Cemiplimab for Kidney Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma

Author(s): Glenn J. Hanna, MD1,Harita Dharanesswaran, BS2,Anita Giobbie-Hurder, MS3,John J. Harran, RN2,Zixi Liao, RN2,Lori Pai, MD4,Vatche Tchekmedyian, MD5,Emily S. Ruiz, MD2,Abigail H. Waldman, MD2,Chrysalyne D. Schmults, MD2,Leonardo V. Riella, MD, PhD6,Patrick Lizotte, PhD7,Cloud P. Paweletz, PhD7,Anil K. Chandraker, MD, MBCHB8,Naoka Murakami, MD, PhD9,Ann W. Silk, MD10
Source: https://doi.org/10.1200/JCO.23.0149
Anjan J Patel MD

Dr. Anjan Patel's Thoughts

Granted, this is a small study of 12 patients, it is nice to see an official report indicating safety regarding the use of CPI in the setting of advanced cutaneous SCC’s secondary to chronic immunosuppressive therapy after renal transplant. Patients were treated with steroids and rapamycin before/after the cemiplimab infusions, and no patients had rejection events.


Cemiplimab is approved for treating locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC). Solid organ transplant recipients have been excluded from immunotherapy trials, given concern for allograft rejection despite their increased risk of skin cancers. Chronic immunosuppression is necessary to prevent organ rejection but may attenuate antitumor response with PD-1 inhibitors.


We report a phase I study of cemiplimab for kidney transplant recipients (KTRs) with advanced CSCC. After cross-taper to a mammalian target of rapamycin (mTOR) inhibitor and pulsed dose corticosteroids (prednisone 40 mg once daily, the day before and on days 1-3 of each cycle, followed by 20 mg once daily on days 4-6, then 10 mg once daily until the day before each subsequent cycle), patients received cemiplimab 350 mg intravenously once every 3 weeks for up to 2 years and were assessed for response every 8 weeks. The primary end point was the rate of kidney rejection, with key secondary end points including rate and duration of response, and survival.


Twelve patients were treated. No kidney rejection or loss was observed. A response to cemiplimab was observed in five of 11 evaluable patients (46%; 90% CI, 22 to 73), including two with durable responses beyond a year. Median follow-up was 6.8 months (range, 0.7-29.8). Treatment-related grade 3 or greater 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.


mTOR inhibitor and corticosteroids represent a favorable immunosuppressive regimen for KTRs with advanced CSCC receiving immunotherapy. This combination resulted in durable antitumor responses with no kidney rejection events (funded by Regeneron Pharmaceuticals [ClinicalTrials.gov identifier: NCT04339062]).

Author Affiliations

1Center for Head and Neck Oncology, Dana-Farber Cancer Institute, Boston, MA, 2Center for Cutaneous Oncology, Dana-Farber Cancer Institute, Boston, MA, 3Department of Data Science, Dana-Farber Cancer Institute, Boston, MA, 4Department of Hematology/Oncology, Tufts Medical Center, Boston, MA, 5Department of Hematology/Oncology, Maine Health Cancer Center, Portland, ME, 6Department of Medicine, Renal Division, Massachusetts General Hospital, Boston, MA, 7Belfer Center for Applied Cancer Science, Dana-Farber Cancer Institute, Boston, MA, 8Division of Renal Medicine, Brigham and Women’s Hospital, Boston, MA, 9Division of Renal Medicine, Brigham and Women’s Hospital, Boston, MA, 10Center for Cutaneous Oncology, Dana-Farber Cancer Institute, Boston, MA

Leave a Comment

Your email address will not be published. Required fields are marked *

Related Articles