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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.
References
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