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Clinical Trial
. 2025 Apr 10;145(15):1621-1631.
doi: 10.1182/blood.2024026830.

Epcoritamab plus GemOx in transplant-ineligible relapsed/refractory DLBCL: results from the EPCORE NHL-2 trial

Joshua D Brody  1 , Judit Jørgensen  2 , David Belada  3 , Régis Costello  4 , Marek Trněný  5 , Umberto Vitolo  6 , David John Lewis  7 , Yasmin H Karimi  8 , Anna Sureda  9 , Marc André  10 , Björn E Wahlin  11 , Pieternella J Lugtenburg  12 , Tony Jiang  13 , Kubra Karagoz  14 , Andrew J Steele  15 , Aqeel Abbas  16 , Liwei Wang  17 , Malene Risum  18 , Raul Cordoba  19
Affiliations
Clinical Trial

Epcoritamab plus GemOx in transplant-ineligible relapsed/refractory DLBCL: results from the EPCORE NHL-2 trial

Joshua D Brody et al. Blood. .

Abstract

Patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) have poor outcomes (complete response [CR] rates with standard salvage therapy gemcitabine plus oxaliplatin [GemOx], ∼30%; median overall survival [OS], 10 to 13 months). Patients with refractory disease fare worse (CR rate with salvage therapy, 7%; median OS, 6 months). Epcoritamab, a CD3×CD20 bispecific antibody approved for R/R DLBCL after ≥2 therapy lines, has shown promising safety and efficacy in various combinations. We report results from the phase 1b/2 EPCORE NHL-2 trial evaluating epcoritamab plus GemOx in autologous stem cell transplant (ASCT)-ineligible R/R DLBCL. Patients received 48 mg subcutaneous epcoritamab after 2 step-up doses until progression or unacceptable toxicity; GemOx was given once every 2 weeks for 8 doses. The primary end point was overall response rate (ORR). As of 15 December 2023, 103 patients were enrolled (median follow-up, 13.2 months; median age, 72 years). Patients had challenging-to-treat disease: ≥2 prior therapy lines, 62%; prior chimeric antigen receptor T-cell therapy, 28%; primary refractory disease, 52%; refractory to last therapy, 70%. ORR and CR rate were 85% and 61%, respectively. Median duration of CR and OS were 23.6 and 21.6 months, respectively. Common treatment-emergent adverse events were cytopenias and cytokine release syndrome (CRS). CRS events had predictable timing, were primarily low grade (52% overall, 1% grade 3), and resolved without leading to discontinuation. Epcoritamab plus GemOx yielded deep, durable responses and favorable long-term outcomes in ASCT-ineligible R/R DLBCL. This trial was registered at www.clinicaltrials.gov as #NCT04663347.

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Conflict of interest statement

Conflict-of-interest disclosure: J.D.B. reports advisory role for ADC Therapeutics, Epizyme, and Seagen; and research funding from Bristol Myers Squibb, Genentech, Gilead/Kite, and Merck. J.J. reports consultancy role for AbbVie, Gilead, Incyte, Orion, Roche, and Sobi. D.B. reports consultancy role for AbbVie, Bristol Myers Squibb, Genmab, Gilead, MorphoSys, Roche, Sobi, and Takeda; honoraria from AbbVie, Gilead, Janssen, MorphoSys, Roche, and Takeda; and travel accommodations/expenses from AbbVie, Recordati, and Roche. M.T. reports consultancy role for AbbVie, Amgen, Bristol Myers Squibb, Genmab, Gilead, Incyte, Janssen, MorphoSys, Novartis, Roche, Sobi, and Takeda; honoraria from AbbVie, Amgen, Bristol Myers Squibb, Gilead, Janssen, MorphoSys, Novartis, Roche, and Takeda; and travel accommodations/expenses from AbbVie, Bristol Myers Squibb, Gilead, Janssen, Roche, and Takeda. U.V. reports advisory role for AbbVie, Genmab, Gilead, Incyte, and Regeneron; and lecture fees from AbbVie, Gilead, Incyte, Janssen, Merck Sharp & Dohme, Regeneron, Roche, and Servier. D.J.L. reports advisory and consultancy roles for Janssen, Lilly, Roche, BeiGene, and Kite. Y.H.K. reports advisory or consultancy roles for AbbVie and ADC Therapeutics; travel expenses from Roche/Genentech; and research funding from AbbVie, AstraZeneca, Lilly/Loxo, Merck, Roche/Genentech, and Xencor. A.S. reports consultancy role for Takeda, Bristol Myers Squibb, Novartis, Janssen, Merck Sharp & Dohme, Amgen, GlaxoSmithKline (GSK), Sanofi, Kite, and Mundipharma; honoraria from Takeda, Bristol Myers Squibb, Novartis, Janssen, Merck Sharp & Dohme, Amgen, GSK, Sanofi, and Kite; membership on an entity’s board of directors or advisory role for Takeda, Bristol Myers Squibb, Novartis, Janssen, Amgen, Bluebird, Sanofi, and Kite; travel expenses from Takeda, Bristol Myers Squibb, and Roche; research funding from Takeda; and speaker’s role for Takeda, Bristol Myers Squibb, Novartis, Janssen, Merck Sharp & Dohme, Amgen, GSK, Sanofi, and Kite. B.E.W. reports consultancy role and research funding from Roche, and research funding from Gilead. P.J.L. reports advisory honoraria from Bristol Myers Squibb, Roche, Takeda, Genmab, AbbVie, Incyte, Regeneron, and Sandoz; and consultancy honoraria from Y-mAbs Therapeutics. T.J. reports current employment at AbbVie. K.K., A.J.S., A.A., L.W., and M.R. report current employment and stock ownership at Genmab. R. Cordoba reports consultancy role for AbbVie, Janssen, AstraZeneca, Kite, Bristol Myers Squibb, Genmab, Roche, Takeda, Kyowa Kirin, BeiGene, and Lilly; speaker’s role for AbbVie, Janssen, AstraZeneca, Kite, Bristol Myers Squibb, Roche, and Takeda; and research funding from Pfizer. The remaining authors declare no competing financial interests.

Figures

None
Graphical abstract
Figure 1.
Figure 1.
Kaplan-Meier curves of efficacy outcomes. Kaplan-Meier curves by IRC assessment for PFS (A), OS (B), DOR (C), and DOCR (D) in the overall population and by pLOT. PFS was defined as time from cycle 1 day 1 to first documented progression or death due to any cause. OS was defined as time from cycle 1 day 1 to death due to any cause. A sensitivity analysis for OS censored patients at the date of last disease assessment before death due to confirmed COVID-19. DOR was defined as time from first CR or PR to first documented progression or death due to any cause. DOCR was defined as time from first CR to first documented progression or death due to any cause.
Figure 2.
Figure 2.
Response rates by subgroup. ORRs (A) and CR rates (B) by IRC assessment in subgroups. IPI, International Prognostic Index.
See this image and copyright information in PMC

Comment in

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