Lilly Announces Positive Results for Emgality from CONQUER Study

Eli Lilly and Company has announced Emgality® (galcanezumab-gnlm) met the primary and all key secondary outcomes in CONQUER, a Phase 3 study evaluating the efficacy and safety of Emgality in the preventive treatment of chronic and episodic migraine in patients with documented previous failures on two to four different standard-of-care migraine preventive medication categories, due to inadequate efficacy or for safety/tolerability reasons.

The CONQUER study was designed and conducted based on findings from subgroup analyses of prior Phase 3 studies of Emgality, which suggested it may be an option for patients who self-reported failures on migraine preventive medications before study enrollment.

"Preventive treatment failure has been a common occurrence among patients with migraine," said Gudarz Davar, M.D., 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."

CONQUER was a Phase 3, double-blind, global study conducted in 12 countries. The study enrolled 462 patients with chronic (n=193, 41.7%) or episodic migraine (n=269, 58.2%) who had a history of documented treatment failures to two to four different standard-of-care migraine preventive medication categories. Treatment failures were defined as inadequate efficacy after at least two months of treatment at the maximum tolerated dose, or discontinuation of the medicine for safety/tolerability reasons. At baseline, patients had on average 13.2 monthly migraine headache days. Following a screening period and prospective baseline period, eligible patients were randomized 1:1 to Emgality 120 mg per month (with a 240 mg loading dose) or placebo for three months of double-blind treatment. Patients who completed the double-blind treatment phase could enter a three-month open-label treatment phase with Emgality. The results below were analyzed from the three-month, double-blind period of the study.

The study met its primary objective of demonstrating superiority of Emgality versus placebo in the overall mean change from baseline in the number of monthly migraine headache days across Months 1 through 3. In the study, treatment with Emgality reduced monthly migraine headache days by 4.1 days (p<0.0001) compared with 1.0 day with placebo in the total (chronic and episodic migraine) study population.

In addition, the study achieved statistical significance 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 (MSQ-RFR) domain. The MSQ-RFR domain measures the degree to which migraine limits a person's daily social and work-related activities, including: feeling more energetic; feeling less tired for work or daily activities; concentrating better on work/daily activities; able to get more done at work and home; less difficulty performing work/daily activities; less interference in leisure activities and less interference dealing with family and friends. The details of these key secondary outcomes will be presented at an upcoming scientific congress and published in a peer-reviewed journal.

The safety profile of Emgality observed in the CONQUER study was consistent with the safety profile observed in Phase 3 studies of patients with migraine and cluster headache treated with Emgality.

Review of the international treatment landscape indicates that, among all migraine preventive medication users, more than 40% have a history of previous preventive medication failure or of switching treatments; and inadequate treatment of migraine is associated with increased health care resource utilization. Migraine is associated with an increase in outpatient visits, and the direct costs associated with health care resource utilization are even greater among patients with a history of switching and discontinuing multiple migraine preventive treatments.

Emgality is a monoclonal antibody that selectively binds to calcitonin gene-related peptide (CGRP) and was approved by the FDA in September 2018 for the preventive treatment of migraine in adults and in June 2019 for the treatment of episodic cluster headache in adults. Emgality was also approved in Europe in November 2018 for the prophylaxis of migraine in adults who have at least four migraine days per month.

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