Researchers have found that immunosuppressant treatment with an mTOR inhibitor and prednisone plus immunotherapy with cemiplimab-rwlc may result in durable responses and no allograft loss in adult kidney transplant recipients with advanced cutaneous squamous cell carcinoma, according to new findings published by Hanna et al in the Journal of Clinical Oncology. Researchers enrolled 12 eligible patients into the small single-center phase I trial between November 2020 and March 2023. The patients were cross-tapered at 7 to 10 days prior to starting immunotherapy from their existing immunosuppressive regimen to an mTOR inhibitor (sirolimus or everolimus) with the goal trough of 4 to 6 ng/mL and prednisone at 10 mg once daily. Once mTOR inhibitor trough levels were achieved, the patients received cemiplimab at 350 mg every 21 days for up to 35 doses. The primary endpoint of the trial was the rate of kidney rejection. Among 11 evaluable patients, 46% (n = 5) had objective responses to cemiplimab (90% CI = 22%–73%), including complete responses in 27% (n = 3). Median response duration was 11.4 months (range = 4.9–29.7 months), with response ongoing at the time of analysis in three patients; two of them had responses exceeding 12 months. Median progression-free survival was 22.5 months (90% confidence interval [CI] = 1.2–29.8 months). Median overall survival was 22.5 months (90% CI = 2.9–29.8 months). Treatment-related grade ≥ 3 adverse events occurred in 42% (n = 5) of patients, and 8% (n = 1) died from angioedema and anaphylaxis attributed to mTOR inhibitor cross-taper. No kidney rejection or loss was observed. The study authors concluded: “mTOR inhibitor and corticosteroids represent a favorable immunosuppressive regimen for kidney transplant recipients with advanced cutaneous squamous cell carcinoma receiving immunotherapy.”
February 14, 2024