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 the efficacy and safety of galcanezumab in adult patients with episodic migraine or chronic migraine who had not benefited from 2 to 4 previous migraine preventive medication categories.1

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

Patients were randomized in a 1:1 ratio to receive monthly subcutaneous injections of placebo or galcanezumab 120 mg with a loading dose of 240 mg at the beginning of double-blind treatment.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 (after ≥2 months at maximum tolerated dose), or safety or tolerability reasons. These medication categories included

  • propranolol or metoprolol

  • topiramate

  • valproate or divalproex

  • amitriptyline

  • flunarizine

  • candesartan

  • botulinum toxin A or B (if taken for chronic migraine), or

  • medication locally approved for the 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 

 

Total Population
PBO
n=230

Total Population
GMB 120 mg
n=232

Episodic Migraine
PBO
n=132

Episodic Migraine
GMB 120 mg
n=137

Chronic Migraine
PBO
n=98

Chronic Migraine
GMB 120 mg
n=95

Migraine headache days
per month, mean

13.0

13.4

9.2

9.5

18.1

19.2

Number of monthly days
with any acute headache
medication use at baseline, mean

12.4

12.3

9.4

9.7

16.4

16.0

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

3.3

3.3

3.0

3.2

3.8

3.6

Qualifying medication categories that failed in the past 10 years, %

Topiramate

73

70

75

72

71

68

Amitriptyline

48

47

45

45

53

52

Propranolol or metoprolol

44

47

43

48

45

44

Valproate or divalproex

27

28

30

34

23

20

Botulinum toxin A or B

16

18

9

10

24

28

Candesartan

11

9

11

8

11

12

Flunarizine

10

15

10

15

10

16

Migraine frequency

Low episodic, %a

16

15

27

26

NA

NA

High episodic, %b

42

44

73

74

NA

NA

Chronic, %c

43

41

NA

NA

100

100

MSQ-RFR, mean

44.0

45.8

46.5

48.6

40.5

41.9

MIDAS, mean

51.0

50.9

37.1

41.3

69.6

64.7

Abbreviations: GMB = galcanezumab; MIDAS = Migraine Disability Assessment total score; MSQ-RFR = Migraine-Specific Quality-of-Life Questionnaire Role Function-Restrictive domain score; NA = not applicable; PBO = placebo.

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

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

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

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

230

-1.0

GMB 120 mg

232

-4.1b

Episodic migraine

PBO

132

-0.3

GMB 120 mg

137

-2.9b

Chronic migraine

PBO

98

-2.2

GMB 120 mg

95

-6.0b

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

a Months 1 to 3.

b p<.0001 vs PBO.

Results at each month for the entire population are shown in Figure 1. Results were consistent in the episodic and chronic migraine subpopulations (Figure 2 and Figure 3).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).1

A greater percentage of patients treated with galcanezumab achieved response rate thresholds (reduction from baseline in monthly migraine headache days) at ≥50%, ≥75%, and 100% compared with placebo in the total population (p<.0001). Additionally, compared with placebo, significantly greater mean percentages of patients in the galcanezumab group achieved response rate thresholds of

  • 50%, ≥75%, and 100% in the episodic migraine subgroup, and

  • 30%, ≥50%, and 75% in the chronic migraine subgroup.1

Galcanezumab was superior to placebo across all populations in reducing

  • restrictions on daily functioning and disability

  • number of monthly days with acute headache medication use, and

  • number of monthly migraine headache days with acute headache medication use.1

Galcanezumab was also superior to placebo in reducing the number of monthly migraine headache days in patients who had previously had failure of 2, 3, or 4 migraine preventive medication categories, with results indicating increasing magnitude of effect as number of medication category failures increased.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

Table 3 provides details of treatment-emergent adverse events experienced by patients during double-blind treatment.

Table 3. Treatment-Emergent Adverse Events During Double-Blind Treatment: CONQUER1


PBO
n=230
n (%)

GMB 120 mg
n=232
n (%)

Anticipated TEAEsa



Any injection site related adverse event

23 (10)

16 (7)

Constipation

5 (2)

5 (2)

Vertigo

4 (2)

1 (<1)

Pruritus

1 (<1)

1 (<1)

Urticaria

1 (<1)

0

All other TEAEs ≥1.5% in any group

Nasopharyngitis

21 (9)

16 (7)

Influenza

7 (3)

11 (5)

Upper respiratory tract infection

5 (2)

5 (2)

Back pain

6 (3)

4 (2)

Bronchitis

2 (1)

4 (2)

Fatigue

1 (<1)

4 (2)

Gastroenteritis

3 (1)

4 (2)

Nausea

5 (2)

4 (2)

Oropharyngeal pain

2 (1)

4 (2)

Sinusitis

5 (2)

4 (2)

Urinary tract infection

4 (2)

2 (1)

Migraine

5 (2)

1 (<1)

Insomnia

5 (2)

0

Abbreviations: GMB = galcanezumab; PBO = placebo; TEAE = treatment-emergent adverse event.

a Anticipated TEAEs are those adverse drug reactions previously identified in phase 3 migraine prevention studies.

One galcanezumab-treated patient discontinued due to an adverse event (moderate rash generalized), which resolved after study discontinuation.1 Two serious adverse events were reported each in placebo- and galcanezumab-treated patients (none were considered related to study treatment).1,2

No clinically meaningful differences were observed between treatment groups in treatment-emergent abnormal changes in

  • laboratory parameters

  • vital signs

  • weight, or

  • electrocardiogram parameters.1

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.3

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.3

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).3

The prior placebo group showed a rapid reduction in monthly migraine headache days following the first galcanezumab injection at month 3.3

Figure 1. Least Squares Mean Change From Baseline in Monthly Migraine Headache Days: CONQUER (Double-Blind and Open-Label Phases)3^

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 as follows 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)3

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)3

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).3

Figure 4. ≥50% Response and Change From Baseline in MSQ-RFR: CONQUER (Double-Blind and Open-Label Phases)3^

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

No clinically meaningful changes were observed in any safety parameters during open-label treatment.3

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%).3

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).3

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 BK, Láinez MJA, et al. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020;19(10):814-825. http://dx.doi.org/10.1016/S1474-4422(20)30279-9

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

3. 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 (EHF Virtual); June 29-July 2, 2020.

Glossary

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

Date of Last Review: September 21, 2020


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