Nivolumab plus brentuximab vedotin for relapsed/refractory diffuse large B-cell lymphoma - Research article - Results on CheckMate 436

Sep 29, 2026

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Up to 40% of diffuse large B-cell lymphoma patients develop relapsed or refractory disease after first-line rituximab-based chemoimmunotherapy, with poor outcomes after hematopoietic stem cell transplantation failure. CheckMate 436 (NCT02581631) evaluated nivolumab, a PD-1/PD-L1 inhibitor, combined with brentuximab vedotin in relapsed/refractory non-Hodgkin lymphoma. For the R/R DLBCL cohort (n=42), median follow-up was 7.7 months, ORR was 28.6% and complete responses were 7.1%. All patients had adverse events, predominantly diarrhea, and no new safety signals emerged. Overall efficacy did not support the combination for R/R DLBCL.

LanguageEnglish

CategoryHealthcare

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Pages7

Reading Time18 min

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Abstract

Aims

Materials and methods

Results

Conclusions

Introduction

FUTURE ONCOLOGY 2026, VOL. 22, NO. 1, 93–99 [https://doi.org/10.1080/14796694.2025.2599082](https://doi.org/10.1080/14796694.2025.2599082) | RESEARCH ARTICLE
Nivolumab plus brentuximab vedotin for relapsed/refractory diffuse large B-cell lymphoma
Nathalie A. Johnsona, Pier Luigi Zinzanib,c, Eva Domingo-Domenechd, Joshua Brodye, Justin Klinef, Bijal Dinesh Shahg, Amitkumar Nitinkumar Mehtah, Herve Ghesquieresi, Kerry J. Savagej, Paul M. Barrk, Armando Santorol, Silvia Ferrarim, David Cunninghamn, Graham P. Collinso, Michelle Fanalep, Jennifer Krajewskiq, Alev Akyolq, Russell Crower*, Rachael Wenq and John Kuruvillas
aDepartment of Medicine, Division of Hematology, Jewish General Hospital, Montreal, QC, Canada; bIRCCS Azienda Ospedaliero-Universitaria di Bologna Istituto di Ematologia “Seràgnoli”, Bologna, Italy; cDipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy; dInstitut Catala d’Oncologia, Hospital Duran i Reynals, IDIBELL, Barcelona, Spain; eMount Sinai School of Medicine, New York, NY, USA; fUniversity of Chicago, Chicago, IL, USA; gMoffitt Cancer Center, Tampa, FL, USA; hUniversity of Alabama at Birmingham, Birmingham, AL, USA; iHopital Lyon Sud, Pierre-Bénite, France; jBritish Columbia Cancer Agency, Vancouver, BC, Canada; kUniversity of Rochester, Rochester, NY, USA; lIRCCS Humanitas Research Hospital, Humanitas University, Milan, Italy; mOspedale Papa Giovanni XXIII, Bergamo, Italy; n Royal Marsden Hospital, London, UK; oChurchill Hospital, Oxford, UK; pPfizer Inc., Bothell, WA, USA; qBristol Myers Squibb, Princeton, NJ, USA; rBristol Myers Squibb, Boudry, Switzerland; sPrincess Margaret Cancer Centre, Toronto, ON, Canada | | | | --- | --- | --- | | ABSTRACT
Aims: Up to 40% of patients with diffuse large B-cell lymphoma (DLBCL) have relapsed or refractory (R/R) disease after first-line treatment with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone, and outcomes are poor after hematopoietic stem cell transplantation failure. CheckMate 436 (NCT02581631) was a phase 1/2 study to evaluate the efficacy and safety of nivolumab, a PD-1/PD-L1 inhibitor, plus brentuximab vedotin (BV) for the treatment of R/R non-Hodgkin lymphoma.
Materials and methods: Adult patients received nivolumab plus BV in 3-week cycles. The primary endpoint was overall response rate (ORR). Here, we report the results from the R/R DLBCL cohort (n = 42). Results: With a median follow-up of 7.7 months, the ORR was 28.6%(n = 12), and 7.1%(n = 3) of patients achieved a complete response. Median duration of response (95% CI) was 3.6 (1.2–36.5) months. All patients experienced an adverse event (AE), most commonly diarrhea (n = 20, 47.6%) . Grade 3/4 and 5 AEs occurred in 24 (57.1%) and 4 (9.5%) patients, respectively. Any-grade treatmentrelated AEs occurred in 35 (83.3%) patients. No new safety signals were identified.
Conclusions: Overall, the efficacy data from CheckMate 436 do not support the use of nivolumab plus BV for the treatment of R/R DLBCL. | | ARTICLE HISTORY
Received 23 May 2025 Accepted 1 December 2025
KEYWORDS
Diffuse large B-cell lymphoma; nivolumab; brentuximab vedotin; best overall response; immune checkpoint inhibitor; safety | | 1. Introduction | exhibited modest clinical activity in R/R DLBCL, with an | | | Approximately 30–40% of patients with diffuse large B-cell | overall response rate (ORR) of 36%[12]; ORR was 10% and | | | lymphoma (DLBCL) have relapsed or refractory (R/R) disease | 3% for patients in whom auto-HCT had failed and in | | | following first-line treatment with rituximab plus cyclopho- | patients who were ineligible for auto-HCT, respectively | | | sphamide, doxorubicin, vincristine, and prednisone [1,2] . | [13] . Brentuximab vedotin (BV) is an anti-CD30 antibody– | | | About half may achieve durable remission with salvage | drug conjugate approved for treatment of classical Hodgkin | | | therapy followed by autologo

FAQs

What patient population was evaluated in this DLBCL analysis?

The analysis reports results for the relapsed/refractory diffuse large B-cell lymphoma cohort from CheckMate 436, with n=42 patients.

What efficacy outcomes were observed for nivolumab plus brentuximab vedotin?

With a median follow-up of 7.7 months, overall response rate was 28.6% and complete response occurred in 7.1% of patients. Median duration of response was 3.6 months.

What were the key safety findings?

All patients experienced an adverse event, most commonly diarrhea. Grade 3/4 and grade 5 AEs occurred in 57.1% and 9.5% of patients, respectively, and no new safety signals were identified.

Sep 29, 2026

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