IBCL-460 Subcutaneouse pcoritamab with rituximab + lenalidomide (R(2)) in patients with relapsed or refractory (R/R) follicular lymphoma (FL): update from phase 1/2 trial
Falchi, L. ; Leppä, S. ; Wahlin, B. E. ; Nijland, M. ; Christensen, J. H. ; de Vos, S. ; Holte, H. ; ; Abbas, A. ; Wang, L. ... show 3 more
Falchi, L.
Leppä, S.
Wahlin, B. E.
Nijland, M.
Christensen, J. H.
de Vos, S.
Holte, H.
Abbas, A.
Wang, L.
Citations
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Abstract
Context: R/R FL is associated with a poor prognosis and remains
incurable; thus, better treatment options are needed. Epcoritamab
is a subcutaneously administered CD3xCD20 bispecifi c antibody
that has shown substantial antitumor activity in R/R FL. Objective:
Evaluate safety and effi cacy of epcoritamab with R2
in patients
with R/R FL in arm 2 of a phase 1/2 open-label trial (EPCORE
NHL-2; NCT04663347). Patients: Adults with R/R CD20+ FL
were included. As of December 1, 2021, 30 patients (median age,
68 y) had enrolled. Interventions: Patients received subcutaneous
epcoritamab (QW, cycle [C] 1–3; Q2W, C4–9; Q4W, C10 up to
2 y) + R2
for 12 cycles of 28 d. Step-up dosing and corticosteroid
prophylaxis were required. Results: Of the 30 patients (epcoritamab
24 mg, n=3; 48 mg, n=27), 21 (70%) had stage IV disease and 20
(67%) had FLIPI scores 3–5. Median (range) number of prior lines
of therapy was 1 (1–5), 30% had primary refractory disease, and
40% had disease progression within 24 mo after starting fi rst-line
treatment. At a median (range) follow-up of 5.1 mo (0.8–12.3),
25 patients (83%) remained on treatment; 5 patients discontinued
treatment due to progression (n=2), AEs (n=2), or consent
withdrawal (n=1). Common treatment-emergent AEs (TEAEs) of
any grade (G) included infections (57%), injection-site reactions
(50%), constipation (37%), fatigue (37%), and neutropenia (37%).
CRS events occurred in 15 patients (50%; G1–2 43%, G3 7%),
primarily in C1. All CRS events resolved; 3 patients were treated with
tocilizumab, and 1 patient discontinued treatment due to CRS. One
patient experienced G2 ICANS. No fatal TEAEs occurred. Overall
response rate for the 27 evaluable patients was 100%; 93% had a
complete metabolic response (CMR) and 7% had a partial metabolic
response by PET-CT. As of the data cut, the longest duration of
response was 7.0+ mo and ongoing. Conclusions: Subcutaneous
epcoritamab + R2
exhibits promising effi cacy, including a high CMR
rate, in patients with R/R FL. The safety profi le was consistent with
prior data. Updated data will be presented.
Description
Date
2022
Publisher
Collections
Keywords
Type
Meetings and Proceedings
Citation
Falchi L, Leppä S, Wahlin BE, Nijland M, Christensen JH, de Vos S, et al. IBCL-460 Subcutaneous Epcoritamab With Rituximab + Lenalidomide (R(2)) in Patients With Relapsed or Refractory (R/R) Follicular Lymphoma (FL): Update from Phase 1/2 Trial. Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S392. PubMed PMID: 36164115. Epub 2022/09/28. eng.