1061P Safety of cemiplimab for advanced cutaneous squamous cell carcinoma: The Spanish named patient programme

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 Cemiplimab was withdrawn due to TREAEs in only 5 (3.6%) patients.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.