P010 | Patient-reported Outcomes in Patients With Relapsed/refractory Follicular Lymphoma Treated With Epcoritamab Within the Entire Study Cohort and in Patients With Symptoms at Baseline
Year: 2025
Type: article
Abstract: Background: Maintaining or enhancing health-related quality of life (HRQoL) is critical for patients with incurable relapsed/refractory (R/R) follicular lymphoma (FL) alongside improving clinical outcomes. Epcoritamab, a subcutaneous T-cell–engaging bispecific antibody, has shown significant activity in R/R FL patients, including those with high-risk characteristics. Aims: To evaluate patient-reported outcomes (PROs) from EPCORE NHL-1 (NCT03625037), focusing on the entire cohort and subgroups with symptoms reported in the Functional Assessment of Cancer Therapy–Lymphoma (FACT-Lym) instrument and with ≥3 symptoms at baseline (BL). Methods: EPCORE NHL-1 was an open-label, phase 1/2 study for patients with R/R 3L+ FL grade 1–3A treated with subcutaneous epcoritamab (Linton et al. Lancet Hematol. 2024;11:e593). Patients completed the FACT-Lym at BL; on day (D) 1 of cycle (C) 3, 5, 7, and 9; and at treatment end. Minimally important difference (MID) thresholds were based on published literature (Carter et al. Blood. 2008;112:2376). Percentages of patients with meaningful improvement, stability, and deterioration for FACT-Lym were calculated using the upper-bound MID threshold. FACT-Lym mean change from BL scores were assessed for patients with any symptoms at BL and those with ≥3 symptoms at BL to determine HRQoL trajectory. Symptoms identified included body pain, fever, night sweats, lack of energy, tiredness, and weight loss. Analyses were performed for participants completing PROs at BL and ≥1 post-BL timepoint. Results: Compliance rates for FACT-Lym were high (>75%) at most time points. Across assessment timepoints (C3D1, C5D1, C7D1, C9D1), most patients (≥80%) maintained or improved HRQoL, measured by FACT-Lym total score (range 80.0–83.8%; C3D1: 83.8%; C5D1: 80.6%; C7D1: 80.0%; and C9D1: 80.4%), trial outcome index (range 81.8–90.5%;C3D1: 90.5%; C5D1: 89.6%; C7D1: 81.8%; and C9D1: 82.4%), and Lymphoma Subscale (LymS; range 84.3–94.6%; C3D1: 94.6%; C5D1: 88.1%; C7D1: 90.9%; and C9D1: 84.3%). Patients with symptoms at BL showed numeric HRQoL improvements, measured by LymS. For patients with ≥3 symptoms at BL, HRQoL improvements exceeded the MID threshold at C7D1 and C9D1. Conclusions: In EPCORE NHL-1, most R/R FL patients reported HRQoL maintenance or improvements on epcoritamab therapy. Epcoritamab showed meaningful HRQoL improvements for patients with high symptomatic burden at BL.
Authors: P.C. Johnson R. Tavarozzi*, A.C. Dueck, P. Ghione, A. Major, A. Wang, A. Alshreef, I. Nsiah, J. Yu, Z. Ding, A. Mutebi, P. Patah, E. Favaro, W. Jurczak
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7093122131
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