Galcanezumab Reduced Monthly Migraine Headache Days for Treatment-Resistant Cases

Sheena Aurora, MD

In results from 3 studies, galcanezumab (GMB) demonstrated a significant reduction in monthly migraine days for participants who failed and those who did not fail ≥2 previous preventative treatments. An analysis of the sub-group who failed ≥2 prior preventatives suggested better results compared to placebo for this group due to a much lower placebo effect.

“In this subgroup analysis, where there’s been a previous belief that these patients may be more treatment-resistant to therapy, we actually showed better effect size,” said Sheena Aurora, MD, medical fellow and migraine launch leader for Eli Lilly and Company, who presented the results.

"At the highest level, any healthcare provider will want to know that galcanezumab has a positive efficacy profile for people living with a difficult-to-treat condition," added Aurora. "This post-hoc subgroup analysis reaffirms galcanezumab’s potential as preventive option for people living with migraine, regardless of past preventive therapy use."

Galcanezumab is a humanized monoclonal antibody that binds selectively to calcitonin gene-related peptide. Doses of 120mg or 240mg/month were tested in 3 double-blind, randomized, phase 3 studies. EVOLVE-1 and EVOLVE-2 (n=1773) included patients with episodic migraine and lasted 6 months, while REGAIN (n=1113) studied patients with chronic migraine over 3 months. Patients who had previously failed ≥2 preventative treatments accounted for 9.8% of EVOLVE participants (n=172) and 29.5% of REGAIN (n=323) participants.

"Like other recurrent and chronic pain conditions, migraine has a significant impact on a person's physical, social and economic well-being, yet there remains both a stigma and an unmet need for treatment options for this debilitating disease," said Robert Conley, MD, Distinguished Lilly Scholar and Lilly global development leader for migraine therapeutics.

For the subgroup analysis, patients treated with either dose of galcanezumab experienced a significant mean reduction of monthly migraine headache days (MHD) and at least a 50% reduction in the number of migraine headache days, compared to participants treated with placebo.

For patients who failed prior preventives, average reductions in monthly MHD in EVOLVE were placebo: 0.81 days, GMB_120mg: 3.45 days, and GMB_240mg: 3.85 days, and in REGAIN reductions were placebo: 1.44 days, GMB_120mg: 5.91 days, and GMB_240mg: 3.30 days.

The percentages of patients in the treatment-resistant subgroup with at least a 50% reduction in monthly MHD in EVOLVE were placebo: 26.2%, GMB_120mg: 54.6%, and GMB_240mg: 61.2%. In REGAIN these trends continued with placebo: 9.7%, GMB_120mg: 30.4%, and GMB_240mg: 18.3%.

The most common reported adverse events in the EVOLVE and REGAIN studies were injection-site reactions.

"We are excited about the potential to deliver access of new options to people living with migraine who have not yet tried, or found, an effective preventive therapy and hope to soon be able to equip physicians with new choices that may help address the unique and varied needs of those with migraine," said Aurora.

The US Food and Drug Administration (FDA) previously accepted a Biologics License Application to review galcanezumab for the prevention of adults with migraine. Whether the FDA will approve galcanezumab remains to be seen. Lilly expects a decision from the FDA in Q3 of 2018.

The presentation, “Efficacy of Galcanezumab in Patients Who Failed to Respond to Preventives Previously: Results from EVOLVE-1, EVOLVE-2 and REGAIN Studies,” was given at the 2018 Annual Meeting of the American Academy of Neurology in April 2018.

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