Abstract Details

Title Immunogenicity Assessment from Phase 3 Galcanezumab Trials in Patients with Episodic or Chronic Migraine

Topic Headache

Presentation(s) P1 - Poster Session 1 (5:30 PM-6:30 PM)

Poster/Presentation
Number 13-017

Objective

To evaluate the immunogenicity profile of galcanezumab, a humanized IgG4 monoclonal antibody that selectively binds calcitonin gene-related peptide (CGRP) and inhibits its activity, in patients with episodic or chronic migraine.

Background Migraine is a neurological disorder with high disease burden and unmet clinical need.

Design/Methods Phase 3 galcanezumab migraine program consisted of 4 studies: 6-month double-blind (DB), placebo (PBO)-controlled EVOLVE-1 and EVOLVE-2 studies in episodic migraine, the 3-month DB/PC REGAIN study in chronic migraine, and the 12-month open label (OL) study CGAJ in chronic and episodic migraine. Immunogenicity was analyzed using data from baseline, DB phases and OL (CGAJ only) phases of the studies. Analyses assessed incidence of antidrug antibodies (ADA) at baseline, treatment-emergent ADA (TE ADA), neutralizing ADA, and TE ADA kinetics. Effect of ADA titer on pharmacokinetics and pharmacodynamics was assessed from concentration measurements of serum galcanezumab and plasma CGRP, respectively. The relationship between ADA status and efficacy was explored using average change in monthly migraine headache days. Safety analyses assessed the relationship between TE ADA and hypersensitivity events or adverse events (AEs) related to injection sites.

Results The percentage of patients with ADA at baseline ranged from 6.2%-11.2% (galcanezumab group) and 5.92%-8.35% (PBO group). The incidence of TE ADA across studies ranged from 2.6%-12.4% (galcanezumab group) and 0.5%-1.7% (PBO group). The majority of TE ADA in galcanezumab-treated patients were detected approximately 3-6 months after the first dose. Overall, the observed ADA titer in patients did not impact galcanezumab concentrations, CGRP concentrations, or the efficacy profile of galcanezumab. There was no evidence that hypersensitivity events and AEs related to injection sites were TE ADA mediated.

Conclusions Immunogenicity did not impact galcanezumab concentrations, CGRP concentrations, or the efficacy profile of galcanezumab.

Authors/Disclosures
James Martinez PRESENTER	No disclosure on file
Nada A. Hindiyeh, MD (Stanford University Medical Center)	Dr. Hindiyeh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Hindiyeh has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Hindiyeh has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alder/Lundbeck. Dr. Hindiyeh has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Dr. Hindiyeh has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Impel. Dr. Hindiyeh has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck .
	No disclosure on file
Kavita Kalidas, MD	No disclosure on file
	No disclosure on file
William Kielbasa	No disclosure on file
	No disclosure on file
Eric Pearlman, MD	Dr. Pearlman has received personal compensation for serving as an employee of Eli Lilly and Co. Dr. Pearlman has received stock or an ownership interest from Eli Lilly and Co.
	No disclosure on file

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