Exposure-Response Analyses to Inform the Optimal Epcoritamab Monotherapy Dosing Regimen in Relapsed or Refractory
Mahipal Sinnollareddy1,2, Kinjal Sanghavi3, Leonid Gibiansky4
1Clinical Pharmacology, AbbVie Inc., North Chicago, IL, USA. mahipal.sinnollareddy@abbvie.com.
Clinical Pharmacokinetics
|August 1, 2026
Summary
Epcoritamab shows high efficacy in relapsed/refractory follicular lymphoma. A 3-step step-up dosing regimen is recommended to optimize treatment and reduce cytokine release syndrome.
Area of Science:
- Hematology
- Oncology
- Pharmacology
Background:
- Epcoritamab is approved for treating relapsed/refractory (R/R) lymphomas.
- Previous studies in R/R follicular lymphoma (FL) showed high response rates with epcoritamab using a 2-step step-up dosing (SUD) regimen.
Purpose of the Study:
- To evaluate exposure-response relationships for epcoritamab.
- To optimize the dosing regimen for improved efficacy and safety in R/R FL patients.
Main Methods:
- Population pharmacokinetic modeling and exposure-response analyses were conducted.
- A 3-step SUD regimen was investigated and compared to the 2-step SUD regimen.
- Incidence and severity of cytokine release syndrome (CRS) were assessed.
Main Results:
- Higher epcoritamab exposure correlated with improved efficacy, including objective response rate (ORR) and complete response (CR) rate.
- The 3-step SUD regimen, with prophylaxis, reduced CRS frequency and severity compared to the 2-step SUD regimen.
- Similar pharmacokinetics and B-cell depletion were observed between the 3-step and 2-step SUD regimens.
Conclusions:
- The 3-step step-up dosing regimen with a 48 mg full dose of epcoritamab is supported and confirmed for R/R FL.
- This optimized regimen offers a favorable balance of efficacy and safety, including reduced CRS.