35-OR: Lantidra, First FDA-Approved Cellular Therapy to Treat Type 1 Diabetes

Despite intensive insulin therapy and frequent blood sugar monitoring, a subset of patients with type 1 diabetes (T1D) still suffer from debilitating symptoms, including severe hypoglycemia and hypoglycemia unawareness, and are left susceptible to the secondary complications of T1D. For T1D patients unable to achieve target hemoglobin A1c (HbA1c) despite intensive diabetes management and education, Lantidra is a treatment option to restore glycemic control, eliminate hypoglycemia episodes, and reduce or eliminate exogenous insulin injections. Lantidra is an FDA-approved allogeneic cellular therapy derived from donor pancreatic islet cells. Compared to whole pancreas transplantation, administration of Lantidra (minimum dosage: 5,000 islet equivalent/kg body weight) into the hepatic portal vein via percutaneous or transvenous transhepatic access, presents a safer and more minimally invasive surgical procedure. The efficacy and safety of Lantidra were examined in two core clinical studies, UIH-001 (Phase 1/2) and UIH-002 (Phase 3), at a single center (Pooled Population; n=30). Patients were screened to ensure an appropriate benefit-risk profile and received 1 to 3 Lantidra administrations. 19/30 patients (63%) met the composite efficacy endpoint (i.e., HbA1c ≤6.5% and absence of severe hypoglycemic events (SHEs) through 1 year after last transplant) and 20/30 (67%) were insulin independent at 1 year after last transplant. Importantly, improvements in glycemic control persisted. Two-thirds of patients assessed exhibited good glycemic control after 6 years. Lantidra demonstrated a safety profile consistent with known risks of the transplant procedure and concomitant medication use, particularly long-term use of immunosuppressants. The benefits of Lantidra outweigh the risks in T1D patients who have failed state-of-the-art insulin therapy. Lantidra fills a significant medical need, is effective at restoring good glycemic control in patients, and improves patient quality of life.