In a small single-center phase I trial reported in the Journal of Clinical Oncology, Glenn J. Hanna, MD, and colleagues found that immunosuppressant treatment with an mTOR inhibitor and prednisone plus immunotherapy with cemiplimab-rwlc resulted in durable responses and no allograft loss in adult kidney transplant recipients with advanced cutaneous squamous cell carcinoma.
Glenn J. Hanna, MD
Study Details
Twelve eligible patients were enrolled into the trial at Dana-Farber Cancer Institute between November 2020 and March 2023. Patients were cross-tapered at 7 to 10 days before starting immunotherapy from their existing immunosuppressive regimen to an mTOR inhibitor (sirolimus or everolimus) with a goal trough of 4 to 6 ng/mL and prednisone at 10 mg once daily. Once mTOR inhibitor trough levels were achieved, patients received cemiplimab at 350 mg every 21 days for up to 35 doses. The primary endpoint was the rate of kidney rejection.
Key Findings
No kidney rejection or loss was observed among the 12 patients.
Among 11 evaluable patients, 5 (46%, 90% confidence interval [CI] = 22%–73%) had objective responses to cemiplimab, including complete response in 3. Median response duration was 11.4 months (range = 4.9–29.7 months), with response ongoing at the time of analysis in 3; 2 had responses exceeding 12 months.
Median progression-free survival was 22.5 months (90% 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 five patients (42%), including diarrhea, infection, and metabolic disturbances. One patient died of angioedema and anaphylaxis attributed to mTOR inhibitor cross-taper.
The investigators concluded, “mTOR inhibitor and corticosteroids represent a favorable immunosuppressive regimen for kidney transplant recipients with advanced cutaneous squamous cell carcinoma receiving immunotherapy. This combination resulted in durable antitumor responses with no kidney rejection events.”
Dr. Hanna, of the Department of Medical Oncology, Dana-Farber Cancer Institute, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was funded by Regeneron Pharmaceuticals. For full disclosures of the study authors, visit ascopubs.org.
