Exposure-response of different dosing schedules of naratuximab emtansine in combination with rituximab in Non Hodgkin’s lymphoma

Presented at PAGE 2022 meeting

Axel Facius², Marie-Claude Roubaudi-Fraschini¹, Antoine Attinger¹, Sandrine Micallef¹, Sandeepreddy Bommineni¹, Mariola Dymkowska¹, Gezim Lahu², Elisabeth Rouits¹

¹Debiopharm International SA, Lausanne, Switzerland
²ThinkQ2, Baar, Switzerland

Introduction

Naratuximab emtansine (nara) is an antibody-drug conjugate (ADC) comprised of a humanized anti-CD37 monoclonal antibody conjugated to the cytotoxic compound maytansinoid DM1. A phase 2 study (NCT02564744) evaluated the efficacy and safety of nara in combination with rituximab in NHL patients¹. Nara was administered as 3-week cycles at the dose of 0.7 mg/m2 every 3 weeks (Q3W) or at 0.4/0.2/0.2 mg/m2 weekly (QW) together with rituximab 375 mg/m2 once every 3 weeks. PK disposition of nara in combination with rituximab was evaluated in 98 patients. Additionally, PK/PD and exposure-response (E-R) were explored in DLBCL patients (n=29 and n=76, respectively) for the two dosing schedules.