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EPCORE NHL-1

A Phase 1/2, Open-label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

Phase 1/2N = 157NCT03625037

Population
Adults with relapsed or refractory CD20-positive large B-cell lymphoma after at least two prior therapy lines; median age 64 years; primary refractory disease 61.1%; prior CAR T-cell exposure 38.9%.
Design
Dose-expansion cohort of a phase I/II study: adults with relapsed or refractory CD20-positive large B-cell lymphoma and at least two prior therapy lines (including anti-CD20 therapy) received subcutaneous epcoritamab in 28-day cycles until disease progression or unacceptable toxicity. 157 patients treated as of 31 January 2022. Primary end point: overall response rate by independent review committee. ClinicalTrials.gov lists 666 enrolled for the whole registered study.
Primary endpoint
ORR
Arms
  • Epcoritamab monotherapy (experimental, n = 157): Subcutaneous epcoritamab with weekly step-up doses in cycle 1, then weekly, every 2 weeks and every 4 weeks as the cycles progress, until progression or unacceptable toxicity
People
Thieblemont C, senior author Lugtenburg PJ
Show the numbers
Results reported for EPCORE NHL-1
EndpointAnalysisEpcoritamab monotherapyControlEffect
ORRTreated patients (157)Overall response rate by independent review committee (stated primary end point).primarymedian follow-up 10.7 monthsThieblemont 202363.1% (55.0–70.6%)—Complete response rate 38.9% (95% CI 31.2 to 46.9). Median duration of response 12.0 months (not reached among complete responders).
CR rateTreated patients (157)primarymedian follow-up 10.7 monthsThieblemont 202338.9% (31.2–46.9%)——
PFSTreated patients (157)long term-updatemedian follow-up 25.1 monthsThieblemont 202427.8% at 2 y—Estimated 24-month overall survival 44.6%. Overall response rate 63.1% and complete response rate 40.1% at this cut-off. An estimated 64.2% of complete responders remained in complete response at 24 months.
Results reported for EPCORE NHL-1
EndpointAnalysisEpcoritamab monotherapyControlEffect
ORRTreated patients (157)Overall response rate by independent review committee (stated primary end point).primarymedian follow-up 10.7 monthsThieblemont 202363.1% (55.0–70.6%)—Complete response rate 38.9% (95% CI 31.2 to 46.9). Median duration of response 12.0 months (not reached among complete responders).
CR rateTreated patients (157)primarymedian follow-up 10.7 monthsThieblemont 202338.9% (31.2–46.9%)——
PFSTreated patients (157)long term-updatemedian follow-up 25.1 monthsThieblemont 202427.8% at 2 y—Estimated 24-month overall survival 44.6%. Overall response rate 63.1% and complete response rate 40.1% at this cut-off. An estimated 64.2% of complete responders remained in complete response at 24 months.
Primary publication: Thieblemont C, Phillips T, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, et al. Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial. J Clin Oncol. 2023;41(12):2238-2247. PubMedDOI

Appears in

Sources

  1. Thieblemont C, Phillips T, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, et al. Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial. J Clin Oncol. 2023;41(12):2238-2247.

    PubMedDOI

  2. Thieblemont C, Karimi YH, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, et al. Epcoritamab in relapsed/refractory large B-cell lymphoma: 2-year follow-up from the pivotal EPCORE NHL-1 trial. Leukemia. 2024;38(12):2653-2662.

    PubMedDOI