Emgality® (Galcanezumab)

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Galcanezumab: Biomarker Changes

There are currently no commercially accepted biomarkers for diagnosing migraine or episodic cluster headache, or monitoring treatment efficacy.

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CGRP Plasma Levels in the Phase 3 Clinical Trials

This medical response may not completely match the information in the current local labeling for GALCANEZUMAB. Please see local labeling for approved label information.

Although CGRP levels were measured during the galcanezumab phase 3 clinical trials, there are currently no

  • accepted biomarkers for chronic or episodic migraine, or episodic cluster headache
  • commercial assays available to detect CGRP levels, or
  • recommendations in the galcanezumab prescribing information to measure CGRP levels at baseline or during treatment with galcanezumab.1-3

In the phase 3 double-blind, placebo-controlled migraine prevention and episodic cluster headache studies,4-7 total CGRP concentrations increased after galcanezumab administration compared to placebo. This indicated that the antibody was

Higher total CGRP concentrations in galcanezumab-treated patients were associated with a greater change from baseline compared to placebo in reduction of

  • monthly migraine headache days for patients with episodic or chronic migraine,8 and
  • episodic cluster headache attack frequency.1

CGRP Plasma Concentration

A drug-tolerant CGRP assay was used in the clinical program for migraine prevention and treatment of episodic cluster headache to measure total CGRP concentrations (total CGRP = galcanezumab-bound CGRP + free CGRP).1,8

When galcanezumab is administered, the premise is that

  • CGRP will bind to galcanezumab, and
  • the amount of free CGRP that is available to interact with the CGRP receptors will be reduced.1,8

Upon galcanezumab administration, galcanezumab-bound CGRP is expected to take on the disposition characteristics of galcanezumab resulting in

  • a lower clearance than free CGRP, and
  • an increase in total CGRP concentration.1,8
Total CGRP Plasma Mean Concentrations (ng/mL) at End of Double-Blind Treatment in the Phase 3 Migraine Prevention Studies1

 

PBO

GMB 120 mg

GMB 240 mg

EVOLVE-1a

0.89

4.25

5.13

EVOLVE-2a

0.54

3.93

4.98

REGAINb

0.53

4.02

4.85

Abbreviations: CGRP = calcitonin gene-related peptide; GMB = galcanezumab; PBO = placebo.

aRepresents total CGRP plasma concentrations at month 6.

bRepresents total CGRP plasma concentrations at month 3.

Total CGRP Plasma Mean Concentrations (ng/mL) at End of Double-Blind Treatment in the Episodic Cluster Headache Study1

 

PBO

GMB 300 mg

CGALa

0.327

4.60

Abbreviations: CGRP = calcitonin gene-related peptide; GMB = galcanezumab; PBO = placebo.

aRepresents total plasma CGRP concentrations at month 2.

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Durham P, Papapetropoulos S. Biomarkers associated with migraine and their potential role in migraine management. Headache. 2013;53(8):1262-77. http://dx.doi.org/10.1111/head.12174.

3Emgality [package insert]. Indianapolis, IN: Eli Lilly and Company; 2019.

4Stauffer VL, Dodick DW, Zhang Q, et al. Evaluation of galcanezumab for the prevention of episodic migraine: the EVOLVE-1 randomized clinical trial. JAMA Neurol. 2018;75(9):1080-1088. http://dx.doi.org/10.1001/jamaneurol.2018.1212

5Skljarevski V, Matharu M, Millen BA, et al. Efficacy and safety of galcanezumab for the prevention of episodic migraine: results of the EVOLVE-2 phase 3 randomized controlled clinical trial. Cephalalgia. 2018;38(8):1442-1454. http://dx.doi.org/10.1177/0333102418779543

6Detke HC, Goadsby PJ, Wang S, et al. Galcanezumab in chronic migraine: the randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018;91(24):e2211-e2221. http://dx.doi.org/10.1212/WNL.0000000000006640

7Goadsby PJ, Dodick DW, Leone M, et al. Trial of galcanezumab in prevention of episodic cluster headache. N Engl J Med. 2019;381(2):132-141. http://dx.doi.org/10.1056/NEJMoa1813440

8Kielbasa W, Helton DL. A new era for migraine: Pharmacokinetic and pharmacodynamic insights into monoclonal antibodies with a focus on galcanezumab, an anti-CGRP antibody. Cephalalgia. 2019;39(10):1284-1297. http://dx.doi.org/10.1177/0333102419840780

Glossary

CGRP = calcitonin gene-related peptide

Fecha de la última revisión: 2020 M03 09


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