Abstract
ABCL-191 Extended Follow-Up Beyond 2.5 Years Demonstrates Long-Term Efficacy in Complete Responders Following Epcoritamab Monotherapy in Relapsed or Refractory Large B-Cell Lymphoma (R/R LBCL)
Clinical lymphoma, myeloma and leukemia, Vol.24(Supplement 1), pp.S461-S462
09/2024
DOI: 10.1016/S2152-2650(24)01495-2
Abstract
Epcoritamab, a CD3xCD20 bispecific antibody, demonstrated high rates of complete response (CR) and minimal residual disease (MRD) negativity, durable responses, and manageable safety in patients with challenging-to-treat R/R LBCL in EPCORE® NHL-1 (pivotal phase 2; NCT03625037).
To show long-term follow-up results, including additional subgroup efficacy analyses, in patients with CR from the expansion cohort and results from the cycle 1 optimization part (C1 OPT).
Patients with R/R CD20+ LBCL and ≥2 prior treatment lines received subcutaneous epcoritamab (28-day cycles; per label) in an expansion cohort. The primary endpoint of expansion was overall response rate (ORR). C1 OPT enrolled a separate cohort of patients with diffuse LBCL (DLBCL) and assessed CRS incidence/severity; hydration and dexamethasone prophylaxis were highly recommended in C1, and hospitalization was not mandated.
The LBCL expansion cohort enrolled 157 patients (148 with DLBCL or high-grade B-cell lymphoma [HGBCL]). Baseline characteristics were previously reported. As of April 21, 2023 (median follow-up, 25.1 months), ORR/CR rates by independent review committee were 63%/40% (LBCL) and 61%/39% (DLBCL + HGBCL). Safety was consistent with previous reports. CRS was the most common AE (51% any grade [G]; 32% G1, 16% G2, 3% G3). As of October 16, 2023, 30-month estimates in patients with CR per investigator assessment (n=65; median follow-up, 31.3 months) were 54% remaining in CR, 55% remaining progression free, and 71% remaining alive. Of 49 MRD-evaluable patients with CR, 92% were MRD negative at any on-treatment time point. C1 OPT enrolled 60 patients (median follow-up, 1.7 months). Overall CRS incidence among CRS-evaluable patients (n=36) was 22%; events were low grade (14% G1, 8% G2) and mainly occurred following the first full dose. All CRS events resolved; none led to treatment discontinuation. G1 ICANS was reported in 1 patient.
Long-term results demonstrate that epcoritamab drives deep responses beyond 2.5 years. No new safety signals were reported. Simple measures of prophylactic dexamethasone and adequate hydration in C1 decreased rates and severity of CRS. These outcomes underscore the long-term benefit of epcoritamab monotherapy for the treatment of R/R LBCL.
This study was funded by Genmab A/S and AbbVie.
Details
- Title: Subtitle
- ABCL-191 Extended Follow-Up Beyond 2.5 Years Demonstrates Long-Term Efficacy in Complete Responders Following Epcoritamab Monotherapy in Relapsed or Refractory Large B-Cell Lymphoma (R/R LBCL)
- Creators
- Yasmin H. Karimi - U-M Rogel Cancer CenterCatherine Thieblemont - Assistance Publique – Hôpitaux de ParisHerve Ghesquieres - Hospices Civils de LyonChan Y. Cheah - University of Western AustraliaMichael Roost Clausen - Vejle SygehusDavid Cunningham - Royal Marsden NHS Foundation TrustWojciech Jurczak - The Maria Sklodowska-Curie National Research Institute of OncologyKim M. Linton - University of ManchesterMartin Hutchings - University of CopenhagenTycel Phillips - U-M Rogel Cancer CenterUmar Farooq - University of IowaWon Seog Kim - Samsung Medical CenterMinh H. Dinh - AbbVieJagannath Ghosh - GenmabRajash Pallai - GenmabMonica Wielgos-Bonvallet - GenmabChristian Eskelund - GenmabPieternella J. Lugtenburg - Erasmus MCJulie M. Vose - University of Nebraska Medical Center
- Resource Type
- Abstract
- Publication Details
- Clinical lymphoma, myeloma and leukemia, Vol.24(Supplement 1), pp.S461-S462
- Publisher
- Elsevier Inc
- DOI
- 10.1016/S2152-2650(24)01495-2
- ISSN
- 2152-2650
- Language
- English
- Date published
- 09/2024
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984699514102771
Metrics
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