Lilly Announces Positive Results for Emgality™ (galcanezumab) from the CONQUER Study in Patients who Failed Previous Migraine Preventive Treatments

Failure to respond to migraine preventive treatments is a common occurrence;
internationally it is estimated that more than 40% of patients who use migraine preventive medications have a history of failure or switching treatments¹

TORONTO, Aug. 8, 2019 /CNW/ - Eli Lilly and Company (NYSE: LLY) recently announced that Emgality^™ (galcanezumab) 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.²

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.³

On July 30, 2019, Health Canada issued a Notice of Compliance (NOC) for Emgality for the prevention of migraine in adults who have at least 4 migraine days per month. Emgality is a monoclonal antibody that selectively binds to calcitonin gene-related peptide (CGRP).

"Every day in the clinic I meet people who suffer with migraines that impact their quality of life. Migraine is a neurological disease that can be disabling. Thanks to the persistent research, and the results seen in the CONQUER study, we are making progress," says Dr. Elizabeth Leroux, Headache Neurologist in Montreal and President of the Canadian Headache Society. "In Canada, CGRPs are a new class of medications approved for the prevention of migraine. Results of CONQUER will help us identify the patients that can benefit most from treatment with these."

"Preventive treatment failure among patients with migraine has been a common occurrence," said Doron Sagman, M.D., Senior Medical Director, Eli Lilly Canada Inc. (Lilly Canada). "We are pleased that the CONQUER study demonstrated a significant benefit for patients with chronic and episodic migraine who face such high 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.² 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.² At baseline, patients had on average 13.2 monthly migraine headache days.² 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.² 

Patients who completed the double-blind treatment phase could enter a three-month open-label treatment phase with Emgality.² The results below were analyzed from the three-month, double-blind period of the study.²

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 3.² In the study, treatment with Emgality reduced monthly migraine headache days by 4.1 days (p<0.0001) compared with 1.0 days with placebo in the total (chronic and episodic migraine) study population.²

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.² 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.⁴ 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.^2,5

For full prescribing information, including Patient Information, please refer to the Canadian Product Monograph for Emgality, available at www.lilly.ca.

In the U.S., the FDA approved Emgality in September 2018 for the preventive treatment of migraine in adults, and in June 2019 for the treatment of episodic cluster headache in adults.  In Europe Emgality was approved in November 2018 for the prophylaxis of migraine in adults who have at least four migraine days per month.

About Lilly Canada
Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people's needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.

Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto which eventually produced the world's first commercially-available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca.

References:
^1	Pike J, Mutebi A, Shah N, Jackson J, Cotton S, Desai PR, Sapra S. Factors associated with a history of failure and switching migraine prophylaxis treatment: an analysis of clinical practice data from the United States, Germany, France, and Japan. Value Health. 2016;19(3):A68.
^2	Data on file. July 2019.
^3	Zhang Q, Ruff D, Pearlman E, Govindan S, Aurora K. Efficacy of Galcanezumab in Patients Who Failed to Respond to Preventives Previously: Results from EVOLVE-1, EVOLVE-2 and REGAIN Studies. Neurology. 2018;90(Suppl 15):S20.004.
^4	Bagley CL, Rendas-Baum R, Maglinte GA, et al. Validating Migraine-Specific Quality of Life Questionnaire v2.1 in episodic and chronic migraine. Headache. 2012;52:3.
^5	Emgality [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC.
^6	Messali A, Sanderson JC, Blumenfeld AM, Goadsby PJ, Buse DC, Varon SF, Stokes M, Lipton RB. Direct and indirect costs of chronic and episodic migraine in the United States: a web-based survey. Headache. 2016;56(2):306-322.
^7	Shah AM, Bendtsen L, Zeeberg P, Jensen RH. Reduction of medication costs after detoxification for medication-overuse headache. Headache. 2013;53(4):665-672.
^8	Bonafede M, Cappell K, Sapra S, Shah N, Desai P, Tepper S. Direct costs associated with migraine in the US. Neurology. 2017;88(Suppl 16):P1.180.
^9	Ford J, Nyhuis A, Aurora S, Foster SA, Schroeder K. Cycling through migraine preventive treatments: implications to all-cause total direct costs. Cephalalgia. 2017;37(Suppl 1):272- 273.
^10	Raval AD, Shah A. National trends in direct health care expenditures among US adults with migraine: 2004 to 2013. J Pain. 2017;18(1):96-107.

SOURCE Eli Lilly Canada

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