Galcanezumab in Patients with Multiple Previous Migraine Preventive Medication Category Failures: Results from the Open-Label Period of the CONQUER Trial

INTRODUCTION: Results from the open-label extension of the phase 3b CONQUER trial are presented to evaluate the effectiveness and safety of galcanezumab, a monoclonal antibody targeting calcitonin gene-related peptide, for up to 6 months in patients with multiple prior migraine preventive treatment failures. METHODS: Patients were 18–75 years old with episodic or chronic migraine and 2–4 standard-of-care migraine preventive medication category failures. After 3 months of randomized treatment with galcanezumab (120 mg/month with 240 mg loading dose; n = 232) or placebo (n = 230), patients entered a 3-month open-label extension (120 mg/month galcanezumab with a blinded 240 mg loading dose for previous-placebo patients). Primary efficacy measure was mean change from double-blind baseline in monthly migraine headache days. RESULTS: A total of 432/449 patients (96%) who entered open-label treatment completed the study. Mean change in monthly migraine headache days in the total population, which was − 1.3 for placebo and − 4.4 for galcanezumab patients at the end of double-blind treatment (p < 0.001), was − 5.2 and − 5.6, respectively, at the end of open-label treatment with galcanezumab. Among patients with episodic migraine, mean change in monthly migraine headache days had been − 0.6 for placebo and − 2.8 for galcanezumab after double-blind treatment (p < 0.001) and was − 4.5 and − 3.8, respectively, after open-label treatment. Among patients with chronic migraine, mean change in monthly migraine headache days had been − 2.5 for placebo and − 6.6 for galcanezumab after double-blind treatment (p < 0.001) and was − 6.5 and − 8.2, respectively, after open-label treatment. Adverse events were similar to those observed during double-blind placebo treatment. Review of data in elderly patients (65–75 years of age) indicated that galcanezumab was well tolerated in this age group, with no safety issues identified. CONCLUSIONS: Galcanezumab was effective and safe during open-label treatment in patients who had experienced failures of previous migraine preventives. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03559257. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12325-021-01911-7.