The FDA-approved anti-CGRP therapy from Eli Lilly demonstrated a significant ability to decrease monthly migraine days in patients who did not respond to previous medications.
Results from the phase 3 CONQUER study showed that galcanezumab (Emgality; Eli Lilly) was superior to placebo in the preventive treatment of migraine and was safe and well tolerated in patients who had previous failures with standard migraine treatments.1
Patients who received the 120-mg monthly dose of galcanezumab demonstrated an average of 4.1 fewer monthly migraine headache days from a baseline of 13.4, compared to an average of 1.0 fewer from a baseline of 13.0 in patients with placebo (between-group difference: -3.1; 95% CI, —3.9 to –2.3; effect size, .72; P <.0001).
The treatment proved to be superior to placebo on all key secondary end points and demonstrated a safe tolerable profile that has been consistent with previous studies. Researchers noted that there were no statistically significant differences in treatment-emergent adverse events (TEAEs), except for those reported more frequently in the placebo group. A rash was the cause of 1 discontinuation from a galcanezumab-treated patient.
CONQUER (NCT03559257) was a phase 3 double-blind study, led by senior researcher Holland Detke, PhD, clinical research advisor, Eli Lilly, that included 462 patients aged 18—75 years who met criteria for having chronic or episodic migraine, and had 2–4 migraine preventive medication category failures in the past 10 years.
Patients included in the study were randomized 1:1 to either 120 mg monthly galcanezumab with a 240-mg loading dose (n = 232) or placebo (n = 230). The mean change from baseline in the number of monthly migraine days, captured in a daily electronic diary device, across months 1—3 was recorded as the primary end point. Key secondary end points included >50%, >75%, and >100% reduction in monthly migraine headache days across Months 1—3.
Researchers also gathered data on the Migraine-Specific Quality of Life-Role Function Restrictive domain of patients at Month 3 as an additional secondary end point. The intent-to-treat population and episodic migraine subpopulation were included to evaluate efficacy measures.
Galcanezumab’s efficacy had been previously displayed in patients with episodic migraine in both EVOLVE-1 and EVOLVE-2 studies. The data released December 2019 resulted in significant improvements in monthly migraine headache days across the groups assessed, including a significantly greater number of patients with >50% and >75% reductions.2
Researchers noted a significantly greater reduction of monthly migraine days in patients with prior failures who received 120 mg and 240 mg galcanezumab (P <.0001). Those with ≥1 failure experienced a reduction of 4.0 days (standard error [SE], 0.4) with 120 mg galcanezumab and 4.2 days (SE, 0.5) with 240 mg galcanezumab, compared to 1.3 (SE, 0.4) with placebo.
The therapy was approved in its injection formulation, the same for which it was granted approval for preventive migraine treatment, in September 2018. Galcanezumab also became the first therapy approved for the treatment of episodic cluster headache in adults in June 2019. The basis of the decision for cluster headache came from a phase 3 trial (NCT02397473) which showed treatment with the calcitonin gene-related peptide (CGRP) inhibitor resulted in a statistically significant reduction in the frequency of cluster headache attacks compared with placebo (—8.7 reduction for galcanezumab versus a –5.2 reduction for placebo; P =.036) in Weeks 1 to 3 of the 2-month study period.
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1. Mulleners W, Kim BK, Lainez M, et al. A randomized, placebo-controlled study of galcanezumab in patients with treatment-resistant migraine: double-blind results from the CONQUER study. Neurology. 2020;94(15 Suppl): 0162.
2. Ruff DD, Ford JH, Tockhorn-Heidenreich A, et al. Efficacy of galcanezumab in patients with episodic migraine and a history of preventive treatment failure: results from two global randomized clinical trials. Eur J Neurol. Published online November 6, 2019. doi: 0.1111/ene.14114.