Imlifidase demonstrated 90% patient survival and 82% graft survival at five years in extended pooled analysis with data from 17-HMedIdeS-14 study in kidney transplant patients – Hansa Biopharma

Hansa Biopharma announced results from an extended pooled analysis using data from the 17-HMedIdeS-14 study, an international long-term follow-up study of patients who have received a kidney transplant following desensitization with imlifidase, showing sustained positive outcomes out to 5 years in the majority of highly sensitized patients who received an imlifidase-enabled kidney transplant.

After 5 years, the patient survival rate was 90% (three deaths occurring between six months and one year, and no deaths occurring between one and five years) and graft survival (death censored) was 82%, in line with outcomes seen at 3-years post-transplant. At five years, mean estimated glomerular filtration rate (eGFR) was 50 mL/min/m2. eGFR is a measure of how well the kidneys are working in the body.

Søren Tulstrup, President and CEO, Hansa Biopharma said, “The results from this study confirm the important role imlifidase plays in desensitization in kidney transplantation and further supports the clinical benefit of enabling HLA-incompatible kidney transplantation with imlifidase. Conditionally approved and marketed in Europe as Idefirix (imlifidase), we believe it is a paradigm shifting treatment in kidney transplantation – one that will positively impact patient outcomes and ensure that highly sensitized patients waiting for a kidney have access to transplantation.”

The 17-HMedIdeS-14 study included patients who consented to long-term follow-up and had previously received an imlifidase-enabled transplant in Hansa’s phase II studies. The 5-year extended pooled analysis is a continuation of the analysis at 3-years of crossmatch positive only patients published in the American Journal of Transplantation. Hansa is continuing to analyze the data from 17-HMedIdeS-14 along with the extended pooled analysis and plans to share further data in 2024.

Tomas Lorant, MD PhD, Associate Professor of Transplant Surgery, Uppsala University Hospital, Uppsala, Sweden, said, “It is encouraging to see the outcome of patients five years out from an incompatible kidney transplant and its consistency with the 3-year data that was published in 2021. Despite the high-risk immunological profile of these patients, we see stable long-term outcomes both on graft survival and patient survival, not different from what we otherwise see in compatible kidney transplantation.”

Stanley Jordan, MD, FASN, FAST, Professor of Pediatrics & Medicine and Director of Nephrology & Transplant Immunology, Cedars-Sinai Medical Center, Los Angeles, CA, said, “These results reinforce the case for HLA-incompatible transplantation following desensitization with imlifidase being a viable and concrete option for patients on the waitlist who are highly sensitized and predicted to have low likelihood to access a compatible kidney offer, removing their dependency on dialysis treatment.”

Imlifidase is a promising new strategy for desensitization of transplant patients with donor-specific anti-HLA (Human Leukocyte Antigens) antibodies (DSAs). Highly sensitized patients have high levels of preformed antibodies that can damage the transplant. Once they inactivated with imlifidase, there is a window of opportunity for the transplant to take place. By the time the body starts to synthesize new IgG, the patient will be receiving post-transplant immunosuppressive therapy to reduce the risk of organ rejection.

See-“Outcomes at 3 years posttransplant in imlifidase-desensitized kidney transplant patients”-
Christian Kjellman, Angela Q. Maldonado, Kristoffer Sjöholm, Bonnie E. Lonze, Robert A. Montgomery,
Anna Runström, et al,. American Journal of Transplantation Volume 21, Issue 12.First published: 08 July 2021.