IRC recommends to focus on one dosage arm to complete the PARADIGME phase IIb trial

On August 6, 2020, after a planned interim analysis of the PARADIGME phase IIb trial, the Independent Review Committee (IRC) recommended to focus on one dosage arm to complete the study.¹

PARADIGME is the second part (part B) of the LYMRIT-37-01 phase I/IIa trial (NCT01796171) which showed promising results in patients with relapsed indolent non-Hodgkin lymphoma.² Results from the LYMRIT-37-01 phase I/IIa trial led to a

• positive opinion from the European Medicines Agency (EMA) for an orphan drug designation application for the treatment of marginal zone lymphoma (MZL)
• fast track designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed or refractory (R/R) follicular lymphoma (FL) after ≥ 2 prior systemic therapies, and for the treatment of adult patients with R/R MZL who have received ≥ 2 prior systemic therapies

The aim of the PARADIGME trial was to compare two different dosing regimens of ¹⁷⁷Lu-lilotomab satetraxetan, as a single administration, in patients with third-line relapsed/anti-CD-20-refractory FL who had received two or more prior therapies. The dosing regimens were as follows¹:

• 15 MBq/kg ¹⁷⁷Lu-lilotomab satetraxetan after 40 mg lilotomab pre-dosing (40/15 arm)
• 20 MBq/kg ¹⁷⁷Lu-lilotomab satetraxetan after 100 mg/m² lilotomab pre-dosing (100/20 arm)

The interim analysis confirmed that ¹⁷⁷Lu-lilotomab satetraxetan was active and well-tolerated in both arms and supported the selection of the 40/15 dosage arm which demonstrated consistency across all patient sub-groups. The 100/20 arm will be discontinued.¹

Three-month top-line data from PARADIGME are expected in the second half of 2021.