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Clinical Trial
. 2025 Jul 22;9(14):3530-3539.
doi: 10.1182/bloodadvances.2024015226.

Atezolizumab consolidation in patients with high-risk diffuse large B-cell lymphoma in complete remission after R-CHOP

Marcel Nijland  1 , Djamila E Issa  2 , Johanna A A Bult  1 , Dries Deeren  3 , Gerjo A Velders  4 , Marten R Nijziel  5 , Yorick Sandberg  6 , Vibeke Vergote  7 , Margriet Oosterveld  8 , Rob Fijnheer  9 , Rolf E Brouwer  10 , Rinske S Boersma  11 , Kalung Wu  12 , Laurens Nieuwenhuizen  13 , Joost S P Vermaat  14 , Roel J W van Kampen  15 , Wim E Terpstra  16 , Sylvia Snauwaert  17 , Marjolein W van der Poel  18 , Eva de Jongh  19 , Marc F Durian  20 , Leonie Strobbe  21 , Aart Beeker  22 , Alain Gadisseur  23 , Roos S van Rijn  24 , Otto Visser  25 , Jeanette K Doorduijn  26 , Tjeerd J F Snijders  27 , Matthijs H Silbermann  28 , Daphne de Jong  29 , Martine Chamuleau  30 , Rogier Mous  31 , Hilde Jalving  32 , Heleen Visser-Wisselaar  33 , Sonja Jansen van de Bergh  33 , Gerben J C Zwezerijnen  34 , Edwin Bremer  1 , Mirian Brink  35 , Arjan Diepstra  36 , Dana A Chitu  26   33 , Harry R Koene  37 , Josée M Zijlstra  30
Affiliations
Clinical Trial

Atezolizumab consolidation in patients with high-risk diffuse large B-cell lymphoma in complete remission after R-CHOP

Marcel Nijland et al. Blood Adv. .

Abstract

The risk of relapse among high-risk patients with diffuse large B-cell lymphoma (DLBCL) in complete metabolic remission (CMR) after rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) therapy is 20% to 25%. Here, we evaluated whether consolidation with the programmed cell death ligand 1 checkpoint inhibitor atezolizumab could reduce the relapse risk. In this phase 2, open-label trial, patients with DLBCL with an International Prognostic Index (IPI) score of ≥3 and CMR after R-CHOP received 1200 mg atezolizumab every 3 weeks for 18 cycles. The primary end point was disease-free survival (DFS) at 2 years, with the aim of improving it to 89% compared to historical 79%. Secondary end points included overall survival (OS) and safety (Common Terminology Criteria for Adverse Events version 4.0). Analyses were on an intention-to-treat principle. Of 109 patients, 65% completed treatment. The cohort was 59% males, with 63% having high-intermediate risk IPI scores. At a median follow-up of 36.4 months, 15 relapses occurred (median, 8.2 months). The 2-year DFS was 87.9% (90% confidence interval [CI], 81.5-92.1), and the 2-year OS was 96.3% (90% CI, 91.7-98.3), meeting the primary objective. Treatment with salvage chemotherapy resulted in 10 of 13 patients achieving a second CMR. OS was significantly better among atezolizumab-treated patients than in a population-based matched control cohort from the Netherlands Cancer Registry. Adverse events (AEs) affected 79% of patients, with 18% developing immune-related AEs, including 4.5% grade 3 to 4. Atezolizumab consolidation significantly improved DFS in high-risk patients with DLBCL compared to historical cohorts. OS was significantly better than a population-based control cohort. These findings warrant further validation and assessment of immune checkpoint inhibitors as consolidation strategy in DLBCL. This trial was registered at www.clinicaltrials.gov as #NCT03463057.

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Conflict of interest statement

Conflict-of-interest disclosure: M.N. reports research support from Takeda; travel support from AbbVie; and participation in data safety monitoring board or advisory board for AbbVie. M.C. declares research support from Bristol Myers Squibb, Gilead, and Genmab, and participation on advisory boards for AbbVie, Novartis, and Incyte. The remaining authors declare no competing financial interests.

Figures

None
Graphical abstract
Figure 1.
Figure 1.
Depiction of adherence to the prespecified treatment protocol and delineation of factors contributing to noncompletion of atezolizumab consolidation in a cohort of 109 patients diagnosed with high-risk DLBCL in complete remission.
Figure 2.
Figure 2.
Survival curves for high-risk DLBCL patients treated with atezolizumab consolidation. Disease free survival (A) and overall survival (B) outcomes observed in 109 patients diagnosed with high-risk DLBCL who achieved complete remission and were treated with atezolizumab for up to 54 weeks.
Figure 3.
Figure 3.
Representation of AEs occurring at a prevalence of >2% among 109 patients diagnosed with high-risk DLBCL in complete remission, treated with atezolizumab for up to 54 weeks.
Figure 4.
Figure 4.
Temporal dynamics of MRD in 10 patients with high-risk DLBCL who experienced relapse during or after atezolizumab treatment. MRD assessment was performed using the clonoSEQ assay on cell-free DNA samples. MRD status is determined as either positive or negative based on the limit of detection (LOD) of the assay, which is individually calculated for each sample. The LOD represents the lowest level of residual tracked templates that can be reliably detected in at least 95% of samples.
Figure 5.
Figure 5.
OS of patients diagnosed with high-risk DLBCL treated with atezolizumab consolidation and a 1:1 matched population-based control group from the NCR. IKNL, Netherlands Comprehensive Cancer Organization; R-CHOP, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone.
See this image and copyright information in PMC

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