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EPCORE NHL-1

Epcoritamab monotherapy in patients with relapsed or refractory follicular lymphoma (EPCORE NHL-1): a phase 2 cohort of a single-arm, multicentre study

Phase 1/2NCT03625037

Population
Relapsed or refractory CD20-positive follicular lymphoma (grade 1 to 3A) after at least two prior lines of therapy; 128 in the pivotal cohort and 86 in the cycle 1 optimisation cohort.
Design
Phase 2 follicular lymphoma cohorts of a multicohort, single-arm phase 1-2 trial at 88 sites in 15 countries: subcutaneous epcoritamab 48 mg in 28-day cycles (weekly in cycles 1-3, biweekly in cycles 4-9, then every 4 weeks) until progression or unacceptable toxicity, in follicular lymphoma (grade 1 to 3A) after at least two prior lines including an anti-CD20 antibody and an alkylating agent or lenalidomide. Pivotal cohort: 128 patients; primary endpoint independently reviewed overall response rate. Cycle 1 optimisation cohort: 86 patients; primary endpoints grade 2 or worse and any-grade cytokine release syndrome.
Arms
  • Epcoritamab (pivotal cohort) (experimental, n = 128): Subcutaneous epcoritamab 48 mg in 28-day cycles after step-up dosing
People
Linton KM
Show the numbers
Results reported for EPCORE NHL-1
EndpointAnalysisEpcoritamab (pivotal cohort)ControlEffect
ORRPivotal cohort, all enrolled patients who received at least one dose (128)primarymedian follow-up 17.4 monthsLinton 202482% (74.3–88.3%)—105 of 128 patients; independent review.
CR ratePivotal cohort, all enrolled patients who received at least one dose (128)primarymedian follow-up 17.4 monthsLinton 202462.5% (53.5–70.9%)—80 of 128 patients.
Results reported for EPCORE NHL-1
EndpointAnalysisEpcoritamab (pivotal cohort)ControlEffect
ORRPivotal cohort, all enrolled patients who received at least one dose (128)primarymedian follow-up 17.4 monthsLinton 202482% (74.3–88.3%)—105 of 128 patients; independent review.
CR ratePivotal cohort, all enrolled patients who received at least one dose (128)primarymedian follow-up 17.4 monthsLinton 202462.5% (53.5–70.9%)—80 of 128 patients.
Primary publication: Linton KM, Vitolo U, Jurczak W, Lugtenburg PJ, Gyan E, Sureda A, et al. Epcoritamab monotherapy in patients with relapsed or refractory follicular lymphoma (EPCORE NHL-1): a phase 2 cohort of a single-arm, multicentre study. Lancet Haematol. 2024;11(8):e593-e605. PubMedDOI

Appears in

Sources

  1. Linton KM, Vitolo U, Jurczak W, Lugtenburg PJ, Gyan E, Sureda A, et al. Epcoritamab monotherapy in patients with relapsed or refractory follicular lymphoma (EPCORE NHL-1): a phase 2 cohort of a single-arm, multicentre study. Lancet Haematol. 2024;11(8):e593-e605.

    PubMedDOI