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ABCL-370: Novel Analysis of 3-Year Results From the Pivotal EPCORE NHL-1 Study: Outcomes in Patients With Relapsed/Refractory Large B-Cell Lymphoma (R/R LBCL) and Complete Response (CR) at 2 Years With Epcoritamab Monotherapy
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ABCL-370: Novel Analysis of 3-Year Results From the Pivotal EPCORE NHL-1 Study: Outcomes in Patients With Relapsed/Refractory Large B-Cell Lymphoma (R/R LBCL) and Complete Response (CR) at 2 Years With Epcoritamab Monotherapy

Yasmin H. Karimi, Julie M. Vose, Michael Roost Clausen, David Cunningham, Umar Farooq, Tatyana Feldman, Hervé Ghesquieres, Wojciech Jurczak, Kim M. Linton, Tycel Phillips, …
Clinical lymphoma, myeloma and leukemia, Vol.25(Suppl 1), pp.S733-S734
09/2025
DOI: 10.1016/S2152-2650(25)02253-0

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Abstract

Epcoritamab is a subcutaneous CD3xCD20 bispecific antibody approved for treatment of patients with diffuse large B-cell lymphoma (DLBCL) or high-grade BCL after ≥2 lines of treatment (LOT). In the 3-year follow-up from NHL-1 (NCT03625037), epcoritamab led to median duration of complete response (mDOCR) of 36 months, median progression-free survival (mPFS) of 37 months, and not reached (NR) median overall survival (mOS) in patients in CR. We report long-term outcomes in patients from NHL-1 in CR 2 years after starting treatment. Patients with R/R CD20+ LBCL and ≥2 prior LOT received epcoritamab in 28-day cycles (C; 0.16-mg and 0.8-mg step-up doses in C1; 48-mg full dose thereafter; QW C1–3; Q2W C4–9; Q4W C≥10) until progressive disease (PD) or unacceptable toxicity. The primary endpoint was overall response rate (ORR). As of May 3, 2024, 41% (65/157) of patients had CR, of whom 49% (n = 32) remained in CR at 2 years. Among the 32 patients in CR at 2 years, median age was 63 years; 47% were male, and 66% were refractory to ≥2 consecutive prior LOT. Median follow-up for these patients was 37 months (range, 32–46). mDOCR, mPFS, and mOS were NR; ~96% of patients remained in CR at 3 years, and the longest ongoing CR was >43 months. The overall safety profile in patients in CR at 2 years was consistent with that of the intent-to-treat population. Median treatment duration was 35 months (range, 8–43); 81% (26/32) of patients remained on treatment at 2 years. 19% (5/26) of patients still on treatment at 2 years had ≥1 serious infection after 2 years, most commonly pneumonia (n = 4). Two patients had a fatal infection (COVID-19 pneumonia, pneumonia) after 2 years. At data cutoff, 19/32 (59%) patients with CR at 2 years remained on treatment. One patient discontinued due to PD, and 12 discontinued for reasons other than PD, most commonly adverse events (n = 6, including the 2 patients with fatal infections). This subgroup analysis of patients with R/R LBCL in CR at 2 years after starting epcoritamab highlights long-term disease remission, OS, and long-term disease control with epcoritamab in some patients. Long-term safety remained manageable. c 2025 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2025 ASCO Annual Meeting. All rights reserved.
 ABCL bispecific antibody complete response diffuse large B-cell lymphoma long-term follow-up lymphoma non-Hodgkin phase 2

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