Hansa Biopharma (HNSA) Study result summary

Study background and objectives

• The PAES was a controlled, open-label, multicenter European study evaluating imlifidase (Idefirix) in highly sensitized kidney transplant patients with positive cross-match to deceased donors, including non-comparative reference cohorts.

• The primary objective was to determine one-year graft failure-free survival in patients pre-treated with imlifidase to convert positive to negative crossmatch.

• Secondary objectives included renal function (eGFR), patient survival, and graft survival at one year, as well as safety.

• The study included a treatment group and two non-comparative reference cohorts (concurrent and historical/registry).

• Highly sensitized patients, most with prior transplants, were enrolled across 22 centers in 11 EU countries and the UK.

Study design and patient characteristics

• 51 patients were enrolled in the imlifidase group; 48 were included in the ITT analysis, all highly sensitized (cPRA ≥95%), mean age 49.8 years, 60% male, all on dialysis at baseline.

• The concurrent reference cohort included 61 non-sensitized patients, mean age 55.4, 60.7% male, 88.5% on dialysis.

• Most imlifidase patients received one dose (91.7%), with 8.3% requiring a second dose to achieve cross-match conversion.

• Patient retention exceeded 94% during the study.

• Most imlifidase patients had at least one previous transplant, with one-third having two or more.

Efficacy and safety results

• One-year graft failure-free survival in the imlifidase group was 89.6%–90%, meeting the primary endpoint.

• Patient survival at one year was 97.9%–98% in the imlifidase group.

• Graft survival at one year was 91.6%–92% for imlifidase patients.

• Mean eGFR at one year was 52.4 mL/min/1.73 m² in the imlifidase group.

• Imlifidase was generally well tolerated, with no new safety findings and a profile consistent with previous trials.