D2.450 - EUFOREA/EPOS Criteria Applied to a Diverse CRSwNP Cohort: Post Hoc Findings from Twice-Yearly depemokimab ANCHOR-1/-2 trials

The ANCHOR-1/-2 Phase III trials in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) demonstrated the safety and efficacy of depemokimab, the first ultra-long-acting biologic with enhanced interleukin-5 binding affinity, high potency and an extended half-life, enabling sustained suppression of type 2 (T2) inflammation with twice-yearly dosing. The EUFOREA/EPOS criteria can be used in real-world practice to assess patients’ eligibility for biologics. As the ANCHOR-1/-2 trials recruited a broad population, this post hoc analysis investigated the eligibility of the study population for biologics based on EUFOREA/EPOS criteria, which require prerequisites such as previous CRSwNP surgery. 

ANCHOR-1/-2 randomised adults with inadequately controlled CRSwNP to subcutaneous depemokimab 100 mg or placebo, plus standard of care, once every 26 weeks for 52 weeks. In this post hoc analysis, ANCHOR-1/-2 patients were assessed using EUFOREA/EPOS criteria: evidence of T2 inflammation (baseline blood eosinophil count ≥150 cells/μL or IgE ≥100 IU/mL), need for systemic corticosteroids (SCS; ≥2 courses in prior year), significantly impaired quality of life (baseline Sino-Nasal Outcome Test-22 score ≥40), significant loss of smell (LoS; baseline LoS verbal response scale score >2), comorbid asthma diagnosis. Patients with prior surgery who met ≥3/5 criteria were considered eligible for biologic treatment. 

Of 528 patients included in the analysis, only 291 (55%) were considered eligible for biologics based on EUFOREA/EPOS criteria (depemokimab, n=152/272 [56%]; placebo, n=139/256 [54%]); demographic and clinical characteristics were broadly similar across treatment groups. Overall, 525 (99%) patients met ≥1 criterion. A similar proportion of patients in the depemokimab and placebo groups had evidence of T2 inflammation (93% and 91%), significant LoS (89% and 92%), significantly impaired quality of life (76% and 79%), comorbid asthma (55% and 55%) and SCS need (22% and 24%).  

About half of the ANCHOR-1/-2 cohort met EUFOREA/EPOS criteria for biologic initiation. While these findings suggest that these criteria can identify patients with different treatable characteristics, their use alone may not identify all patients able to benefit from biologics; integrating clinical judgment and individual patient goals can help guide treatment choices.

Funding: GSK (217095/218079; NCT05274750/NCT05281523)