Imids, Rituximab

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