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• W4380084002 abstract "Introduction: Patients with previously untreated (1L) diffuse large B-cell lymphoma (DLBCL) typically receive rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP); however, around 40% of these patients relapse. Complete response rates and long-term outcomes are worse for high-risk patients with International Prognostic Index (IPI) 3–5 or double-hit/triple-hit lymphoma, representing an underserved patient population requiring better curative options. Data from the pivotal study of single-agent epcoritamab, a T-cell–engaging bispecific antibody, demonstrated impressive efficacy and a manageable safety profile (Thieblemont et al., J Clin Oncol, 2022). Preliminary data for epcoritamab + R-CHOP in 1L DLBCL from the EPCORE™ NHL-2 phase 1/2 trial (NCT04663347; arm 1) showed encouraging efficacy. Here we present results for a larger cohort with longer follow-up. Methods: Patients with 1L CD20+ DLBCL and IPI ≥3 received subcutaneous epcoritamab (cycles 1–4, QW; cycles 5–6, Q3W) + R-CHOP for 6 cycles (21 days each) followed by epcoritamab monotherapy Q4W (28-day cycles) up to a total of 1 year. Results: As of October 31 2022, 47 patients (median age, 64 years) had received epcoritamab 48 mg + R-CHOP with a median follow-up of 11.5 months (range 0.8–15.5). All patients had IPI 3–5, 37 (79%) had stage IV disease, and 11 (44%) of 25 patients with FISH data available had double-hit/triple-hit DLBCL. Median time from diagnosis to first dose was 28 days (range 3–423). Median dose intensity for R-CHOP was ≥95%. The most common treatment-emergent AEs (TEAEs) of any grade (G) were neutropenia (64%), anemia (62%), CRS (60%), fatigue (40%), pyrexia (40%), injection-site reactions (38%), and nausea (38%). TEAEs led to epcoritamab discontinuation in 3 patients; 1 patient had a G5 TEAE (COVID-19, unrelated to treatment). CRS was predominantly low grade (57% G1–2, 2% G3) and occurred mostly after the first full dose (cycle 1, day 15); all cases resolved. One patient experienced G2 ICANS, which resolved in 4 days. All response-evaluable patients (100%) had a response, and 76% had a complete metabolic response (CMR; Table). Notably, response rates were similar for patients with double-hit/triple-hit DLBCL (CMR rate, 82% [9/11]). Median progression-free survival, overall survival, and duration of response were not reached. Responses were durable; at 9 months, an estimated 96% of patients with CMR remained in CMR. Updated data will be presented. Conclusions: Subcutaneous epcoritamab + R-CHOP induces high CMR rates with a manageable safety profile in patients with 1L high-risk DLBCL, including patients with double-hit/triple-hit lymphoma. These results support the ongoing phase 3 study of epcoritamab + R-CHOP in 1L patients (NCT05578976). Encore Abstract—previously submitted to ASCO 2023 The research was funded by: This study was funded by Genmab A/S and AbbVie. Keywords: aggressive B-cell non-Hodgkin lymphoma, immunotherapy Conflicts of interests pertinent to the abstract L. Falchi Consultant or advisory role: AbbVie, Genentech, Genmab, Roche, ADC Therapeutics, AstraZeneca, Genentech, Seagen Research funding: AbbVie, Genentech, Genmab, Roche M. R. Clausen Consultant or advisory role: AbbVie, Janssen, Gilead, AstraZeneca, Genmab Educational grants: AbbVie, Janssen, AstraZeneca, Genmab J. Brody Consultant or advisory role: ADC Therapeutics, Epizyme, Seagen Research funding: BMS, Genentech, Gilead/Kite, Merck K. M. Linton Consultant or advisory role: AbbVie, BeiGene, BMS, Celgene, Genmab, Kite/Gilead, Roche Research funding: AbbVie, Celgene: Speakers Bureau; AbbVie, ADC Therapeutics, AstraZeneca, BeiGene, BMS, Celgene, CellCentric, Genmab, Janssen, Kite/Gilead, MorphoSys, MSD, Nurix, Regeneron, Roche, Step Pharma, Viracta (Paid to Institution) Educational grants: Celgene Other remuneration: Genmab: Member of the Epcoritamab Global Council; AbbVie, Celgene: Speakers Bureau R. Cordoba Consultant or advisory role: AbbVie, Janssen, AstraZeneca, Kite, BMS, Genmab, Roche, Takeda, Kyowa Kirin, BeiGene, Lilly Research funding: Pfizer Other remuneration: AbbVie, Janssen, AstraZeneca, Kite, BMS, Roche, Takeda: Speakers Bureau J. Wu Employment or leadership position: AbbVie I. Bykhovski Employment or leadership position: Genmab L. Wang Employment or leadership position: Genmab A. Rana Employment or leadership position: Genmab D. Belada Research funding: Genmab" @default.
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• W4380084002 title "HIGH COMPLETE METABOLIC RESPONSE RATES WITH EPCORITAMAB + R‐CHOP IN PREVIOUSLY UNTREATED (1L) HIGH‐RISK DLBCL, INCLUDING DOUBLE‐HIT/TRIPLE‐HIT: EPCORE NHL‐2 UPDATE" @default.
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