PMID- 38151388 OWN - NLM STAT- MEDLINE DCOM- 20240301 LR - 20240410 IS - 2152-2669 (Electronic) IS - 2152-2669 (Linking) VI - 24 IP - 3 DP - 2024 Mar TI - Improvements in Patient-Reported Outcomes in Relapsed or Refractory Large B-Cell Lymphoma Patients Treated With Epcoritamab. PG - e78-e87.e2 LID - S2152-2650(23)02183-3 [pii] LID - 10.1016/j.clml.2023.11.005 [doi] AB - BACKGROUND: Patient-reported outcomes were evaluated in EPCORE NHL-1 in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) treated with epcoritamab monotherapy (NCT03625037). MATERIALS AND METHODS: Adults with R/R CD20(+) LBCL and >/=2 prior systemic antilymphoma therapies, including anti-CD20, completed the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) and EQ-5D-3L. A subgroup of patients provided additional feedback in one-on-one qualitative interviews. FACT-Lym and EQ-5D-3L score changes from baseline (CFB) to cycle 9 or end of treatment were interpreted using published minimally important differences (MID). RESULTS: In total, 157 patients (88.5% with diffuse LBCL) were treated (median age, 64 years). In total, 70.7% had >/=3 prior treatments, 61.1% had primary refractory disease, and 82.8% were refractory to last systemic therapy. FACT-Lym scores exceeded MID thresholds: mean (SD) CFB were 4.4 (15.2), MID 3.0 to 7.0 (FACT-General); 5.9 (7.6), MID 2.9 to 5.4 (FACT-Lymphoma subscale); 8.4 (15.2), MID 5.5 to 11.0 (FACT-Trial Outcome Index); 10.3 (20.2), MID 6.5 to 11.2 (FACT-Lym total score). EQ-5D-3L index scores, 0.09 (0.20), MID 0.08, and EQ-VAS scores, 16.6 (22.8), MID 7.0, improved. In 20 qualitative interviews, 88.2% reported symptom improvements; 80.0% were "very satisfied" or "satisfied" with epcoritamab. CONCLUSIONS: R/R LBCL patients reported consistent, clinically meaningful improvements in symptoms and HRQoL and satisfaction with epcoritamab. CI - Copyright (c) 2023 The Authors. Published by Elsevier Inc. All rights reserved. FAU - Phillips, Tycel AU - Phillips T AD - University of Michigan Comprehensive Cancer Center, Ann Arbor, MI. Electronic address: tphillips@coh.org. FAU - Lugtenburg, Pieternella AU - Lugtenburg P AD - On behalf of the Lunenburg Lymphoma Phase I/II Consortium-HOVON/LLPC, Erasmus MC Cancer Institute, University Medical Center, Rotterdam, The Netherlands. FAU - Kalsekar, Anupama AU - Kalsekar A AD - Genmab, Plainsboro, NJ. FAU - Mutebi, Alex AU - Mutebi A AD - Genmab, Plainsboro, NJ. FAU - Wang, Anthony AU - Wang A AD - AbbVie, North Chicago, IL. FAU - Blaedel, Julie AU - Blaedel J AD - Genmab, Plainsboro, NJ. FAU - Kosa, Katherine AU - Kosa K AD - RTI Health Solutions, Ann Arbor, MI. FAU - Martin, Susan AU - Martin S AD - RTI Health Solutions, Ann Arbor, MI. FAU - Sacchi, Mariana AU - Sacchi M AD - Genmab, Plainsboro, NJ. FAU - Kilavuz, Nurgul AU - Kilavuz N AD - Genmab, Plainsboro, NJ. FAU - Thieblemont, Catherine AU - Thieblemont C AD - Assistance Publique & Hopitaux de Paris (APHP), Hopital Saint-Louis, Hemato-Oncologie, Universite de Paris, Paris, France. LA - eng SI - ClinicalTrials.gov/NCT03625037 PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20231127 PL - United States TA - Clin Lymphoma Myeloma Leuk JT - Clinical lymphoma, myeloma & leukemia JID - 101525386 RN - 0 (Antineoplastic Agents) SB - IM MH - Adult MH - Humans MH - Middle Aged MH - *Antineoplastic Agents MH - Quality of Life MH - *Lymphoma, B-Cell MH - *Lymphoma MH - Patient Reported Outcome Measures OTO - NOTNLM OT - Bispecific antibodies OT - EQ-5D-3L OT - FACT-Lym OT - Health-related quality of life OT - Qualitative data COIS- Disclosure Tycel Phillips: Seattle Genetics, Pharmacyclics, Incyte, Genentech, Bayer, Gilead Sciences, Curis, Kite/Gilead, Celgene, Genmab, TG Therapeutics, ADC Therapeutics: Consulting or Advisory Role; Seattle Genetics, Lymphoma & Myeloma Connect: Honoraria; AbbVie, Pharmacyclics/Janssen, Bayer: Research Funding; The Leukemia & Lymphoma Society: Scholar in Clinical Research; Pieternella Lugtenburg: Takeda, Servier: Research Grants; Celgene, Roche, Takeda, Genmab, AbbVie, Incyte, Regeneron: Advisory Honoraria. Y-mAbs Therapeutics: Consultancy Honoraria; Lilly: Speakers Bureau; Anupama Kalsekar: Employee of Genmab; Alex Mutebi: Employee of Genmab; Anthony Wang: Employee of AbbVie; Julie Blaedel: Employee of Genmab; Katherine Kosa: Employee of RTI Health Solutions who received funding from Genmab for the design, conduct, and analysis of the qualitative interviews; Susan Martin: Employee of RTI Health Solutions who received funding from Genmab for the design, conduct, and analysis of the qualitative interviews; Mariana Sacchi: Employee of Genmab; Nurgul Kilavuz: Employee of Genmab; Catherine Thieblemont: BMS/Celgene, Hospira, Roche: Research Funding; AbbVie, Amgen, BMS/Celgene, Cellectis, Gilead Sciences, Kite, Novartis, Roche: Consultancy; AbbVie, Amgen, Bayer, Cellectis, Gilead Sciences, Incyte, Janssen, Kite, Novartis, Takeda: Honoraria; AbbVie, Amgen, BMS/Celgene, Cellectis, Gilead Sciences, Incyte, Janssen, Kite, Novartis, Roche, Takeda: Membership on an Entity's Board of Directors or Advisory Committees; AbbVie, Amgen, BMS/Celgene, Cellectis, Gilead Sciences, Kite, Novartis, Roche: Travel, Accommodations, Expenses. EDAT- 2023/12/28 00:42 MHDA- 2024/03/01 06:44 CRDT- 2023/12/27 21:58 PHST- 2023/10/13 00:00 [received] PHST- 2023/11/21 00:00 [accepted] PHST- 2024/03/01 06:44 [medline] PHST- 2023/12/28 00:42 [pubmed] PHST- 2023/12/27 21:58 [entrez] AID - S2152-2650(23)02183-3 [pii] AID - 10.1016/j.clml.2023.11.005 [doi] PST - ppublish SO - Clin Lymphoma Myeloma Leuk. 2024 Mar;24(3):e78-e87.e2. doi: 10.1016/j.clml.2023.11.005. Epub 2023 Nov 27.