The investigative monoclonal antibody has more data backing its efficacy, safety, and tolerability across 2 dose regimens.
David W. Dodick, MD
Investigative migraine therapy galcanezumab has reported more statistically significant benefits across multiple relevant outcomes in a randomized, placebo-controlled trial that tested 2 different doses of the drug against placebo.
In the most recent results from the Evaluation of LY2951742 in the Prevention of Episodic Migraine 1 (EVOLVE-1) trial, researchers found new clinical benefits for both 120 mg and 240 mg galcanezumab versus placebo in patients with episodic migraines. Patients were randomized 2:1:1 to receive either monthly doses of placebo or either regimen of galcanezumab, respectively.
Led by author Virginia L. Stauffer, PharmD, of Eli Lilly and Company, and corresponding author David W. Dodick, MD, Department of Neurology, Mayo Clinic, Phoenix Arizona, researchers sought the encompassing efficacy and safety of the monoclonal antibody calcitonin gene-related peptide (CGRP) inhibitor in preventing migraines over 6 months.
The trial lasted from January 11, 2016 to March 22, 2017, and featured 862 patients aged 18-65 years old. Patients were required to have at least 1 year of migraine history, 4-14 migraine headache days per month, and at least 2 mean migraine attacks per month within the past 3 months, and were diagnosed prior to age 50.
Researchers gauged patients for overall mean change from baseline in monthly migraine headache day rates during treatment period, with secondary outcomes set at reductions of at least 50%, 75% and 100% in monthly migraine headache days, migraine headache days with acute medication use, and scores from various tests (Migraine-Specific Quality of Life; Patient Global Impression of Severity; and Migraine Disability Assessment).
On average, patients administered both 120 mg (n = 213) and 240 mg (n = 212) monthly galcanezumab achieved primary objective, significantly reducing monthly migraine headache days by 4.7 days and 4.6 days, respectively, compared to placebo patients’ mean 2.8-day reduction (P < 0.001). Researchers noted the treatment’s reduction could equate to a supplemental 8 weeks of migraine-free days following 6 months of treatment.
The effects were also reaching to a majority of all patients treated with galcanezumab — 131 (62.3%) of patients given 120 mg dose and 126 (60.9%) of patients given 240 mg dose had a monthly headache day reduction of at least 50% over 6 months of treatment.
Both study duration and patient sample size at study’s end contributed to results that are more indicative of the therapy than previous phase 2 trials, researchers noted.
“The 6-month duration of treatment allowed for an appropriate assessment of response durability,” researchers wrote. “This longer treatment duration may have contributed to a higher rate of discontinuations during treatment than those observed in other studies of CGRP monoclonal antibodies with only 3-month treatment periods.”
Researchers found no meaningful differences between the 2 galcanezumab doses on measures of efficacy, and both treatment groups reported a treatment completion rate of 83.1%. Incidence of discontinuation due to adverse events was less than 5% among all groups.
These new trial results come just a month following 3 study results showed galcanezumab’s significant reduction in monthly migraine days for patients who previously attempted at least 2 preventive treatments. At the time, researchers were addressing the previously-held notion that such patients may be more treatment-resistant to such therapy.
Eli Lilly and Company’s Biologics License Application (BLA) to review galcanezumab as a preventive migraine therapy in adult patients was accepted by the US Food and Drug Administration (FDA) in December 2017. Its currently-estimated decision date is for Q3 of 2018.
With EVOLVE-1 results included in its application, galcanezumab looks primed to join recently-approved erenumab (Aimovig) among the new class of marketed CGRP inhibitors for the prevention of migraines.
“These data provided consistent, clinically meaningful evidence that treatment with galcanezumab reduced migraine frequency and migraine-related disability and improved patient functioning,” researchers concluded.
The study, "Evaluation of Galcanezumab for the Prevention of Episodic Migraine," was published online in JAMA Tuesday.
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