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Subcutaneous (SC) epcoritamab induces complete responses across R/R B-cell NHL subtypes: Updated dose-escalation data
Hutchings, M. Mous, R. Clausen, M. R. Johnson, P. Linton, Kim M Chamuleau, M. E. D. Lewis, D. J. Balari, A. S. Cunningham, D. Oliveri, R. S.
Hutchings, M.
Mous, R.
Clausen, M. R.
Johnson, P.
Linton, Kim M
Chamuleau, M. E. D.
Lewis, D. J.
Balari, A. S.
Cunningham, D.
Oliveri, R. S.
Citations
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Abstract
Background: Epcoritamab is a CD3CD20 bispecific antibody with a favorable safety
profile and encouraging preliminary antitumor activity in both aggressive and indolent
B-NHL in a phase I/II trial (NCT03625037). Updated dose-escalation data are reported
here.
Methods: Adults with R/R CD20+ B-NHL receive a SC 1 mL injection of flat-dose
epcoritamab in 28-day cycles (q1w: cycles 1-2; q2w: cycles 3-6; q4w thereafter) until
disease progression or unacceptable toxicity. Objectives include safety and antitumor
activity.
Results: As of 6 July 2020, 67 patients (pts) were enrolled (DLBCL, 67%; FL, 18%; MCL,
6%). Pts were heavily pretreated, with a median (range) of 3.0 (1-6) prior lines of
therapy for DLBCL and 4.5 (1-18) for FL. A total of 6 pts received prior CAR-T therapy.
At median follow-up of 8.3 months, treatment is ongoing in 25 pts (37%). Epcoritamab was generally well tolerated, with no discontinuations due to treatment-emergent adverse events (TEAEs). The most common TEAEs were pyrexia (70%), local
injection-site reactions (48%), and fatigue (45%). Observed TEAEs of special interest
were cytokine release syndrome (CRS; all events were Gr 1/2 [58%], no Gr 3/4) and
limited neurotoxicities (Gr 1, 3%; Gr 3, 3%; all transient). There were no DLTs, febrile
neutropenia events, or deaths due to TEAEs.
In pts with DLBCL treated with epcoritamab 12 mg (n¼18), ORR was 66.7% (6
CR). For pts who received higher doses (48 mg [RP2D], n¼4; 60 mg, n¼3) ORR was
100% (2 CR, 5 PR). All 4 DLBCL pts with prior CAR-T therapy achieved a response (2
CR, 2 PR).
In FL (epcoritamab 0.76 mg, n¼8), ORR was 100% (2 CR). Responses (1 CR,1 PR)
were observed in 2/4 pts with blastoid variant MCL.
Conclusions: Epcoritamab demonstrates a consistent, favorable safety profile, with no
Gr 3 CRS events and limited neurotoxicity, in support of future outpatient administration. Emerging data are encouraging, including CR in heavily y pretreated pts with
DLBCL, FL, and MCL.
Description
Date
2021
Publisher
Collections
Keywords
Type
Meetings and Proceedings
Citation
Hutchings M, Mous R, Clausen MR, Johnson P, Linton KM, Chamuleau MED, et al. O17-1 Subcutaneous (SC) epcoritamab induces complete responses across R/R B-cell NHL subtypes: Updated dose-escalation data. Annals of Oncology. 2021 Jul;32:S292.