Lilly Announces Positive Topline Results from Phase III CENTURION Study of REYVOW™ (lasmiditan) in Chinese Patients with Migraine

On March 23, 2021, Eli Lilly China announced that the Chinese extension enrollment study (ME2) of the global Phase 3 clinical trial (CENTURION), which evaluated 100 mg and 200 mg REYVOW™ (lasmiditan) for the acute treatment of migraine attacks in adults, was successfully completed in March. The Chinese population achieved positive results highly consistent with those of the main study across both primary endpoints and all key secondary endpoints.

The CENTURION study is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase III trial designed to evaluate the efficacy and safety of REYVOW™ for the acute treatment of migraine in adult patients with or without aura, including the consistency of response across four treated migraine attacks. The study was conducted primarily in Europe, North America, and Asia, and employed an expanded enrollment strategy (ME2) to meet the requirements of regulatory authorities in various countries.

For the two co-primary endpoints—the proportion of patients achieving pain freedom 2 hours after dosing for the first attack, and achieving pain freedom in at least two out of three attacks—data from the Chinese population demonstrated that the REYVOW™ treatment group was superior to the placebo group, consistent with the results of the main study. For multiple key secondary endpoints, including pain freedom and pain relief at 1 hour, pain relief at 2 hours, resolution of the most bothersome symptom (MBS), improvement in migraine-related disability and Patient Global Impression of Change (PGIC), sustained pain freedom and use of rescue medication over 24 hours, sustained pain freedom over 48 hours, and pain relief at 2 hours post-dose in at least two out of three attacks, data from the Chinese population similarly showed that the REYVOW treatment group was superior to the placebo group, highly consistent with the results of the main study.

The CENTURION study showed that the severity of adverse events in the Chinese population was mostly mild or moderate, and the observed safety profile was generally consistent with the results of the main study.

Dr. Li Wang, Senior Vice President of Eli Lilly China and Head of the Drug Development and Medical Affairs Center, stated, “For 25 years, Eli Lilly has been committed to helping patients with headache disorders by developing multiple compounds for the treatment of migraine and cluster headaches. The prevalence of migraine in China is as high as 9.3%¹, yet treatment options remain limited, leaving many unmet clinical needs. Eli Lilly China’s research and development portfolio and strategy for headache medications are closely aligned with the needs of Chinese patients. The CENTURION study is the first global registrational clinical trial to adopt an expanded enrollment strategy for synchronous development, yielding positive results. This represents a solid step forward in Eli Lilly China’s acceleration of bringing innovative medicines to the Chinese market. We look forward to the early launch of REYVOW™ to benefit the vast number of migraine patients in China.”

References:

1. Chinese Medical Association Group (2016) Guide to the prevention and treatment of migraine in China [Chinese]. Chin J Pain Med 22:721–727. http:// doi:10.3969/j.issn.1006-9852.2016.10.001

Responsible Editor: Liu Li

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