EHA Library - The official digital education library of European Hematology Association (EHA)

Abstract

Abstract: P634

Type: Poster Presentation

Presentation during EHA22: On Saturday, June 24, 2017 from 17:30 - 19:00

Location: Poster area (Hall 7)

Background
Lenalidomide is an immunomodulatory agent with direct and immune-mediated mechanisms of action, and clinical activity in indolent non-Hodgkin lymphoma (NHL). Recent studies in frontline and relapsed/refractory (R/R) iNHL show tolerability and high activity for the combination of lenalidomide plus rituximab (R2) and support further study of R2.

Aims
The current study evaluates the efficacy and safety of R2 induction in patients with R/R follicular lymphoma (FL).

Methods
MAGNIFY (NCT01996865) is a Phase IIIb, multicenter, open-label study of R/R NHL patients, including grades 1-3b and transformed follicular lymphoma (tFL). Upon informed consent, patients receive 12 cycles of R2 induction (lenalidomide 20 mg/d, 21 of 28 d; rituximab 375 mg/m2 weekly cycle 1 [d1, 8, 15, 22], then d1 of odd cycles). Responders to induction (≥SD) are randomized 1:1 to maintenance with either R2 or rituximab alone (18 cycles); following R2 maintenance, optional single-agent lenalidomide (10 mg/d, 21 of 28 d) can be given until PD. The primary endpoint is progression-free survival (PFS).

Results
As of April 14, 2016, 106 patients with R/R FL have been enrolled, including 103 with grade 1-3a FL, 2 with tFL, and 1 unknown grade. Median age of patients with FL was 66 y (range, 41-91); most had ECOG PS of 0-1 (99%) and stage III/IV disease at study entry (80%). Patients received a median of 2 prior therapies (>2, 30%); 103 (97%) patients had received prior rituximab-containing treatment, of which 35% were rituximab refractory (defined as best response of SD/PD to rituximab/rituximab-containing regimen or a CR/PR of <6 mo after the last rituximab dose). The most common prior regimens were rituximab alone (40%), R-CHOP/R-CHOP–like (38%), and bendamustine plus rituximab (35%). Premature discontinuation of lenalidomide and/or rituximab occurred in 39 (37%) patients during the induction period, mainly due to AEs (n=20); the most common treatment-related AE leading to early discontinuation in the induction period was neutropenia in 6 patients. Four (4%) patients discontinued the study. Common grade 3/4 treatment-emergent AEs during induction in the FL safety population (n=104) were 27% neutropenia, 7% leukopenia, and 6% fatigue. At a median induction duration of 23 weeks (range, 0.4-51), 83 FL patients were evaluable for response with an overall response rate (ORR) of 65%; those who were not rituximab refractory had improved ORR compared to rituximab-refractory patients (70% vs 55%; Table 1). The median time to response during induction was 2.8 mo. Twenty patients have completed 12 cycles of induction and 16 proceeded to maintenance (n=6 R2, n=10 rituximab alone). Enrollment is ongoing.

Conclusion
R2 induction therapy shows favorable activity and a tolerable safety profile in patients with advanced-stage, R/R FL. The study is ongoing to determine the effect of R2 vs. rituximab maintenance in FL patients, and updated results will be presented.

Session topic: 19. Indolent Non-Hodgkin lymphoma - Clinical

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

Abstract: P634

Type: Poster Presentation

Presentation during EHA22: On Saturday, June 24, 2017 from 17:30 - 19:00

Location: Poster area (Hall 7)

Background
Lenalidomide is an immunomodulatory agent with direct and immune-mediated mechanisms of action, and clinical activity in indolent non-Hodgkin lymphoma (NHL). Recent studies in frontline and relapsed/refractory (R/R) iNHL show tolerability and high activity for the combination of lenalidomide plus rituximab (R2) and support further study of R2.

Aims
The current study evaluates the efficacy and safety of R2 induction in patients with R/R follicular lymphoma (FL).

Methods
MAGNIFY (NCT01996865) is a Phase IIIb, multicenter, open-label study of R/R NHL patients, including grades 1-3b and transformed follicular lymphoma (tFL). Upon informed consent, patients receive 12 cycles of R2 induction (lenalidomide 20 mg/d, 21 of 28 d; rituximab 375 mg/m2 weekly cycle 1 [d1, 8, 15, 22], then d1 of odd cycles). Responders to induction (≥SD) are randomized 1:1 to maintenance with either R2 or rituximab alone (18 cycles); following R2 maintenance, optional single-agent lenalidomide (10 mg/d, 21 of 28 d) can be given until PD. The primary endpoint is progression-free survival (PFS).

Results
As of April 14, 2016, 106 patients with R/R FL have been enrolled, including 103 with grade 1-3a FL, 2 with tFL, and 1 unknown grade. Median age of patients with FL was 66 y (range, 41-91); most had ECOG PS of 0-1 (99%) and stage III/IV disease at study entry (80%). Patients received a median of 2 prior therapies (>2, 30%); 103 (97%) patients had received prior rituximab-containing treatment, of which 35% were rituximab refractory (defined as best response of SD/PD to rituximab/rituximab-containing regimen or a CR/PR of <6 mo after the last rituximab dose). The most common prior regimens were rituximab alone (40%), R-CHOP/R-CHOP–like (38%), and bendamustine plus rituximab (35%). Premature discontinuation of lenalidomide and/or rituximab occurred in 39 (37%) patients during the induction period, mainly due to AEs (n=20); the most common treatment-related AE leading to early discontinuation in the induction period was neutropenia in 6 patients. Four (4%) patients discontinued the study. Common grade 3/4 treatment-emergent AEs during induction in the FL safety population (n=104) were 27% neutropenia, 7% leukopenia, and 6% fatigue. At a median induction duration of 23 weeks (range, 0.4-51), 83 FL patients were evaluable for response with an overall response rate (ORR) of 65%; those who were not rituximab refractory had improved ORR compared to rituximab-refractory patients (70% vs 55%; Table 1). The median time to response during induction was 2.8 mo. Twenty patients have completed 12 cycles of induction and 16 proceeded to maintenance (n=6 R2, n=10 rituximab alone). Enrollment is ongoing.

Conclusion
R2 induction therapy shows favorable activity and a tolerable safety profile in patients with advanced-stage, R/R FL. The study is ongoing to determine the effect of R2 vs. rituximab maintenance in FL patients, and updated results will be presented.

Session topic: 19. Indolent Non-Hodgkin lymphoma - Clinical

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

By clicking “Accept Terms & all Cookies” or by continuing to browse, you agree to the storing of third-party cookies on your device to enhance your user experience and agree to the user terms and conditions of this learning management system (LMS).

Cookie Settings
Accept Terms & all Cookies