Exposure-Response Analyses to Inform the Optimal Epcoritamab Monotherapy Dosing Regimen in Relapsed or Refractory Follicular Lymphoma.

What was studied

This analysis studied how drug exposure relates to results with epcoritamab. Epcoritamab is approved for several relapsed or refractory lymphomas. This paper looked at relapsed or refractory follicular lymphoma (FL). Data came from the EPCORE NHL-1 and NHL-3 studies. Earlier results showed high response rates with a 2-step step-up dosing (SUD) regimen. The authors updated a drug-level model to support the dosing plan. They evaluated full doses of 0.76-48 mg.

What they found

Higher exposure went with better efficacy. This covered response rate, complete response rate, progression-free survival and overall survival. Response rates may level off at 48 mg exposures. Initial response came in 96.2 of responders during weekly dosing. Most kept or improved response during Q2W and Q4W dosing. No meaningful trends linked exposure with side effects. This included cytokine release syndrome (CRS). A 3-step SUD regimen lowered CRS frequency and severity. Its doses were 0.16/0.8/3/48 mg. The comparison was with the 2-step regimen. It used hydration and dexamethasone in Cycle 1. Drug levels and B-cell depletion were similar. IL-6 stayed low with the 3-step regimen but not the 2-step one.

What it means for patients

The authors say the analyses support the 3-step regimen. It uses a 48 mg full dose. Dosing is weekly, then every 2 weeks, then every 4 weeks. They say this fits patients with relapsed or refractory FL.

Why it is not certain yet

The response plateau at 48 mg is only possible. These exposure links do not prove the dose caused the results. The abstract gives no numbers for the CRS drop. The earlier studies were phase 1/2 trials. The EPCORE NHL-3 group had only 21 patients.

Source

Exposure-Response Analyses to Inform the Optimal Epcoritamab Monotherapy Dosing Regimen in Relapsed or Refractory Follicular Lymphoma.

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