In the CONQUER trial (NCT03559257), treatment with galcanezumab (Emgality; Eli Lilly, Indianapolis, IN) was superior to placebo at preventing migraine in individuals with migraine refractory to other treatments. Treatment with galcanezumab reduced monthly migraine days from a mean of 13.2 days/month to 9.1 days/month Participants in this trial treated with placebo had a reduction of only 1.0 days per month (P < .0001).
Galcanezumab was also superior to placebo on key secondary outcomes including 50%, 75%, and 100% response rates and improvements in the Migraine-Specific Quality of Life Questionnaire Role Function-Restrictive (MSQ-RFR) domain.
"Preventive treatment failure has been a common occurrence among patients with migraine," said Gudarz Davar, MD, vice president, neurology development, Lilly Bio-Medicines. "The CONQUER study applied strict and rigorous criteria to identify and enroll patients with chronic and episodic migraine who had failed multiple migraine preventive treatments, with the goal of understanding whether Emgality may be an effective option for patients with such significant unmet need."
The CONQUER trial, enrolled 462 participants with chronic (n = 193, 41.7%) or episodic migraine (n = 269, 58.2%) who had inadequate efficacy with other treatments tried for at least 2 months at the maximum tolerated dose or discontinued a treatment because of safety/intolerability issues. Participants had a mean baseline frequency of 13.2 monthly migraine days and were randomly assigned to receive galcanezumab (120 mg/month) or placebo for 3 months.
Galcanezumab-gnlm is a monoclonal antibody that selectively binds to calcitonin gene-related peptide (CGRP) for the preventive treatment of migraine in adults and treatment of episodic cluster headache in adults.