Eli Lilly’s migraine prevention medicine galcanezumab-gnlm (Emgality) showed efficacy in patients with a history of failure on other regimens, according to findings from a phase 3 study.
 
More than 40% of patients who use migraine preventive medications have a history of previous treatment failures or switching treatments, according to Lilly.
 
Galcanezumab-gnlm, a calcitonin gene-related peptide antagonist, was approved by the FDA for the preventive treatment of migraine and for episodic cluster headaches in adults. Based on findings from subgroup analyses of previous phase 3 studies, the CONQUER study aimed to determine whether galcanezumab-gnlm may serve as an option for patients who self-reported failures on other therapies.
 
The study evaluated galcanezumab-gnlm in the preventive treatment of chronic and episodic migraine in 462 patients with documented previous failures on 2 to 4 different standard-of-care preventive medication categories. Treatment failures were defined as inadequate efficacy after at least 2 months of treatment at maximum tolerated dose or discontinuation of the medicine for safety/tolerability reasons.
 
At the start of the trial, patients had an average of 12.3 monthly migraine headache days. Eligible patients received either galcanezumab-gnlm 120 mg per month (with a 240 mg loading dose) or a placebo for 3 months.
 
Overall, galcanezumab-gnlm reduced monthly migraine days by 4.1 days compared with 1.0 day with a placebo in the total study population, according to the results. The study also demonstrated statistically significant achievements on all key secondary outcomes, including 50%, 75%, and 100% response rates and improvements in the Migraine-Specific Quality of Life Questionnaire Role Function-Restrictive domain.
 
Additionally, the safety profile of galcanezumab-gnlm observed in the study was consistent with previous phase 3 studies of patients with migraine and cluster headache.
 
“Preventive treatment failure has been a common occurrence among patients with migraine,” Gudarz Davar, MD, vice president of neurology development at Lilly Bio-Medicines, said in a statement. “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.”
 
Reference
 
Lilly Announces Positive Results for Emgality (galcanezumab-gnlm) from the CONQUER Study in Patients who Failed Previous Migraine Preventive Treatments [news release]. Eli Lilly. https://investor.lilly.com/news-releases/news-release-details/lilly-announces-positive-results-emgalityr-galcanezumab-gnlm. Accessed August 5, 2019.