Eli Lilly and Company recently issued the following announcement.
Eli Lilly and Company announced today results from a post-hoc subgroup analysis which demonstrated efficacy of galcanezumab in patients with episodic and chronic migraine who previously failed to respond to two or more preventive therapies.
Detailed results from a new subgroup analysis of three Phase 3 studies (EVOLVE-1, EVOLVE-2 and REGAIN) evaluating galcanezumab will be presented today as part of the "Best of Headache" platform session at the American Academy of Neurology (AAN) annual meeting in Los Angeles.
Eli Lilly and Company logo. (PRNewsfoto/Eli Lilly and Company)
As previously reported, in these Phase 3 studies, the most commonly-reported adverse events were injection site reactions.
The U.S. Food and Drug Administration (FDA) is reviewing galcanezumab for the prevention of migraine in adults. A decision is expected in the third quarter of 2018.
"Despite available options, research has shown nearly half of patients with migraine discontinue a newly-prescribed preventive therapy within sixty days of prescription, often due to side effects or lack of efficacy," said Christi Shaw, president of Lilly Bio-Medicines. "The research presented today on galcanezumab validates Lilly's decades-long effort to bring a new therapy to market that has the potential to help people experience more migraine-free days, regardless of past preventive therapy use."
EVOLVE-1, EVOLVE-2 and REGAIN were Phase 3, randomized, double-blind, placebo-controlled studies that evaluated the efficacy of two doses of galcanezumab (120 mg and 240 mg) in patients with episodic or chronic migraine. This subgroup analysis evaluated patients treated in the EVOLVE-1 and EVOLVE-2 studies for six months and the REGAIN study for three months. The subgroup analysis reviewed the mean change from baseline in the number of monthly migraine headache days and the proportion of patients with at least a 50 percent reduction in number of monthly migraine headache days in patients who previously failed two or more preventive therapies, using integrated EVOLVE-1 and EVOLVE-2 results and REGAIN results.
In this subgroup analysis, patients treated with both doses of galcanezumab who previously failed two or more preventive therapies experienced a statistically significant reduction in the average number of monthly migraine headache days, and at least a 50 percent reduction in the number of migraine headache days, compared to patients treated with placebo.
EVOLVE-1/ EVOLVE-2 (as evaluated over six months) for patients who failed at least 2 prior preventive medications (N=172):
Average reduction in monthly migraine headache days: 3.45 days for 120 mg and 3.85 days for 240 mg compared to 0.81 days for placebo, p<0.001 for both dosing groups compared with placebo.
Mean percentages of patients with at least 50 percent reduction in monthly migraine headache days: 54.6% for 120 mg and 61.2% for 240 mg compared to 26.2% for placebo, p<0.001 for both dosing groups compared with placebo.
REGAIN (as evaluated over three months) for patients who failed at least 2 prior preventive medications (N=323):
Average reduction in monthly migraine headache days: 5.91 days for 120 mg and 3.30 days for 240 mg compared to 1.44 days for placebo, p<0.01 for both dosing groups compared with placebo.
Mean percentages of patients with at least 50 percent reduction in monthly migraine headache days: 30.4% for 120 mg and 18.3% for 240 mg compared to 9.7% for placebo, p<0.05 for both dosing groups compared with placebo.
Galcanezumab represents the first of three investigational, non-opioid treatments in development as part of Lilly's overall pain portfolio. The portfolio also includes lasmiditan for the acute treatment of migraine and tanezumab, developed in partnership with Pfizer, for the treatment of osteoarthritis pain, chronic low back pain and cancer pain.
Lilly also is evaluating galcanezumab for the treatment of cluster headache with Phase 3 trial results expected in the second quarter of 2018.
About the EVOLVE-1 and EVOLVE-2 Studies
EVOLVE-1 and EVOLVE-2 are six-month Phase 3, randomized, double-blind, placebo-controlled global trials evaluating the safety and efficacy of two doses of galcanezumab administered subcutaneously (120 mg or 240 mg once-monthly, following a 240 mg starting dose) compared with placebo in patients with episodic migraine. To be eligible for the trials, patients must have experienced between four and 14 migraine headache days per month. Patients that participated in these trials had an average of 9.1 migraine headache days per month at baseline. The primary endpoint was the mean change from baseline in monthly migraine headache days over the six-month, double-blind treatment phase.