ABSTRACT
Background: Cemiplimab is a programmed cell death receptor-1 inhibitor with antitumour activity for cutaneous squamous cell carcinoma (CSCC) and acceptable safety proved in its pivotal trial. We provide the first data on cemiplimab safety in daily practice from the named patient programme (NPP) for advanced CSCC in Spain. Methods: This cemiplimab NPP was performed from March 2019 to March 2020. It included patients aged ≥18 years with advanced CSCC and ineligible for surgery, radiation therapy or clinical trials. The cemiplimab safety was assessed according to treatment-emergent adverse events (TEAEs) reported until March 2021. Results: 140 patients were included (median age [interquartile range, IQR] 77.0 [65.0-84.0] years;age ≥80 38%;men 71.7%;≥1 comorbidity 83%;ECOG 0-1 86.3%;locally advanced CSCC 60.7%;cemiplimab as first-line therapy 67.7%). Cemiplimab was received for a median (IQR) of 8.0 (3.0-14.0) cycles. Fifty-eight (41.4%) patients showed ≥1 of the 163 TEAEs reported, which most frequently included diarrhoea n=7, asthenia n=6, constipation n=4 and abdominal pain n=4. Fourteen (8.6%) were immune-mediated, mainly bronchitis n=2, pneumonitis n=2 and hepatitis n=2. Seventy-eight (47.9%) TEAEs were grade ≥3, most frequently pneumonia n=3, COVID-19 n=3, general physical health deterioration n=2, pyrexia n=2, renal transplant failure n=2, sepsis n=2, acute kidney injury n=2 and respiratory failure n=2. Twenty-one (12.9%) were treatment-related (TREAEs): 11 (6.7%) were grade 1-2 (diarrhoea n=3 and asthenia, hepatotoxicity, malnutrition, odynophagia, polymyalgia rheumatica, pneumonitis, pruritus, and skin toxicity), 9 (5.5%) grade 3 (acute kidney injury, adrenal insufficiency, abdominal pain, blood creatinine increased, dysphagia, haematuria, immune-mediated enterocolitis, panniculitis, surgical wound infection) and 1 (0.6%) unknown grade. Cemiplimab was withdrawn due to TREAEs in only 5 (3.6%) patients. The TEAE outcome was fatal in 29 (17.8%);none related to cemiplimab. Conclusions: This NPP supports the real-life safety of cemiplimab for CSCC, showing an acceptable safety profile consistent with previous reports. Editorial acknowledgement: Editorial assistance was provided by Esther Álvarez-García at Dynamic Science S.L., funded by Sanofi. Legal entity responsible for the study: Sanofi. Funding: Sanofi. Disclosure: E. Muñoz Couselo: Financial Interests, Personal, Advisory Board: Amgen;Financial Interests, Personal, Advisory Board: Bristol-Myers Squibb;Financial Interests, Personal, Advisory Board: Merck Sharp & Dohme;Financial Interests, Personal, Advisory Board: Novartis;Financial Interests, Personal, Advisory Board: Pierre Fabre;Financial Interests, Personal, Advisory Board: Roche;Financial Interests, Personal, Advisory Board: Sanofi;Financial Interests, Personal, Other, Honoraria: Amgen;Financial Interests, Personal, Other, Honoraria: Bristol-Myers Squibb;Financial Interests, Personal, Other, Honoraria: Merck Sharp & Dohme;Financial Interests, Personal, Other, Honoraria: Novartis;Financial Interests, Personal, Other, Honoraria: Pierre Fabre;Financial Interests, Personal, Other, Honoraria: Roche;Financial Interests, Personal, Principal Investigator: Amgen;Financial Interests, Personal, Principal Investigator: Bristol-Myers Squibb;Financial Interests, Personal, Principal Investigator: GlaxoSmithKline;Financial Interests, Personal, Principal Investigator: Merck Sharp & Dohme;Financial Interests, Personal, Principal Investigator: Novartis;Financial Interests, Personal, Principal Investigator: Pierre Fabre;Financial Interests, Personal, Principal Investigator: Roche;Financial Interests, Personal, Principal Investigator: Sanofi. A. Soria: Financial Interests, Personal, Invited Speaker: Novartis;Financial Interests, Personal, Invited Speaker: Sanofi Aventis;Financial Interests, Personal, Invited Speaker: Roche Pharma;Financial Interests, Personal, Invited Speaker: Merck Serono;Financial Interests, Personal, Invited Speaker: Merck Sharp & Dohme;Financial Interests, Perso al, Invited Speaker: Bristol-Myers Squibb;Financial Interests, Personal, Invited Speaker: Pierre Fabre;Financial Interests, Personal, Advisory Board: Novartis;Financial Interests, Personal, Advisory Board: Sanofi Aventis;Financial Interests, Personal, Advisory Board: Roche Pharma;Financial Interests, Personal, Advisory Board: Merck Serono;Financial Interests, Personal, Advisory Board: Merck Sharp & Dohme;Financial Interests, Personal, Advisory Board: Bristol-Myers Squibb;Financial Interests, Personal, Advisory Board: Pierre Fabre;Financial Interests, Personal, Principal Investigator: Novartis;Financial Interests, Personal, Principal Investigator: Sanofi Aventis;Financial Interests, Personal, Principal Investigator: Roche Pharma;Financial Interests, Personal, Principal Investigator: Merck Serono;Financial Interests, Personal, Principal Investigator: Merck Sharp & Dohme;Financial Interests, Personal, Principal Investigator: Bristol-Myers Squibb;Financial Interests, Personal, Principal Investigator: Pierre Fabre. O. Sanmartin: Financial Interests, Personal, Invited Speaker: Sanofi Genzyme;Financial Interests, Personal, Advisory Board: Sanofi Genzyme;Financial Interests, Personal, Officer: Sanofi Genzyme;Financial Interests, Personal, Principal Investigator: Sanofi Genzyme;Financial Interests, Personal, Invited Speaker: Roche Pharma;Financial Interests, Personal, Advisory Board: Roche Pharma;Financial Interests, Personal, Officer: Roche Pharma;Financial Interests, Personal, Principal Investigator: Roche Pharma. J. Cañueto: Financial Interests, Personal, Invited Speaker: Hoffman-La Roche;Financial Interests, Personal, Invited Speaker: Sanofi-Genzyme;Financial Interests, Personal, Invited Speaker: AbbVie;Financial Interests, Personal, Invited Speaker: LeoPharma;Financial Interests, Personal, Other, Consultancy: Sanofi-Genzyme;Financial Interests, Personal, Other, Consultancy: InflaRx;Financial Interests, Personal, Other, Consultancy: Almirall. S. Beá Ardébol: Financial Interests, Personal, Invited Speaker: Meda;Financial Interests, Personal, Advisory Board: Sanofi;Financial Interests, Personal, Advisory Board: SunPharma;Financial Interests, Personal, Other, Trial subinvestigator: Sanofi Aventis;Financial Interests, Personal, Other, Trial subinvestigator: SunPharma;Financial Interests, Personal, Other, Trial subinvestigator: PellePharma. R. Fernández-de-Misa Cabrera: Financial Interests, Personal, Advisory Board: Sanofi. A.J. Cunquero-Tomás: Financial Interests, Personal, Invited Speaker: BMS;Financial Interests, Personal, Invited Speaker: Pierre-Fabre;Financial Interests, Personal, Writing Engagements: Sanofi;Financial Interests, Personal, Other, 2021 EADO/WMC Congress inscription fee: Sanofi. L. Fernández Franco: Non-Financial Interests, Personal, Invited Speaker: Merck;Non-Financial Interests, Personal, Invited Speaker: Sanofi;Non-Financial Interests, Personal, Invited Speaker: Servier. I. Romero: Financial Interests, Personal, Invited Speaker: Pharmamar;Financial Interests, Personal, Invited Speaker: Roche;Financial Interests, Personal, Invited Speaker: GSK;Financial Interests, Personal, Invited Speaker: Clovis;Financial Interests, Personal, Invited Speaker: AstraZeneca;Financial Interests, Personal, Advisory Board: Pharmamar;Financial Interests, Personal, Advisory Board: Roche;Financial Interests, Personal, Advisory Board: GSK;Financial Interests, Personal, Advisory Board: Clovis;Financial Interests, Personal, Advisory Board: AstraZeneca. J. Medina Martínez: Non-Financial Interests, Personal, Invited Speaker: Roche;Non-Financial Interests, Personal, Speaker’s Bureau: Roche;Non-Financial Interests, Personal, Advisory Board: Roche;Non-Financial Interests, Personal, Invited Speaker: Novartis;Non-Financial Interests, Personal, Speaker’s Bureau: Novartis;Non-Financial Interests, Personal, Advisory Board: Novartis;Non-Financial Interests, Personal, Invited Speaker: BMS;Non-Financial Interests, Personal, Speaker’s Bureau: BMS;Non-Financial Interests, Personal, Ad isory Board: BMS;Non-Financial Interests, Personal, Invited Speaker: MSD;Non-Financial Interests, Personal, Speaker’s Bureau: MSD;Non-Financial Interests, Personal, Invited Speaker: Pierre Fabre;Non-Financial Interests, Personal, Speaker’s Bureau: Pierre Fabre;Non-Financial Interests, Personal, Advisory Board: Pierre Fabre;Non-Financial Interests, Personal, Invited Speaker: Merk;Non-Financial Interests, Personal, Speaker’s Bureau: Merk;Non-Financial Interests, Personal, Invited Speaker: Sanofi;Non-Financial Interests, Personal, Speaker’s Bureau: Sanofi;Non-Financial Interests, Personal, Advisory Board: Sanofi;Non-Financial Interests, Personal, Invited Speaker: Servier. All other authors have declared no conflicts of interest.