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Epcoritamab with rituximab and lenalidomide as first-line treatment for follicular lymphoma (EPCORE NHL-2): an open-label, multicentre, phase 1/2 b trial
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Epcoritamab with rituximab and lenalidomide as first-line treatment for follicular lymphoma (EPCORE NHL-2): an open-label, multicentre, phase 1/2 b trial

The Lancet Haematology·August 28Open Access
HematologySafety signalFollicular LymphomaPhase 1b/2 Open-Label Single-Arm TrialAnti-CD20 Monoclonal AntibodyBispecific AntibodyImmunomodulatory AgentAdultEpkinlyRevlimidRituxanEpcoritamabLenalidomideRituximab

Summary

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What was studied

This phase 1b/2 trial (EPCORE NHL-2, Arm 6) evaluated epcoritamab (subcutaneous CD3×CD20 bispecific antibody) combined with rituximab and lenalidomide as first-line chemotherapy-free treatment in 41 adults with grade 1–3A CD20+ follicular lymphoma, with a median follow-up of 35.9 months.

Key findings

The investigator-assessed overall response rate was 95% (39/41 patients; 95% CI 84–99%) at ~3 years of follow-up. Grade 3–4 adverse events included neutropenia (49%), infections (29%), and COVID-19 (15%). Treatment-related deaths occurred in 3 patients (7%): septic shock, progressive multifocal leukoencephalopathy, and COVID-19.

Study limitations

Single-arm design with no comparator limits causal inference; small sample size (n=41) reduces precision of estimates; race data were missing in 29% of patients, limiting generalizability.

Clinical implications

Epcoritamab plus rituximab-lenalidomide achieved a 95% response rate as first-line therapy for follicular lymphoma, but the 7% rate of treatment-related deaths—including PML—signals meaningful toxicity that warrants careful patient selection and monitoring before broader adoption.

Caveats

  • Brand name 'Epkinly' is the US/EU approved brand for epcoritamab; verify local availability and approval status in first-line follicular lymphoma, as this indication may not yet be approved.
  • Complete response rate and progression-free survival data are not reported in the abstract; only overall response rate is available.
  • The trial is phase 1b/2, single-arm, so efficacy comparisons to standard of care cannot be made directly from this study.
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  • Treatment-related mortality of 7% (3/41) is notable; the small sample size means this estimate carries wide uncertainty.

Related Questions

Explore related topics

What are the complete response rates and PFS data for epcoritamab plus R2 in first-line follicular lymphoma?How does epcoritamab plus rituximab-lenalidomide compare to rituximab-lenalidomide alone in follicular lymphoma?What is the risk of progressive multifocal leukoencephalopathy with bispecific antibodies in lymphoma?

Publication Details

Year
2026
Journal
The Lancet Haematology
Sample Size
n=41
Source
View article
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