GSK Reports Promising Phase III Findings for Depemokimab in Treating Chronic Rhinosinusitis with Nasal Polyps

GSK Reports Promising Phase III Findings for Depemokimab in Treating Chronic Rhinosinusitis with Nasal Polyps

(IN BRIEF) GSK plc has announced positive results from its Phase III ANCHOR trials for depemokimab, a biologic treatment for chronic rhinosinusitis with nasal polyps (CRSwNP). The trials demonstrated a significant reduction in nasal polyp size and nasal obstruction after 52 weeks compared to placebo. Depemokimab, which is administered every six months, addresses the needs of patients with uncontrolled CRSwNP, a condition affecting around 4% of the global population. Many patients exhibit type 2 inflammation and have limited treatment options. The drug targets interleukin-5 (IL-5), a key cytokine involved in the disease. With promising findings, GSK plans to use the data from the ANCHOR trials for regulatory submissions worldwide, although depemokimab is not yet approved in any market.

(PRESS RELEASE) LONDON, 14-Oct-2024 — /EuropaWire/ — GSK plc (LSE/NYSE: GSK) has revealed encouraging results from the Phase III ANCHOR clinical trials assessing the efficacy and safety of depemokimab in adults suffering from chronic rhinosinusitis with nasal polyps (CRSwNP). Both ANCHOR-1 and ANCHOR-2 trials successfully met their co-primary endpoints, demonstrating a statistically significant reduction in nasal polyp size and nasal obstruction compared to placebo combined with standard care over 52 weeks. This innovative biologic, characterized as ultra-long-acting, is administered just once every six months.

Chronic rhinosinusitis with nasal polyps often presents a myriad of symptoms that are frequently underestimated and inadequately treated. Kaivan Khavandi, Senior Vice President and Global Head of Respiratory/Immunology Research & Development at GSK, emphasized the need for effective treatment options, stating, “Millions of individuals worldwide grapple with uncontrolled CRSwNP, many exhibiting markers of type 2 inflammation. These patients often rely on corticosteroids and face the recurrence of nasal polyps post-surgery. The findings from the ANCHOR studies are promising, highlighting the potential of depemokimab to effectively target and maintain suppression of the inflammation responsible for nasal polyp development and nasal blockage.”

Depemokimab distinguishes itself as the first ultra-long-acting biologic evaluated in Phase III trials, exhibiting a prolonged half-life along with a strong affinity and potency for interleukin-5 (IL-5), a crucial cytokine involved in type 2 inflammation found in elevated levels within nasal polyp tissue. The ability to provide treatment every six months could enhance patient compliance and reduce the burden of frequent clinic visits.

CRSwNP impacts approximately 4% of the global population, with around 40% of affected individuals experiencing uncontrolled symptoms. Characterized by inflammation of the nasal lining, the condition often results in the formation of nasal polyps, leading to various symptoms such as nasal obstruction, facial pressure, loss of smell, and sleep disturbances, which can severely affect an individual’s quality of life.

Moreover, a significant proportion of CRSwNP patients display signs of type 2 airway inflammation, often identifiable through blood eosinophil counts—a biomarker linked to more severe manifestations of the disease. Many of these patients have a history of sinonasal surgery and face a heightened risk of polyp recurrence, leading to increased reliance on oral corticosteroids (OCS) known for their severe side effects.

The data from the ANCHOR trials, alongside findings from the SWIFT-1 and SWIFT-2 studies focusing on depemokimab in severe asthma, will be integral for regulatory submissions globally, although depemokimab has yet to receive approval in any market.

About ANCHOR-1 and ANCHOR-21,2

ANCHOR-1 and ANCHOR-2 were replicate phase III clinical trials assessing the safety and efficacy of depemokimab in patients with CRSwNP. Both were 52-week, randomised, double-blind, parallel group, placebo controlled, multi-centre trials. Number of subjects included in the Full Analysis Set of ANCHOR-1: depemokimab = 143, placebo = 128 and in ANCHOR-2: depemokimab = 129, placebo = 128.

About the depemokimab development programme

Depemokimab’s extended half-life, high potency and high binding affinity for IL-5 means it has the potential to provide sustained inhibition of broad inflammatory functions with dosing once every six-months. The phase III programme includes evaluation of depemokimab in other IL-5 mediated diseases. These include severe asthma,3,13,14 eosinophilic granulomatosis with polyangiitis (EGPA)14 and hypereosinophilic syndrome (HES).15 The first phase III trials in severe asthma, SWIFT-1 and SWIFT-2, have been reported and published in the New England Journal of Medicine.3

GSK in respiratory

GSK continues to build on decades of pioneering work to deliver more ambitious treatment goals, develop the next generation standard of care, and redefine the future of respiratory medicine for hundreds of millions of people with respiratory diseases. With an industry-leading respiratory portfolio and pipeline of vaccines, targeted biologics, and inhaled medicines, we are focused on improving outcomes and the lives of people living with all types of asthma and COPD along with less understood refractory chronic cough or rarer conditions like systemic sclerosis with interstitial lung disease. GSK is harnessing the latest science and technology with the aim to modify underlying disease dysfunction and prevent disease progression.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q2 Results for 2024.

References

1. gov. Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-1). Available at: https://clinicaltrials.gov/study/NCT05274750 Accessed Oct 2024
2. gov. Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2). Available at: https://clinicaltrials.gov/study/NCT05281523 Accessed Oct 2024
3. Jackson DJ, et al. Six Monthly Depemokimab in Severe Asthma With an Eosinophilic Phenotype. NEJM. Published on September 9 at NEJM.org
4. Bachert C, et al. Burden of Disease in Chronic Rhinosinusitis with Nasal Polyps. J Asthma Allergy. 2021;b 11;14:127-134. doi: 10.2147/JAA.S290424. PMID: 33603409; PMCID: PMC7886239.
5. Han JK, et al. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021;9(10):1141-1153.
6. Kato A, et al. Endotypes of chronic rhinosinusitis: Relationships to disease phenotypes, pathogenesis, clinical findings, and treatment approaches. Allergy. 2022;77(3):812-826.
7. De Corso E, et al. How to manage recurrences after surgery in CRSwNP patients in the biologic era: a narrative review. Acta Otorhinolaryngol Ital. 2023;43(Suppl. 1):S3-S13.
8. Chen S, et al. Systematic literature review of the epidemiology and clinical burden of chronic rhinosinusitis with nasal polyposis. Curr Med Res Opin. 2020;36(11):1897-1911.
9. van der Veen J, et al. Real-life study showing uncontrolled rhinosinusitis after sinus surgery in a tertiary referral centre. Allergy. 2017;72(2):282-290.
10. Bachert C, et al. EUFOREA expert board meeting on uncontrolled severe chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics: Definitions and management. J Allergy Clin Immunol. 2021;147(1):29-36.
11. Laidlaw TM, et al. Chronic Rhinosinusitis with Nasal Polyps and Asthma. Allergy Clin. Immunol. 2001;9(3):1133-1141.
12. Silver J, et al. Biologic use and treatment patterns in patients with chronic rhinosinusitis with nasal polyps: a US real-world study. Allergy Asthma Clin Immunol. 2023;19(1):104.
13. gov. An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103) (AGILE). Available at: https://clinicaltrials.gov/study/NCT05243680 Last accessed May 2024.
14. gov. A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype (NIMBLE). Available at: https://clinicaltrials.gov/study/NCT04718389 Accessed May 2024.
15. gov. Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA). Available at: https://clinicaltrials.gov/study/NCT05263934 Accessed May 2024.
16. gov. Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial (DESTINY). Available at: https://clinicaltrials.gov/study/NCT05334368 Accessed May 2024.

Media Contact:

Tim Foley
Vice President, Global Corporate Media Relations
corporate.media@gsk.com
+44 (0)20 8047 5502

SOURCE: GlaxoSmithKline plc