Abstract
C012 | NOVEL ANALYSIS OF RESULTS FROM THE PIVOTAL EPCORE NHL-1 STUDY: OUTCOMES IN PATIENTS WITH RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA AND COMPLETE RESPONSE AT 2-YEARS WITH EPCORITAMAB MONOTHERAPY
Haematologica (Roma), Vol.110(s1)
09/01/2025
Abstract
Background: Depth and duration of CR correlate with long-term outcomes in LBCL. Epcor is a subcutaneous CD3xCD20 bispecific antibody approved for the treatment (tx) of pts with DLBCL or high-grade BCL after ≥2 lines of tx (LOT). In the 3-y follow-up (FU) from NHL-1 (NCT03625037), epcor led to durable CRs, with a 36-mo median CR duration (mDOCR), 37-mo median PFS (mPFS), and not reached (NR) median OS (mOS) in pts with R/R LBCL who had CR. We report long-term outcomes in pts from NHL-1 who were in CR 2y after starting tx. Methods: Pts with R/R CD20+ LBCL and ≥2 prior LOT received epcor in 28-d cycles (C; 0.16- 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. Primary endpoint was ORR. Results: As of May 3, 2024 data cutoff (DCO), 41% (65/157) of pts had CR, of whom 49% (n=32) remained in CR at 2y. Among the 32 pts in CR at 2y, median age was 63y, 47% were male, and 66% were refractory to ≥2 consecutive prior LOT. At DCO, median FU for pts in CR at 2y was 37 mo (range 32−46). All but 1 had a response (CR or partial response) by the 2nd assessment at wk 12. mDOCR, mPFS, mOS were NR, and ~96% of pts remained in CR at 3y. At the DCO, the longest ongoing CR was >43mo. Overall epcor safety profile in pts in CR at 2y was consistent with that of the intention-to-treat population. Median tx duration was 35mo (range 8–43). 81% (26/32) of pts remained on tx at 2y. 19% (5/26) of pts still on tx at 2y had ≥1 serious infection after 2y, most commonly pneumonia (n=4). Two pts had a fatal infection (COVID-19 pneumonia, pneumonia) after 2y. At DCO, 19/32 (59%) pts with CR at 2y were still on tx. One pt discontinued (d/c) due to PD; 12 d/c for reasons other than PD, most commonly adverse events (n=6, including the 2 pts with fatal infections above). In 12 pts who d/c due to reasons other than PD, CR was maintained for a median of 14mo (range 2−28) after tx d/c. Conclusions: This subgroup analysis of pts with R/R LBCL in CR at 2y after starting epcor highlights long-term disease remission, OS, and long-term disease control with epcor in some pts with 3L+ R/R LBCL. Long-term safety remained manageable. ©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.
Details
- Title: Subtitle
- C012 | NOVEL ANALYSIS OF RESULTS FROM THE PIVOTAL EPCORE NHL-1 STUDY: OUTCOMES IN PATIENTS WITH RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA AND COMPLETE RESPONSE AT 2-YEARS WITH EPCORITAMAB MONOTHERAPY
- Creators
- P.L. Zinzani - IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'OrsolaY. H. Karimi - University of MichiganJ.M. VoseM. Roost Clausen - Vejle HospitalD. Cunningham - Royal Marsden NHS Foundation TrustU. Farooq - University of IowaT. Feldman - Hackensack Meridian HealthH. Ghesquieres - Hospices Civils de LyonW. Jurczak - The Maria Sklodowska-Curie National Research Institute of OncologyK.M. Linton - University of ManchesterT. Phillips - U-M Rogel Cancer CenterW.S. Kim - Samsung Medical CenterP. Jafarinasabian - AbbVieM. GeybelsD. SoongB. D. MånssonC. W. EskelundM. AtiyaM. Hutchings - University of CopenhagenC. Thieblemont - Assistance Publique – Hôpitaux de ParisC.Y. Cheah - Sir Charles Gairdner Hospital
- Resource Type
- Abstract
- Publication Details
- Haematologica (Roma), Vol.110(s1)
- ISSN
- 0390-6078
- eISSN
- 1592-8721
- Publisher
- Ferrata Storti Foundation
- Language
- English
- Date published
- 09/01/2025
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9985014800402771
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