A Phase 2 Study of Obinutuzumab Combined With Lenalidomide in Previously Untreated High Tumor Burden Follicular Lymphoma

Authors

Neha Akkad
Lei Feng
Jason R Westin
Fredrick B Hagemeister
Hun Ju Lee
Luis Fayad
Sairah Ahmed
Ranjit Nair
Maria Alma Rodriguez
Paolo Strati
Dai Chihara
Christopher R Flowers
Linda Claret
Karina Ibanez
Michael Wang
Nathan H Fowler
Jared Henderson
R Eric Davis
Sattva S Neelapu
Michael Green
Loretta J Nastoupil

Publication Date

9-9-2025

Journal

Blood Advances

DOI

10.1182/bloodadvances.2025016483

PMID

40517417

PMCID

PMC12405678

PubMedCentral® Posted Date

6-17-2025

PubMedCentral® Full Text Version

Post-print

Abstract

Follicular lymphoma (FL) has a clinical course that is often characterized by high response rates to first-line therapy, followed by multiple relapses over a prolonged natural history. Currently, there are multiple possible approaches to frontline therapy for untreated advanced-stage FL, but there is an ongoing debate around what is the preferred approach. Based on the benefits seen with combining lenalidomide, an immunomodulatory agent, with rituximab, an anti-CD20 antibody, we aimed to evaluate the safety and efficacy of lenalidomide in combination with obinuzutumab, an anti-CD20 antibody with enhanced antibody-dependent cellular cytotoxicity. The eligibility criteria included a diagnosis of FL, grade 1 to 3a, stage II to IV, Eastern Cooperative Oncology Group performance status ≤ 2, adequate organ function, and high tumor burden according to the Groupe d'Étude des Lymphomes Folliculaires criteria. Participants received 6 cycles of induction with the combination, followed by 24 cycles of maintenance. Among 90 patients, the primary end point, 2-year progression-free survival (PFS), was 93.3% (95% confidence interval [CI], 88.2-98.6), and the median PFS was not reached with a median follow-up of 70.7 months. The complete response rate at 30 months was 89.7% (95% CI, 81.3-95.2). The most common adverse events (AEs) of any grade were diarrhea (61.1%), maculopapular rash (53.3%), and fatigue (52.2%). The most common AEs ≥ grade 3 were neutropenia (18.9%), maculopapular rash (11.1%), and pneumonia (6.7%). In this single-center trial, these findings indicate that, for patients with previously untreated, high tumor burden FL, obinutuzumab and lenalidomide led to robust and durable responses with a favorable 2-year PFS and manageable safety profile. This trial was registered at www.clinicaltrials.gov as #NCT02871219.

Keywords

Humans, Lenalidomide, Lymphoma, Follicular, Antibodies, Monoclonal, Humanized, Female, Male, Middle Aged, Aged, Antineoplastic Combined Chemotherapy Protocols, Adult, Tumor Burden, Aged, 80 and over, Treatment Outcome

Published Open-Access

yes

Recommended Citation

Akkad, Neha; Feng, Lei; Westin, Jason R; et al., "A Phase 2 Study of Obinutuzumab Combined With Lenalidomide in Previously Untreated High Tumor Burden Follicular Lymphoma" (2025). Faculty, Staff and Student Publications. 4902.
https://digitalcommons.library.tmc.edu/uthgsbs_docs/4902