ABCL-452 First-line treatment with subcutaneous epcoritamab + R-CHOP in patients with high-risk diffuse large B-cell lymphoma (DLBCL): phase 1/2 data update
Falchi, L. Offner, F. Belada, D. Brody, J. Linton, Kim M Karimi, Y. Cordoba, R. Snauwaert, S. Abbas, A. Wang, L.
Falchi, L.
Offner, F.
Belada, D.
Brody, J.
Linton, Kim M
Karimi, Y.
Cordoba, R.
Snauwaert, S.
Abbas, A.
Wang, L.
Citations
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Abstract
Context: Patients with newly diagnosed high-risk DLBCL
have suboptimal outcomes. Subcutaneous epcoritamab is a
CD3xCD20 bispecifi c antibody well suited for combination with
standard of care therapies. Objective: Evaluate safety and effi cacy
of epcoritamab + rituximab, cyclophosphamide, doxorubicin,
vincristine, and prednisone (R-CHOP) in previously untreated
patients with high-risk DLBCL in arm 1 of a phase 1/2, open label trial (EPCORE NHL-2; NCT04663347). Patients: Adults
with previously untreated CD20+
DLBCL and IPI 3 were
included. As of December 1, 2021, 33 patients (median age, 66
y) had enrolled. Interventions: Patients received subcutaneous
epcoritamab (QW, cycles 1–4; Q3W, cycles 5–6) + R-CHOP for 6
cycles (21 d) followed by epcoritamab monotherapy Q4W up to 1
y (in cycles of 28 d). Step-up dosing and corticosteroid prophylaxis
were required. Results: All 33 patients treated (epcoritamab 24
mg, n=4; 48 mg, n=29) had IPI 3, and 24% had double/triple hit DLBCL. Median follow-up was 3 mo (range, 0–9.7), median
number of total cycles initiated was 5 (1–13), and 94% of patients
(31/33) remained on treatment. Treatment-emergent AEs (TEAEs)
in 35% of patients were neutropenia (48%; febrile neutropenia in
9% of all patients), CRS (45%), infections (42%), anemia (39%),
and injection-site reactions (36%). No TEAEs led to epcoritamab
discontinuation. Most CRS events were low grade (42% grade [G]
1–2, 3% G3), occurred in cycle 1, and resolved after a median of 2
d (1–11); 4 patients received tocilizumab. G2 ICANS occurred in
1 patient. No fatal TEAEs occurred. In effi cacy-evaluable patients,
the overall response rate (ORR) was 96% (24/25); 68% (17/25) had
complete metabolic response (CMR) by PET-CT. In the 10 patients
who completed 6 cycles of R-CHOP by the cutoff date, ORR and
CMR rate were 100% and 90%, respectively; all patients remained
in response at data cutoff (longest duration of response, 7.1+ mo,
ongoing). Conclusions: Epcoritamab + R-CHOP had manageable
safety, mostly low-grade CRS that did not lead to treatment
discontinuation, and high response rates in patients with previously
untreated DLBCL. Updated data will be presented.
Description
Date
2022
Publisher
Collections
Keywords
Type
Meetings and Proceedings
Citation
Falchi L, Offner F, Belada D, Brody J, Linton KM, Karimi Y, et al. ABCL-452 First-Line Treatment With Subcutaneous Epcoritamab + R-CHOP in Patients With High-Risk Diffuse Large B-Cell Lymphoma (DLBCL): Phase 1/2 Data Update. Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S380. PubMed PMID: 36164092. Epub 2022/09/28. eng.