Topline Results From Three Phase 3 Trials Positive for Galcanezumab in Migraine

Deborah Brauser

May 15, 2017

An investigational therapy for the prevention of episodic and chronic migraine met its primary endpoint in topline results from three phase 3 studies released by the agent's manufacturer.

In the EVOLVE-1, EVOLVE-2, and REGAIN trials, patients receiving the monoclonal antibody galcanezumab (LY2951742, Eli Lilly and Co) in 120- or 240-mg/month subcutaneous doses had significant reductions in monthly migraine headache days compared with those who received matching placebo.

Injection-site reactions, including pain, were the most commonly reported adverse events.

On the basis of the combined findings, the company is now planning to submit a Biologics License Application to the US Food and Drug Administration (FDA) in the latter half of this year, according to a statement.

"Encouraging" Results

The self-administered, injectable treatment was designed "to bind to and inhibit the activity of calcitonin gene related peptide (CGRP), which is believed to play a role in migraine and cluster headache," reports the manufacturer.

In both EVOLVE-1 and EVOLVE-2, patients with episodic migraine were randomly assigned to receive, for 6 months, galcanezumab 120 mg or 240 mg once monthly, after a 240-mg starting dose, or matching placebo. All patients reported having 4 to 14 migraine days per month at baseline (average, 9.1 days).

In the first trial, each of the treatment groups had an average reduction of 4.7 and 4.6 days, respectively, compared with 2.8 days for the placebo group. In the second trial, the groups had average reductions of 4.3, 4.2, and 2.3 days, respectively (P < .001 for all comparisons).

In REGAIN, patients with chronic migraine received either of the two treatment doses or placebo for 3 months (average migraine days/month at baseline, 19.4).

Results showed an average reduction of 4.8 and 4.6 days for the 120-mg and 240-mg groups, respectively, compared with 2.7 days for the placebo group (P < .001 for both comparisons).

In all 3 studies, the treatment groups also had significantly greater improvements in response rates and on daily activity measures than did the placebo groups.

Full findings will be presented later this year at scientific meetings and will be submitted to medical journals, notes the company.

It is also assessing the efficacy of the treatment in cluster headache, with phase 3 trial results expected to be release in 2018. Lilly has been granted Fast Track Designation for this indication from the FDA.

At the recent American Academy of Neurology 2017 Annual Meeting, phase 3 results with another CGRP antibody, erenumab (AMG 334, Amgen and Novartis), were presented, showing positive findings for treating episodic migraine in the STRIVE and ARISE trials.

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