Emgality ® (galcanezumab-gnlm) injection

100 mg/mL, 120 mg/mL

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Is EMGALITY® (galcanezumab-gnlm) effective in treatment-resistant migraine?

Emgality (galcanezumab) was superior to placebo in reducing monthly migraine headache days in patients with episodic or chronic migraine who had not benefited from previous migraine preventive treatments.

CONQUER Study Overview

CONQUER was a phase 3 randomized double-blind, placebo-controlled study that assessed galcanezumab efficacy and safety in adult patients with episodic migraine or chronic migraine who had not benefited from multiple previous migraine preventive treatments.1

CONQUER had a double-blind treatment duration of 3 months, with an optional 3-month open-label extension phase.1

Patients were randomized at the beginning of double-blind treatment in a 1:1 ratio to receive monthly subcutaneous injections of placebo, or galcanezumab 120 mg with a loading dose of 240 mg.1

Treatment resistance was defined as a documented previous failure of 2 to 4 migraine preventive medication categories in the past 10 years due to inadequate efficacy and/or safety/tolerability reasons. These medication categories included

  • propranolol or metoprolol

  • topiramate

  • valproate or divalproex

  • amitriptyline

  • flunarizine

  • candesartan

  • botulinum toxin A or B, or

  • medication locally approved for prevention of migraine.1

The primary endpoint was the overall mean change from baseline in number of monthly migraine headache days across months 1 to 3.1

Baseline Disease Characteristics

Baseline characteristics are provided in Table 1.

Table 1. Baseline Disease Characteristics: CONQUER1,2

 

PBO
N=230

GMB 120 mg
N=232

Migraine headache days per month, mean

13.0

13.4

Migraine headache days per month, episodic population, mean

9.2

9.5

Migraine headache days per month, chronic population, mean

18.1

19.2

Number of migraine preventive medication failures in the past 10 years, mean

3.3

3.3

Migraine Frequency

   Low episodic, %a

15.7

15.1

   High episodic, %b

41.7

44.0

   Chronic, %c

42.6

41.0

MSQ-RFR, mean

44.0

45.8

Abbreviations: GMB = galcanezumab; MSQ-RFR = Migraine-Specific Quality-of-Life Questionnaire Role Function-Restrictive; PBO = placebo.

a Low episodic: 4 to <8 migraine headache days/month and <15 headache days/month.

b High episodic: 8-14 migraine headache days/month.

c Chronic: ≥8 migraine headache days/month and ≥15 headache days/month.

Based on lifetime history, the prior migraine preventive medications which were most commonly used (by >20% of patients) were

  • topiramate (76.0%)

  • amitriptyline (56.1%)

  • propranolol (35.7%)

  • valproic acid (34.9%)

  • botulinum toxin A (22.9%), and

  • metoprolol (20.4%).3

Galcanezumab Significantly Reduced the Mean Monthly Migraine Headache Days During Double-Blind Treatment

Galcanezumab significantly reduced the mean monthly migraine headache days across months 1 to 3 in the total population and in each subpopulation (episodic migraine and chronic migraine): Table 2.1

Table 2. Change From Baseline in the Number of Monthly Migraine Headache Days During Double-Blind Treatment: CONQUER1

Overall Population

N

LS Mean Change from Baselinea

PBO

228

-1.02

GMB 120 mg

230

-4.14b

Episodic Migraine

PBO

132

-0.31

GMB 120 mg

137

-2.88b

Chronic Migraine

PBO

96

-2.21

GMB 120 mg

93

-5.91b

Abbreviations: GMB = galcanezumab; LS = least squares; PBO = placebo.

a Months 1 to 3.

b p<.0001 vs placebo.

Results at each month for the entire population are shown in: Figure 1. Results were consistent in the episodic and chronic migraine subpopulations.1

Compared with placebo, galcanezumab significantly reduced the mean monthly migraine headache days from months 1 to 3.1

All Key Secondary Endpoints Were Met With Galcanezumab 120 mg During Double-Blind Treatment

All key secondary endpoints were met for galcanezumab 120 mg in the total population (episodic migraine and chronic migraine combined). Galcanezumab was superior to placebo (p<.0001) in

  • 50%, ≥75%, and 100% response rates, and

  • improving restrictions on daily functioning.1

The onset of effect of galcanezumab 120 mg was rapid, occurring at week 1, and sustained over month 1.1

Safety Results During Double-Blind Treatment

Galcanezumab 120 mg was well tolerated with no significant differences in treatment-emergent adverse events between treatment groups.1

Treatment-emergent adverse events experienced by at least 2% of galcanezumab-treated patients are provided in Table 3.

Table 3. Treatment-Emergent Adverse Events in ≥2% of Galcanezumab-Treated Patients During Double-Blind Treatment: CONQUER1

Treatment-emergent adverse event

PBO
N=230
n (%)

GMB 120 mg
N=232
n (%)

Nasopharyngitis

21 (9.1)

16 (6.9)

Influenza

7 (3.0)

11 (4.7)

Injection site erythema

6 (2.6)

8 (3.5)

Constipation

5 (2.2)

5 (2.2)

Injection site pain

13 (5.7)

5 (2.2)

Upper respiratory tract infection

5 (2.2)

5 (2.2)

Abbreviations: GMB = galcanezumab; PBO = placebo.

One galcanezumab-treated patient discontinued due to an adverse event and 2 serious adverse events were reported each in placebo- and galcanezumab-treated patients (none were considered related to study treatment).1,3

During the Open-Label Extension Phase, Patients Experienced Further Reductions in Monthly Migraine Headache Days 

After completing double-blind treatment, patients could enter an open-label extension in months 4 to 6, in which all patients received galcanezumab 120 mg/month.2

All patients received 2 injections to allow for blinded 240 mg loading dose of galcanezumab at month 3. Specifically,

  • patients randomized to placebo during double-blind treatment received a loading dose of galcanezumab 240 mg, and

  • patients randomized to galcanezumab during double-blind treatment received 1 injection of galcanezumab 120 mg and 1 injection of placebo.2

At the end of open-label treatment (month 6), a mean reduction of

  • 5.6 monthly migraine headache days was seen in the prior galcanezumab group, and

  • 5.2 monthly migraine headache days was seen in the prior placebo group (Figure 1).2

The prior placebo group showed a rapid reduction in monthly migraine headache days following the first galcanezumab injection at month 3.2

Figure 1. Least Squares Mean Change From Baseline in Monthly Migraine Headache Days: CONQUER (Double-Blind and Open-Label Phases)2^

Abbreviations: GMB = galcanezumab; GMB/GMB = patients treated with GMB in double-blind and open-label phases; LS = least squares; PBO = placebo; PBO/GMB = patients treated with PBO in double-blind phase and GMB in open-label phase.
*** p<.0001 vs PBO.
^ Total population (episodic migraine and chronic migraine populations combined).

Reductions in monthly migraine headache days during the double-blind and open-label phases are shown below for patients with

Figure 2. Least Squares Mean Change From Baseline in the Number of Monthly Migraine Headache Days in Episodic Migraine Population: CONQUER (Double-Blind and Open-Label Phases)2

Abbreviations: GMB = galcanezumab; GMB/GMB = patients treated with GMB in double-blind and open-label phases; LS = least squares; PBO = placebo; PBO/GMB = patients treated with placebo in double-blind phase and GMB in open-label phase.
* p<.05 vs PBO/GMB.
*** p<.0001 vs PBO/GMB.

Figure 3. Least Squares Mean Change From Baseline in the Number of Monthly Migraine Headache Days in Chronic Migraine Population: CONQUER (Double-Blind and Open-Label Phases)2

Abbreviations: GMB = galcanezumab; GMB/GMB = patients treated with GMB in double-blind and open-label phases; LS = least squares; PBO = placebo; PBO/GMB = patients treated with placebo in double-blind phase and GMB in open-label phase.
** p<.001 vs PBO/GMB.
*** p<.0001 vs PBO/GMB.

Secondary Endpoint Results: Open-Label Treatment

At the end of open-label treatment (month 6),

  • approximately 53% to 54% of patients had a ≥50% decrease in migraine headache days, and

  • mean MSQ-Role Function Restrictive scores improved from a baseline score of 45 by approximately 27 points on a 100 point scale (Figure 4).2

Figure 4. ≥50% Response and Change From Baseline in MSQ-RFR: CONQUER (Double-Blind and Open-Label Phases)2^

Abbreviations: GMB = galcanezumab; GMB/GMB = patients treated with GMB in double-blind and open-label phases; LS = least squares; MSQ-RFR = role function restrictive domain of Migraine-Specific Quality of Life Questionnaire version 2.1; PBO = placebo; PBO/GMB = patients treated with placebo in double-blind phase and GMB in open-label phase.
*** p<.0001 vs PBO.
^ Total population (episodic migraine and chronic migraine populations combined).

Safety Results During Open-Label Treatment

There were no clinically meaningful changes in any safety parameters during open-label treatment.2

During open-label treatment, the treatment-emergent adverse events experienced by at least 1.5% of patients were

  • nasopharyngitis (4.2%)

  • injection site pain (3.6%)

  • injection site erythema (2.7%)

  • injection site reaction (1.8%), and

  • back pain (1.6%).2

Five patients discontinued due to an adverse event during the open-label phase and 9 serious adverse events were reported (none were considered related to galcanezumab treatment).2

Enclosed Prescribing Information

EMGALITY® (galcanezumab-gnlm) injection, for subcutaneous use, Lilly

References

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).

1. Mulleners WM, Kim B, Láinez MJA, et al. A phase 3, placebo-controlled study of galcanezumab in patients with treatment-resistant migraine: results from the 3-month, double-blind treatment phase of the CONQUER study. J Neurol Sci. 2019;405(suppl):128. World Congress of Neurology abstract WCN19-2248. https://doi.org/10.1016/j.jns.2019.10.1817

2. Detke HC, Reuter U, Lucas C, et al. Galcanezumab in patients with treatment-resistant migraine: results from the open-label phase of the CONQUER phase 3 trial. Poster presented at: 14th European Headache Federation Virtual Meeting (EHF); June 29-July 2, 2020.

3. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

MSQ = Migraine-Specific Quality of Life Questionnaire, Version 2.1

Date of Last Review: July 16, 2020

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