Novartis today announced that the New England Journal of Medicine (NEJM) published positive results from the six-month Phase III STRIVE study evaluating erenumab in the prevention of episodic migraine (defined in STRIVE as 4 to 14 migraine days per month). Erenumab delivered clinically meaningful and statistically significant differences from placebo for all primary and secondary endpoints including those measured by the novel, validated Migraine Physical Function Impact Diary (MPFID). Treatment with erenumab was well tolerated, with a safety profile comparable to placebo. Erenumab is the first and only fully human monoclonal antibody of its kind, designed to specifically block the CGRP receptor, which plays a critical role in migraine activation.
STRIVE enrolled 955 patients, who were randomized to receive either placebo or subcutaneous erenumab 70mg or 140mg once a month, for six months. Patients taking erenumab at the higher dose experienced a significant 3.7-day reduction in monthly migraine days from the baseline of 8.3 days (3.2-day reduction with 70mg, 1.8-day reduction with placebo, both p<0.001). Fifty percent of patients taking erenumab 140mg had their migraine days cut by at least half, representing a significantly higher likelihood of achieving this response compared to placebo (43.3% with 70mg; 26.6% with placebo, both p<0.001; odds ratios of 2.8 and 2.1 respectively for 140mg and 70mg). STRIVE endpoints were assessed from baseline to the average of the last three months (months 4, 5, 6).
Principal Investigator, Peter Goadsby, M.D., Ph.D., FAHS, Director, NIHR-Wellcome Trust King’s Clinical Research Facility and Professor of Neurology at King’s College Hospital, London, shared his view on what the findings could mean for those with migraine, “STRIVE is the first fully reported phase III study of the CGRP pathway monoclonal antibodies, and it clearly shows that blocking this pathway can reduce the impact of migraine,” Prof. Goadsby said, “The results of STRIVE represent a real transition for migraine patients from poorly understood, repurposed treatments, to a specific migraine-designed therapy. STRIVE, as with the monoclonal antibody developments generally, represents an incredibly important step forward for migraine understanding and migraine treatment.”
“The results of the STRIVE study add to the evidence for the significant, consistent benefits of erenumab seen across the spectrum of chronic and episodic migraine, including patients who failed on previous preventive treatments,” said Vas Narasimhan, Global Head of Drug Development and Chief Medical Officer for Novartis. “People with migraine are missing out due to this debilitating neurological disease and are in need of safe, tolerable and effective preventive treatments. We are committed to bringing this much-needed treatment option to patients as soon as possible.”
Other secondary endpoint results from the study include:
· Patients taking erenumab had significant reductions in the number of days per month using an acute or “rescue” migraine-specific medication (1.6 days for 140mg group and 1.1 days for 70mg compared to 0.2-day reduction with placebo; both p<0.001).
· Results from the MPFID showed erenumab delivered meaningful benefits by reducing the impact of migraine on patients’ everyday activities, such as getting ready for the day, doing household chores or activities requiring concentration (5.9 points, 140mg; 5.5 points, 70 mg; 3.3 points, placebo; both p<0.001).
· MPFID scores in physical impairment, such as getting out of bed or activities requiring physical effort, were also significantly reduced with erenumab (4.8 points, 140mg; 4.2 points, 70 mg; 2.4 points, placebo; both p<0.001).
In STRIVE, more than 90% of patients taking erenumab completed the study. Adverse reactions leading to discontinuation of treatment occurred in 2.2% of erenumab-treated patients and in 2.5% of patients receiving placebo. STRIVE contributes to an extensive body of evidence in support of the efficacy, safety and tolerability profile of erenumab, including four placebo-controlled Phase II and Phase III clinical studies involving more than 2,600 patients, as well as an ongoing open-label extension up to five years in duration.
Erenumab is the first investigational therapy targeting the CGRP pathway to have received FDA and EMA regulatory filing acceptance to date. The STRIVE study is one of the pivotal trials included in the US and EU regulatory applications under review for erenumab. If approved, Novartis and Amgen will co-commercialize erenumab in the US. Amgen has exclusive commercialization rights to the drug in Japan and Novartis has exclusive rights to commercialize in the rest of the world.