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Attend this session at the
2018 ASCO Annual Meeting!


Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Type: Oral Abstract Session

Time: Sunday June 3, 9:45 AM to 12:45 PM

Location: E450

RELEVANCE: Phase III randomized study of lenalidomide plus rituximab (R2) versus chemotherapy plus rituximab, followed by rituximab maintenance, in patients with previously untreated follicular lymphoma.

Sub-category:
Non-Hodgkin Lymphoma

Category:
Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Meeting:
2018 ASCO Annual Meeting

Abstract No:
7500

Citation:
J Clin Oncol 36, 2018 (suppl; abstr 7500)

Author(s): Nathan Hale Fowler, Franck Morschhauser, Pierre Feugier, Reda Bouabdallah, Herve Tilly, Maria Lia Palomba, Christophe Fruchart, Edward N. Libby, Olivier Casasnovas, Maria Gomes Da Silva, Delphine Pranger, Pierre Zachee, Alejandro Martin Garcia-Sancho, Armando Lopez-Guillermo, Jean-Francois Larouche, Kiyoshi Ando, Dongfang Liu, Jianming Wang, Luc Xerri, Gilles A. Salles; The University of Texas MD Anderson Cancer Center, Houston, TX; Centre Hospitalier Universitaire Régional de Lille, Unité GRITA, Lille, France; CHU Brabois Service d'Hématologie et Médecine Interne, Vandoeuvre Les Nancy, France; Institut Paoli-Calmettes, Marseille, France; Centre Henri Becquerel, University of Rouen, Rouen, France; Memorial Sloan Kettering Cancer Center, New York, NY; Institut d'Hématologie de Basse Normandie, Caen, France; University of Washington, Seattle, WA; CHU Le Bocage Service d'Hématologie Clinique, Dijon, France; Instituto Português de Lisboa Francisco Gentil, IPOLFG-EPE Departamento Hematologia, Lisboa, Portugal; Grand Hôpital de Charleroi, Charleroi, Belgium; ZNA Stuivenberg, Antwerp, Belgium; Hospital Universitario de Salamanca and IBSAL, CIBERONC, Salamanca, Spain; Hospital Clínic de Barcelona, Barcelona, Spain; CHU de Quebec Hopital de l'Enfant-Jesus, Quebec, QC, Canada; Tokai University Hospital, Kanagawa, Japan; Celgene Corporation, Summit, NJ; Hospices Civils de Lyon, Université Lyon-1, Lyon, France

Abstract Disclosures

Abstract:

Background: Immunochemotherapy induction followed by rituximab maintenance is the standard of care in previously untreated symptomatic FL. Phase II studies of chemo-free combination immunotherapy with lenalidomide and rituximab (R2) show promising activity. Methods: RELEVANCE is a global, randomized, phase III trial (NCT01650701) of R2 vs R-chemo followed by rituximab in previously untreated grade 1-3a FL patients requiring therapy according to GELF criteria. Lenalidomide dose was 20 mg/d, d2-22/28 for 6-12 cycles (c), continued in responders at 10 mg/d for a total of 18 c. Rituximab dose was 375 mg/m2 weekly c1 and d1 c2-6 and continued in responders for 12 additional c (q8wk). R-chemo was given per investigator’s choice of standard R-CHOP, R-bendamustine (R-B), or R-CVP, followed by 12 c of rituximab (q8wk). Co-primary endpoints of CR/CRu at 120 wk and PFS (50% interim analysis by 1999 IWG) are reported here. Results: As of 31May2017, 1030 patients with high tumor burden were randomized to R2 (n = 513) and R-chemo (n = 517; 72% R-CHOP, 23% R-B, 5% R-CVP); baseline characteristics were similar in both groups. At a median follow-up of 37.9 mo, superiority for R2 over R-chemo was not established for both co-primary endpoints (Table). Toxicity profiles for R2 vs R-chemo differed, with higher grade 3/4 lab (34% vs 50%) and febrile (2% vs 6%) neutropenia with R-chemo, and higher grade 3/4 cutaneous events (7% vs 1%) with R2. SPMs were reported in 7% R2 and 9% R-chemo patients and grade 5 AEs were 1% for both. 69% R2 and 71% R-chemo patients completed treatment. Conclusions: In the first randomized phase III comparison of a chemo-free regimen vs standard R-chemo followed by rituximab maintenance in previously untreated FL, R2 showed similar efficacy and a different safety profile to R-chemo. Clinical trial information: NCT01650701

Primary efficacy results of R2 vs R-chemo in previously untreated FL.

R2 (n = 513)R-chemo (n = 517)P value
CR/CRu at 120 wk
By IRC48%53%0.13
By Inv55%58%0.38
PFS
R2 vs R-chemo: HR (95% CI) by IRC1.10 (0.85, 1.43)0.48
R2 vs R-chemo: HR (95% CI) by Inv0.94 (0.73, 1.22)0.63
2 y (IRC/Inv)84%/84%87%/83%
3 y (IRC/Inv)77%/77%78%/78%
OS at 3 y94%94%

 
Other Abstracts in this Sub-Category:

 

1. Treatment approach for non-Hodgkin lymphoma patients since first biosimilars of rituximab approved in EU5.

Meeting: 2018 ASCO Annual Meeting Abstract No: 112 First Author: Alessandra Franceschetti
Category: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia - Non-Hodgkin Lymphoma

 

2. Acalabrutinib in patients (pts) with Waldenström macroglobulinemia (WM).

Meeting: 2018 ASCO Annual Meeting Abstract No: 7501 First Author: Roger Owen
Category: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia - Non-Hodgkin Lymphoma

 

3. Activity and tolerabilty of the first-in-class anti-CD47 antibody Hu5F9-G4 with rituximab tolerated in relapsed/refractory non-Hodgkin lymphoma: Initial phase 1b/2 results.

Meeting: 2018 ASCO Annual Meeting Abstract No: 7504 First Author: Ranjana H. Advani
Category: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia - Non-Hodgkin Lymphoma

 

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