Marija Geertsen, Vice President, U.S. Medical Affairs, Lundbeck Shares Insights from 12 Abstracts Presented at AAN 2023

Shots:

Marija spoke about the data on Migraine and Brain Health presented at the 75th Annual Meeting of the AAN 2023. The 12 abstracts included the data from post-hoc and real-world analyses of VYEPTI
She also talked about a medical symposium sponsored by the company “Migraine: Your Patient, Your Partner. Proactive care for high-frequency, worsening disease,” which focuses on studies and techniques for individualizing preventive care to improve collaboration and outcomes
The interview also talks about the data from the additional abstracts which included results from the Harris Poll Migraine report card survey and other trials evaluating VYEPTI

Smriti: Shed some light on the real-world analysis and post hoc data of VYEPTI.

Marija Geertsen: At the 75^th Annual Meeting of the American Academy of Neurology, Lundbeck presented a total of 12 abstracts, including post-hoc and real-world analyses of VYEPTI® (eptinezumab-jjmr), an anti-CGRP monoclonal antibody for the preventive treatment of migraine in adults, as well as the impact of migraine on patients.

Key abstracts that further support the clinical profile of VYEPTI in preventive migraine treatment include:

No wearing off effect observed with VYEPTI in the preventive treatment of migraine

A post-hoc analysis of the pivotal Phase 3 PROMISE-2 (NCT02974153) study evaluating the consistency of weekly migraine frequency during the first dosing interval (12 weeks) found that there was no evidence of “wearing off” of VYEPTI’s preventive benefit prior to the second infusion.

Real-world data reflects magnitude of improvement with VYEPTI treatment in controlled clinical trials

A retrospective analysis of 31 patients with migraine treated with VYEPTI between April and October 2020 found that early clinical experience and clinical improvement are consistent with results reported in controlled clinical trials, with reductions in headache and migraine frequency and associated disability evident during the first six months of treatment.

Survey findings suggest that 75% of patients living with migraine are not averse to IV infusion as a route of administration

A non-interventional, cross-sectional study of 604 patients with self-reported migraine diagnoses who experienced at least five monthly migraine days and had tried at least two prescription migraine treatments was conducted to assess the relative importance of five attributes in the choice of preventive migraine treatment. Except for those preferring auto-injection, all patients – three-quarters of study participants – indicated that they were not averse to IV infusion as a route of administration.

These data continue to show and support the clinical benefit of VYEPTI as a preventive treatment option for people who are highly impacted by migraine. We continue to see the consistency of response to VYEPTI in real-world setting, which aligns with clinical data in the pivotal studies of VYEPTI.

The efficacy and safety of VYEPTI were demonstrated in two phase 3 clinical trials: episodic migraine in PROMISE 1 and chronic migraine in PROMISE 2. VYEPTI met its primary endpoint of decrease in mean monthly migraine days (MMD) over months 1-3 in both episodic and chronic migraine. The safety of VYEPTI was evaluated in 2,076 patients with migraine who received at least one dose of VYEPTI. The most common adverse reactions (≥2 percent and at least 2 percent or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity.

Smriti: Can you tell us a little more about VYEPTI (its MOA, ROA, and its formulation)

Marija Geertsen: VYEPTI® (eptinezumab-jjmr) is the first and only FDA- approved intravenous (IV) infusion for the preventive treatment of migraine in adults. VYEPTI is a CGRP antagonist (anti-CGRP) that is 100% bioavailable following one 30-minute infusion every 3 months. VYEPTI provides fast and powerful migraine prevention that’s proven to reduce monthly migraine days from the very first treatment, with sustained effect over 24 weeks, as demonstrated in two Phase 3 clinical trials: episodic migraine in PROMISE 1 and chronic migraine in PROMISE 2.

Smriti: Tell us about the medical symposium that Lundbeck is sponsoring which is entitled “Migraine: Your Patient, Your Partner. Proactive care for high-frequency, worsening disease.”

Marija Geertsen: The medical symposium focused on studies and techniques for individualizing preventive care plans among highly impacted migraine patients to improve collaboration and outcomes.

During the symposium, the panel discussed that despite recent treatment advancements, approaches to care and unmet needs in migraine management remain relatively consistent, with many highly-impacted patients caught in a cycle of worsening disease with frequent attacks and high acute medication use.

The panel agreed that to help ensure a successful care plan, migraine prevention goals should be individualized to meet various patient needs. At Lundbeck, researching and developing medicines that address the unmet need in brain health is at the core of what we do. The breadth of our data at AAN underscores our commitment to showcasing the safety, efficacy and real-world experience with VYEPTI, and uncovering the stigma, unique perspectives, and concerns that impact the quality of life for those living with migraine disease.

Smriti: Lundbeck mentioned the additional abstracts presented at the AAN 2023. Please brief our readers about the key highlights of those abstracts.

Marija Geertsen: Other data presentations at AAN included:

Results from Harris Poll Migraine Report Card Survey find adults with high-frequency migraine and acute medication overuse more likely to experience stigma

The Harris Poll Migraine Report Card survey evaluated self-reported stigma in 550 U.S. adults with high-frequency headache/migraine (HFM) and acute medication overuse (AMO), defined as at least eight days/month with headache/migraine with at least 10 days/month of acute headache medication use.

The survey found that adults with current HFM and AMO were more likely than those with previous HFM and AMO to always/often experience six of the eight measures on the Stigma Scale for Chronic Illnesses (SSCI-8; P<0.1), while women with current HFM and AMO were more likely to always/often experience seven of the eight SSCI-8 measures (P<0.1). Certain stigma experiences were significantly more common in men, younger adults, and Black adults with current HFM and AMO.

Subgroup analysis of PROMISE-2 reveal adults with a dual diagnosis of chronic migraine and medication-overuse headache reported improved outcomes

PROMISE 2 is a pivotal phase 3, multicenter, randomized, placebo-controlled study that evaluated the efficacy and safety of VYEPTI as a preventive treatment of chronic migraine (CM) in adults. In PROMISE 2, the study population included patients with a dual diagnosis of chronic migraine and medication-overuse headache attributable to overuse of acute medications: triptans, ergotamine, or combination analgesics greater than 10 days per month.

The subgroup analysis found patients with CM treated with VYEPTI experienced lower headache and migraine frequency, migraine-related burden, and acute headache medication use when compared with placebo. VYEPTI treatment improved patient-reported outcomes, including patient perception of disease status.

The safety of VYEPTI was evaluated in 2,076 patients with migraine who received at least one dose of VYEPTI. The most common adverse reactions (≥2 percent and at least 2 percent or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity.

Smriti: Can you please elaborate on the DELIVER Trial that the company has mentioned in the additional abstracts?

Marija Geertsen: The DELIVER (NCT04418765) study is a Phase 3b, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of VYEPTI in patients with chronic or episodic migraine and prior preventive treatment failures.

A post-hoc analysis of 890 patients which evaluated migraine response rates (MRR), an average percentage change from baseline in MMDs over a specified interval, found that most patients who responded to VYEPTI during Weeks 1-12 maintained response during Weeks 13-24, with responder rates further increasing from the first to the second infusion. Approximately one-third of initial non-responders became responders after their second infusion.

Between Weeks 1-12 and 13-24, respectively, ≥30% migraine response rate (MRR) increased from 65.9% to 70.4% (100mg), from 71.0% to 74.5% (300mg), versus 36.9% to 43.1% (placebo; P<0. 0001 for both doses/timepoints vs placebo).
Similarly, the ≥30%, ≥50%, and ≥75% MRRS were generally maintained or further increased over the 24-week period, with more pronounced responder rates observed after the second infusion.
Among patients with <30% response over weeks 1-12, 34.7% (100mg), 30.4% (300mg), vs 21.1% (placebo) achieved ≥30% response over Weeks 13-24, and 16.8% (100mg), 15.2% (300mg), vs 6.5% (placebo) achieved ≥50% response.

The safety profile of VYEPTI observed in the DELIVER study was consistent with the safety profile observed in the pivotal phase III studies with VYEPTI for the preventive treatment of migraine.

Smriti: Is Lundbeck planning to perform trials including combination studies to overcome the contraindications of VYEPTI?

Marija Geertsen: VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients in VYEPTI. Reactions have included anaphylaxis and angioedema.

Providing patients with safe and efficacious treatments is of the utmost importance to Lundbeck. The safety of VYEPTI was evaluated in 2,076 patients with migraine who received at least one dose of VYEPTI. The most common adverse reactions (≥2 percent and at least 2 percent or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. Across VYEPTI development programs, VYEPTI’s safety tolerability is consistent with the approved prescribing information.

We continue to monitor any safety findings related to eptinezumab-jjmr or to any of the excipients in VYEPTI to ensure label is being maintained.

Source: Canva

About the Author:

Marija Geertsen

Marija Geertsen is the Vice President, Medical Affairs at Lundbeck US. She has 15+ years of industry experience in medical leadership roles. Marija translates environmental insights into medical strategies for meaningful drug development and impactful evidence communication. She earned MD from the University of Medicine, Rijeka, Croatia, and an MBA from AVT Business School.