Rapid Readout: Phase 1/2 Trial of Subcutaneous Epcoritamab With R-Squared in Patients with Relapsed or Refractory Follicular Lymphoma

Tycel Phillips, MD, discusses a phase 1/2 trial combining subcutaneous epcoritamab with rituximab and lenalidomide in patients with relapsed or refractory follicular lymphoma, as presented at the 63rd ASH Annual Meeting in 2021.

Tycel Phillips, MD, discusses data from the following study:

  • Subcutaneous Epcoritamab in Combination with R2 (Rituximab and Lenalidomide) in Patients with Relapsed or Refractory Follicular Lymphoma: Preliminary Results from a Phase 1/2 Trial. (ASH 2021, Dec 11-14. Poster 3535)
  • The objective of EPCORE NHL-2 arm 2 is to report results of epcoritamab in combination with R2 in patients with relapsed/refractory follicular lymphoma (FL).
  • R2 has immunomodulatory properties that may potentiate the activity of epcoritamab, suggesting that combining R2 with epcoritamab may be beneficial.
  • 29 adults with relapsed/refractory FL were enrolled to receive subcutaneous epcoritamab + standard R2 for 12 cycles of 28 days, followed by epcoritamab monotherapy, for a total of 2 years.
  • Safety and efficacy outcomes were assessed in the population:
    • Best overall response (OR) rate was assessed at 100%, with complete metabolic response (CMR) at 81% and partial metabolic response at 19%.
    • As of November 3, 2021, the updated data-cutoff date, OR rate was 100% and CMR was 92%.
    • The median number of cycles initiated was 7 for 24 mg: 3 for 48 mg and 3 overall.
    • No dose-limiting toxicities (DLTs), immune effector cell-associated neurotoxicity syndrome (ICANS), clinical tumor lysis syndrome (TLS) events, or fatal treatment-emergent adverse events (TEAEs) were reported.
    • 6 TEAEs, 3 of which were cytokine-release syndrome (CRS), led to epcoritamab dose delays.
    • All CRS events resolved with standard management, and patients who experienced CRS mostly experienced it after cycle 1, day 15.
  • Conclusions:
    • Preliminary data for subcutaneous epcoritamab in combination with R2 demonstrated a manageable safety profile with no DLTs, ICANS, or TLS events.
    • Response was seen in 100% of patients, with nearly all achieving early CMR and no relapses observed.
    • There were no cases of progressive disease.
    • These data support further studies of epcoritamab + R2 in relapsed/refractory FL; expansion cohort 2b will enroll up to approximately 80 additional patients.

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