FDA D.I.S.C.O. Burst Edition: FDA approval of Epkinly (epcoritamab-bysp) for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma

Regulatory approval: On May 19, 2023, the FDA granted accelerated approval to epcoritamab-bysp (Epkinly), a CD20xCD3 bispecific T-cell engager, for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma) and high-grade B-cell lymphoma after ≥2 prior lines of systemic therapy. Approval was supported by the single-arm EPCORE NHL-1 trial, which reported an overall response rate of 61% and complete responses in 38% of patients.

FDA accelerated approval (May 19, 2023)

The FDA granted accelerated approval to epcoritamab-bysp (Epkinly) on May 19, 2023 for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified (including DLBCL arising from indolent lymphoma) and high-grade B-cell lymphoma, after two or more lines of systemic therapy.

Epcoritamab-bysp is a bispecific CD20-directed CD3 T-cell engager.

Supporting evidence

Approval was based on EPCORE NHL-1, an open-label, multi-cohort, multicenter, single-arm trial in patients with relapsed or refractory B-cell lymphoma.

  • Efficacy population: 148 patients with relapsed or refractory DLBCL (NOS, including transformed from indolent lymphoma) and high-grade B-cell lymphoma after ≥2 prior systemic therapies, including ≥1 anti-CD20 monoclonal antibody–containing regimen.
  • Primary efficacy endpoint: overall response rate (ORR) by Lugano 2014 criteria per Independent Review Committee.
  • Results: ORR 61%; complete response 38%.
  • Among responders, median follow-up 9.8 months; estimated median duration of response 15.6 months.

Safety highlights (prescribing information)

Epkinly carries a Boxed Warning for serious or life-threatening cytokine release syndrome (CRS) and life-threatening or fatal immune effector cell-associated neurotoxicity syndrome (ICANS). Additional warnings/precautions include infections and cytopenias.

In 157 patients treated at the recommended dose: CRS 51%, ICANS 6%, serious infections 15%.

Source: FDA D.I.S.C.O. Burst Edition; prescribing information at Drugs@FDA.

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