TY - JOUR
T1 - Cemiplimab for Kidney Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma
AU - Hanna, Glenn J.
AU - Dharanesswaran, Harita
AU - Giobbie-Hurder, Anita
AU - Harran, John J.
AU - Liao, Zixi
AU - Pai, Lori
AU - Tchekmedyian, Vatche
AU - Ruiz, Emily S.
AU - Waldman, Abigail H.
AU - Schmults, Chrysalyne D.
AU - Riella, Leonardo V.
AU - Lizotte, Patrick
AU - Paweletz, Cloud P.
AU - Chandraker, Anil K.
AU - Murakami, Naoka
AU - Silk, Ann W.
N1 - Publisher Copyright:
© 2024 American Society of Clinical Oncology.
PY - 2024/3/20
Y1 - 2024/3/20
N2 - PURPOSECemiplimab 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.METHODSWe 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.RESULTSTwelve 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.CONCLUSIONmTOR 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]).
AB - PURPOSECemiplimab 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.METHODSWe 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.RESULTSTwelve 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.CONCLUSIONmTOR 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]).
UR - http://www.scopus.com/inward/record.url?scp=85188030820&partnerID=8YFLogxK
U2 - 10.1200/JCO.23.01498
DO - 10.1200/JCO.23.01498
M3 - Article
C2 - 38252908
AN - SCOPUS:85188030820
SN - 0732-183X
VL - 42
SP - 1021
EP - 1030
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 9
ER -