RELEVANCE: PHASE III EFFICACY AND SAFETY STUDY OF LENALIDOMIDE PLUS RITUXIMAB (R2) VERSUS RITUXIMAB PLUS CHEMOTHERAPY, FOLLOWED BY RITUXIMAB, IN PREVIOUSLY UNTREATED FOLLICULAR LYMPHOMA
Author(s): ,
Frank Morschhauser
Affiliations:
Department d' Hematologie,Centre Hospitalier Universitaire Régional de Lille, Unité GRITA,Lille,France
,
Nathan H. Fowler
Affiliations:
Department of Lymphoma and Myeloma,The University of Texas MD Anderson Cancer Center,Houston,United States
,
Pierre Feugier
Affiliations:
Centre Hospitalier Universitaire Régional de Nancy, Service d'Hématologie,Vandoeuvre les Nancy,France
,
Reda Bouabdallah
Affiliations:
Department d' Hematologie,Institut Paoli Calmettes,Marseille,France
,
Hervé Tilly
Affiliations:
Department d' Hematologie,Centre Henri Becquerel,Rouen,France
,
M. Lia Palomba
Affiliations:
Department of Medicine,Memorial Sloan Kettering Cancer Center,New York,United States
,
Christophe Fruchart
Affiliations:
Institut d'Hématologie de Basse Normandie,Caen,France
,
Edward N. Libby
Affiliations:
Department of Medicine,University of Washington,Seattle,United States
,
Rene-Olivier Casasnovas
Affiliations:
CHU Le Bocage Service d'Hématologie Clinique,Dijon,France
,
Ian Flinn
Affiliations:
Sarah Cannon Research Institute,Nashville,United States
,
Corinne Haioun
Affiliations:
Hôpital Henri Mondor Unité Hémopathies Lymphoïdes,Creteil,France
,
Hervé Maisonneuve
Affiliations:
CHD Vendée Service d'Onco-Hématologie,Cedex,France
,
Loic Ysebaert
Affiliations:
IUCT Oncopole Service d'Hématologie,Cedex,France
,
Nancy Bartlett
Affiliations:
Washington University School of Medicine, Siteman Cancer Center Hematology Labs,St. Louis,United States
,
Kamal Bouabdallah
Affiliations:
Hôpital Haut Lévêque - Centre François Magendie Service d'Hématologie Clinique et Thérapie Cellulaire,Cedex,France
,
Pauline Brice
Affiliations:
Hôpital Saint Louis Service d'Onco-Hématologie,Cedex,France
,
Vincent Ribrag
Affiliations:
Gustave Roussy Cancer,Cedex,France
,
Nicolas Daguindau
Affiliations:
Centre Hospitalier Annecy Genevois Service d'Hématologie,Cedex,France
,
Steven Le Gouill
Affiliations:
CHU de Nantes - Hôtel Dieu Service d'Hématologie Clinique,Nantes,France
,
Gian Matteo Pica
Affiliations:
CH Métropole Savoie Service Hématologie,Chambery,France
,
Alejandro Martin Garcia-Sancho
Affiliations:
Department of Hematology,Hospital Universitario de Salamanca and IBSAL, CIBERONC,Salamanca,Spain
,
Armando López Guillermo
Affiliations:
Department of Hematology,Hospital Clinic de Barcelona,Barcelona,Spain
,
Jean-François Larouche
Affiliations:
CHU de Québec, Hôpital de l'Enfant-Jésus,Québec,Canada
,
Kiyoshi Ando
Affiliations:
Department of Hematology and Oncology,Tokai University Hospital,Kanagawa,Japan
,
Maria Gomes da Silva
Affiliations:
Departamento de Hematologia,Instituto Português de Oncologia Lisboa Francisco Gentil (IPOLFG),Lisboa,Portugal
,
Marc Andre
Affiliations:
Hematology Department,CHU UCL Namur,Yvoir,Belgium
,
Pierre Zachée
Affiliations:
Department of Hematology,ZNA Stuivenberg,Antwer,Belgium
,
Laurie H. Sehn
Affiliations:
British Columbia Cancer Centre for Lymphoid Cancer, University of British Columbia ,Vancouver,Canada
,
Kensei Tobinai
Affiliations:
Department of Hematology,National Cancer Center Hospital,Tokyo,Japan
,
Guillaume Cartron
Affiliations:
Department of Hematology,CHU Montpellier, University of Montpellier,Montpellier,France
,
David Liu
Affiliations:
Celgene Corporation,Summit,United States
,
Jianming Wang
Affiliations:
Celgene Corporation,Summit,United States
,
Luc Xerri
Affiliations:
Departement de Bio-pathologie,Institut Paoli-Calmettes,Marseilles,France
Gilles A. Salles
Affiliations:
Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, University of Lyon,Pierre-Benite,France
(Abstract release date: May 17, 2018) EHA Learning Center. Morschhauser F. Jun 15, 2018; 215924
Topic: 3Af Follicular lymphoma
Franck Morschhauser
Franck Morschhauser
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Abstract
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Abstract: S154


 

Type: Presidential Symposium


 

Presentation during EHA23: On Friday, June 15, 2018 from 17:00 - 17:15


 

Location: Room A1


 

Background
Standard of care for advanced stage, high tumor burden, previously untreated follicular lymphoma (FL) has been rituximab plus chemotherapy (R-chemo) followed by rituximab maintenance. Combination immunotherapy with lenalidomide and rituximab (R2) is a chemotherapy-free regimen that has shown promising efficacy and safety in previously untreated patients with FL.


 

Aims
This is the first report of the co-primary endpoints: i) complete response (CR)/CR unconfirmed (CRu) at 120 weeks and ii) interim analysis of progression-free survival (PFS; ~50% of the target of 456 events by 1999 IWG criteria) for R2 vs R-chemo followed by rituximab in previously untreated patients with FL.


 

Methods
RELEVANCE is a global, randomized, open-label phase III trial (NCT01650701; EUDRACT2011-002792-42) in patients with grade 1-3a FL who required systemic therapy (per GELF criteria). In the R2 arm, lenalidomide 20 mg/day on days 2-22/28 was given cycles 1 to 6-12, continued in responders at 10 mg/day for a total of 18 cycles. Rituximab was 375 mg/m2 weekly in cycle 1, day 1 in cycles 2-6, and continued in responders for 12 additional cycles (q8wk). R-chemo was given per investigator’s choice of standard R-CHOP, R-bendamustine (R-B), or R-CVP, followed by 12 cycles of rituximab (q8wk).


 

Results
As of the cutoff date of 31May2017, 1030 patients with high tumor burden FL were randomized to R2 (n=513) or R-chemo (n=517; 72% R-CHOP, 23% R-B, 5% R-CVP). Both groups had similar baseline characteristics; overall median age was 59 years (range, 23-89), 49% with FLIPI score ≥3, 93% stage III/IV, and 41% bulky disease (>7 cm). The superiority of both co-primary endpoints for R2 over R-chemo was not established after a median follow-up of 37.9 months. CR/CRu at 120 weeks was similar in the R2 v R-chemo groups (48% v 53%, P=0.13 per central review; 55% v 58%, P=0.38 per investigator assessment). R2 and R-chemo groups demonstrated similar 3-year PFS rates by both central review (77% v 78%) and investigator assessment (77% v 78%), respectively (Figure). 3-year overall survival was 94% for both arms. The toxicity profiles for R2 v R-chemo were different, with lower rates of any grade fatigue (23% v 29%), nausea (20% v 42%), peripheral neuropathy (11% v 22%), vomiting (7% v 19%), stomatitis (3% v 7%), and alopecia (1% v 9%), and higher rates of cutaneous reactions (43% v 24%), diarrhea (37% v 19%), and tumor flare reaction (6% v 0.2%) associated with R2. Rates of thromboembolic events were similar in both groups. Higher grade 3/4 lab neutropenia (34% v 50%) and febrile neutropenia (2% v 6%) were associated with R-chemo, whereas higher grade 3/4 cutaneous reactions (7% v 1%) were associated with R2. Adverse events (AEs) led to treatment discontinuation in 11% of R2 and 3% of R-chemo patients. Grade 5 AEs were 1% for both arms, and SPMs were reported in 7% (n=38) R2 and 9% (n=48) R-chemo patients (5% invasive SPMs for both). 69% R2 and 71% R-chemo patients completed 30 months of treatment. For the R2 group, 76% of patients completed all 18 cycles of lenalidomide.


 


 

Conclusion
RELEVANCE is the first randomized phase III trial comparing the chemotherapy-free regimen R2 v standard R-chemo followed by rituximab maintenance in previously untreated patients with FL. The superiority of R2 over R-chemo was not demonstrated in this phase III trial, however, compared with R-chemo, R2 appeared to show similar efficacy with a different toxicity profile.


 

Session topic: 20. Indolent Non-Hodgkin lymphoma – Clinical



 
 

Keyword(s): Follicular lymphoma, Imids, Non-Hodgkin's lymphoma


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