Cemiplimab for Kidney Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma

Area of Science:

• Oncology
• Immunology
• Transplantation

Background:

• Cutaneous squamous cell carcinoma (CSCC) is a common cancer in solid organ transplant recipients.
• Immunotherapy, such as PD-1 inhibitors, shows promise for advanced CSCC but raises concerns about allograft rejection in transplant patients.
• Chronic immunosuppression required for transplant recipients may impact the efficacy of PD-1 inhibitors.

Purpose of the Study:

• To evaluate the safety and efficacy of cemiplimab in kidney transplant recipients (KTRs) with advanced CSCC.
• To assess the rate of kidney rejection as a primary endpoint.
• To determine response rates, duration of response, and survival as secondary endpoints.

Main Methods:

• A phase I study administered cemiplimab intravenously every 3 weeks to KTRs with advanced CSCC.
• Patients underwent a cross-taper to a mammalian target of rapamycin (mTOR) inhibitor and pulsed corticosteroids.
• Response was assessed every 8 weeks, with a primary endpoint of kidney rejection rate.

Main Results:

• Twelve KTRs were treated; no instances of kidney rejection or loss were observed.
• Five of 11 evaluable patients (46%) showed a response to cemiplimab, with two achieving durable responses lasting over a year.
• Treatment-related adverse events occurred in 42% of patients; one death was attributed to angioedema and anaphylaxis from the mTOR inhibitor cross-taper.

Conclusions:

• A combination of mTOR inhibitor and corticosteroids is a suitable immunosuppressive strategy for KTRs with advanced CSCC undergoing immunotherapy.
• Cemiplimab, in conjunction with this regimen, demonstrated durable antitumor responses without compromising kidney allograft survival.
• This approach offers a potential treatment option for KTRs with advanced CSCC, addressing both cancer and transplant considerations.