Background: Nipocalimab and efgartigimod are FcRn-targeting treatments for generalized myasthenia gravis (gMG) with differing molecular structures, binding affinities, and dosing. Currently, there are no trials directly comparing efficacy of nipocalimab vs efgartigimod and no data to inform switch strategies from efgartigimod to nipocalimab.
Objective: EPIC aims to evaluate efficacy of nipocalimab vs efgartigimod in participants initiating FcRn treatment for gMG and to evaluate efficacy and safety of nipocalimab in participants switching from efgartigimod to nipocalimab. EPIC is a phase 3b, randomized, open-label, interventional study in adults with gMG. FcRn-naïve participants (n=80) are randomized 1:1 to receive nipocalimab every 2 weeks for 12 weeks (Arm 1) or efgartigimod every week (10 mg/kg) for 4 weeks (Arm 2). Participants in Arm 2 and additional participants with ≥1 on-label efgartigimod cycle (minimum n=35) can enroll in the treatment switch phase of the study to be followed on nipocalimab for 12 weeks (Arm 3).
Results: This study addresses whether nipocalimab provides superior efficacy to efgartigimod in the latter part of efgartigimod cycles that cover most dosing patterns utilized in clinical practice. Key primary and secondary efficacy endpoints are change from baseline in total IgG, MG-ADL, and QMG scores between Arms 1 and 2 at the following time points: 1) averaged over Weeks 8–12, 2) at end of cycle based on clinical evaluation/end of treatment, and 3) at Week 8. Key endpoints for treatment switch are change in MG-ADL and safety in Arm 3.
Conclusions: EPIC is the first randomized trial comparing advanced treatments for patients with gMG and is designed to provide critical insights to inform clinical decisions when initiating or switching in the FcRn-targeting class.