RF-Cemiplimab: First Drug Approved for the Treatment of Metastatic or Unresectable Cutaneous Squamous Cell Carcinoma

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Morgado-Carrasco, X. Bosch-Amate, X. Fustà-Novell, P. Giavedoni" "autores" => array:4 [ 0 => array:2 [ "nombre" => "D." "apellidos" => "Morgado-Carrasco" ] 1 => array:2 [ "nombre" => "X." "apellidos" => "Bosch-Amate" ] 2 => array:2 [ "nombre" => "X." "apellidos" => "Fustà-Novell" ] 3 => array:4 [ "nombre" => "P." "apellidos" => "Giavedoni" "email" => array:1 [ 0 => "giavedonip@gmail.com" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Servicio de Dermatología, Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona, Spain" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "FR-Cemiplimab, primer fármaco aprobado para el tratamiento del carcinoma cutáneo de células escamosas metastásico o irresecable" ] ] "textoCompleto" => "Treatment of advanced cutaneous squamous cell carcinoma (CSCC) is complex, and no specific drugs have been approved. CSCC carries a high mutational burden and is associated with immunosuppression,<a class="elsevierStyleCrossRef" href="#bib0005">1</a> suggesting that it is a potential target for immunotherapy.The United States Food and Drug Administration (FDA) recently approved cemiplimab, an anti–programmed cell death 1 antibody, for the treatment of metastatic or locally advanced CSCC that cannot be treated with curative radiotherapy or surgery.<a class="elsevierStyleCrossRef" href="#bib0010">2</a> Approval was based on the results of 2 trials: R2810-ONC-1423 (Trial 1), a phase 1 multicenter, open-label, dose-finding clinical trial in patients with a variety of advanced solid tumors<a class="elsevierStyleCrossRef" href="#bib0015">3</a>; and R2810-ONC-1540 (Trial 2), a multicenter phase 2 open-label, nonrandomized, 3-arm clinical trial (2 arms with metastatic CSCC and cemiplimab every 2 or 3 weeks and 1 arm with locally advanced CSCC and cemiplimab every 2 weeks).<a class="elsevierStyleCrossRef" href="#bib0020">4</a>Trial 1 included 26 patients and Trial 2 included 82 patients. Of these 108 patients, 33 had locally advanced CSCC and 75 metastatic CSCC (69% distal and 31% nodal). Mean age was 71 years, 85% of patients were men, 97% were white, 50% had received ≥ 1 systemic cancer therapy, 96% had undergone surgery, and 79% had undergone radiotherapy. No immunocompromised patients were included. All patients received intravenous cemiplimab 3 mg/kg every 2-3 weeks until disease progression, unacceptable toxicity, or a maximum of 48 weeks (Trial 1) or 96 weeks (Trial 2). Tumor response was evaluated every 8 weeks. The main efficacy objectives were the objective response rate (ORR) and duration of response. These objectives were evaluated by an independent review board in line with the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, based on radiological data and digital photography. The intention-to-treat analysis revealed an ORR of 47% (95% CI, 38%-57%) (4% complete response and 44% partial response). The ORR was similar in metastatic CSCC and in locally advanced CSCC (47% and 49%, respectively). The median duration of response had not been reached at the time of the analysis (range, 1.0-15.2 months; ≥ 6 months in 61%). The median time to response was approximately 2 months.<a class="elsevierStyleCrossRef" href="#bib0010">2</a>Migden et al.<a class="elsevierStyleCrossRef" href="#bib0025">5</a> recently published these results in part. The authors included all the patients from Trial 1 (n = 26), although only those with metastatic CSCC and cemiplimab every 2 weeks from Trial 2 (n = 59). The ORR in the intention-to-treat analysis was 50% and 47%, respectively. As for the safety profile, more than 50% experienced adverse effects (AEs). The most frequent were fatigue, rash, and diarrhea. Treatment had to be suspended owing to AEs in 7% of patients. The most common grade 3-4 AEs were cellulitis, sepsis, arterial hypertension, and pneumonia. Immunological AEs were noteworthy (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>). Eleven patients died during the trials; 3 of the deaths were attributed to treatment with cemiplimab.<elsevierMultimedia ident="tbl0005"></elsevierMultimedia>Immunotherapy is revolutionizing the treatment of advanced cutaneous cancer. Cemiplimab is the first drug to be approved for the treatment of advanced CSCC. The many issues that have yet to be resolved include its role in adjuvant and neoadjuvant treatment, its efficacy in immunocompromised patients, long-term safety (including mortality attributed to the drug), and the high cost of therapy. It is essential that dermatologists become familiar with these new agents and their AEs." "pdfFichero" => "main.pdf" "tienePdf" => true "PalabrasClave" => array:1 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1222587" "palabras" => array:5 [ 0 => "Cemiplimab" 1 => "Immunotherapy" 2 => "Skin cancer" 3 => "Squamous cell carcinoma" 4 => "Cutaneous squamous cell carcinoma" ] ] ] ] "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "Please cite this article as: Morgado-Carrasco D, et al. FR-Cemiplimab, primer fármaco aprobado para el tratamiento del carcinoma cutáneo de células escamosas metastásico o irresecable. Actas Dermosifiliogr. 2020;111:161–163." ] ] "multimedia" => array:1 [ 0 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0005" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:3 [ "leyenda" => "Source: Migden et al.<a class="elsevierStyleCrossRef" href="#bib0025">5</a>Abbreviations: CSCC, cutaneous squamous cell carcinoma; PD-1, programmed cell death protein 1." "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Agent \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Target \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Mechanism of Action \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Dose and Route of Administration \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Adverse Effects<a class="elsevierStyleCrossRef" href="#tblfn0005">a</a> \t\t\t\t\t\t\n \t\t\t\t\t\t</th><th class="td" title="\n \t\t\t\t\ttable-head\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t" scope="col" style="border-bottom: 2px solid black">FDA Approval \t\t\t\t\t\t\n \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Cemiplimab(Libtayo, Regeneron Pharmaceuticals) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">PD-1 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Recombinant human IgG4 monoclonal antibody that acts by blocking the interaction between PD-1 and its ligand. Neoplastic cells express the ligand of PD-1 and PD-2, which, on interacting with the PD-1 receptor of the T lymphocytes, inhibit the immune responseThis drug prevents inhibition of T lymphocytes by tumor cells. The immune system is activated, and self-tolerance is diminished \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">350 mg every 3 weeks in intravenous infusion (for 30 min) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Most frequent: asthenia, rash, and diarrhea \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Metastatic or locally advanced CSCC that cannot be treated with curative radiotherapy or surgery (September 2018) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Dermatologic: pruritus, maculopapular rash, xerosis, skin infections \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Gastrointestinal: diarrhea, vomiting, autoimmune colitis \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Hepatic: increased transaminases, autoimmune hepatitis \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Neurologic and musculoskeletal: fatigue, myalgia, peripheral neuropathy, vertigo, aseptic meningitis \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Endocrine-metabolic: hyponatremia, hypokalemia, autoimmune hypopituitarism, autoimmune hypothyroidism, autoimmune hyperthyroidism, hypo- and hyperglycemia \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Renal: increased serum creatinine, autoimmune nephritis \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Cardiovascular: pulmonary thromboembolism, peripheral edema, ventricular arrhythmia \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Respiratory: cough, dyspnea, upper respiratory tract infection, autoimmune pneumonitis, pneumothorax \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Hematologic: anemia, lymphocytopenia \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"> \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab2273251.png" ] ] ] "notaPie" => array:1 [ 0 => array:3 [ "identificador" => "tblfn0005" "etiqueta" => "a" "nota" => "More than 50% of the patients experienced adverse effects, which were severe in more than 30%." ] ] ] "descripcion" => array:1 [ "en" => "New Immunotherapeutic Agents Used in Advanced Cutaneous Cancer." ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:5 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Carcinoma epidermoide cutáneo: definiendo la variante de alto riesgo" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:4 [ 0 => "A. Martorell-Calatayud" 1 => "O. Sanmartín Jimenez" 2 => "J. Cruz Mojarrieta" 3 => "C. Guillén Barona" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:5 [ "tituloSerie" => "Actas Dermo-Sifiliog" "fecha" => "2013" "volumen" => "104" "paginaInicial" => "367" "paginaFinal" => "379" ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib0010" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Approved Drugs - FDA approves cemiplimab-rwlc for metastatic or locally advanced cutaneous squamous cell carcinoma [Internet]. [consultado 11 Oct 2018]. Disponible en: <a target="_blank" href="https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm622251.htm">https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm622251.htm</a>." ] ] ] 2 => array:3 [ "identificador" => "bib0015" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies - Full Text View - ClinicalTrials.gov [Internet] [consultado 12 Oct 2018]. Disponible en: <a target="_blank" href="https://clinicaltrials.gov/ct2/show/NCT02383212">https://clinicaltrials.gov/ct2/show/NCT02383212</a>." ] ] ] 3 => array:3 [ "identificador" => "bib0020" "etiqueta" => "4" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma - Full Text View - ClinicalTrials.gov [Internet] [consultado 12 Oct 2018]. Disponible en: <a target="_blank" href="https://clinicaltrials.gov/ct2/show/NCT02760498">https://clinicaltrials.gov/ct2/show/NCT02760498</a>." ] ] ] 4 => array:3 [ "identificador" => "bib0025" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "PD-1 Blockade with cemiplimab in advanced cutaneous squamous-cell carcinoma" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "M.R. Migden" 1 => "D. Rischin" 2 => "C.D. Schmults" 3 => "A. Guminski" 4 => "A. Hauschild" 5 => "K.D. Lewis" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1056/NEJMoa1805131" "Revista" => array:6 [ "tituloSerie" => "N Engl J Med" "fecha" => "2018" "volumen" => "379" "paginaInicial" => "341" "paginaFinal" => "351" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/29863979" "web" => "Medline" ] ] ] ] ] ] ] ] ] ] ] ] ] "idiomaDefecto" => "en" "url" => "/15782190/0000011100000002/v1_202004140647/S1578219020300123/v1_202004140647/en/main.assets" "Apartado" => array:4 [ "identificador" => "34945" "tipo" => "SECCION" "en" => array:2 [ "titulo" => "Resident's Forum" "idiomaDefecto" => true ] "idiomaDefecto" => "en" ] "PDF" => "https://static.elsevier.es/multimedia/15782190/0000011100000002/v1_202004140647/S1578219020300123/v1_202004140647/en/main.pdf?idApp=UINPBA000044&text.app=https://actasdermo.org/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S1578219020300123?idApp=UINPBA000044"]

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RF-Cemiplimab: First Drug Approved for the Treatment of Metastatic or Unresectable Cutaneous Squamous Cell Carcinoma

FR-Cemiplimab, primer fármaco aprobado para el tratamiento del carcinoma cutáneo de células escamosas metastásico o irresecable

D. Morgado-Carrasco, X. Bosch-Amate, X. Fustà-Novell, P. Giavedoni

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giavedonip@gmail.com

Corresponding author.

Servicio de Dermatología, Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona, Spain

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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Treatment of advanced cutaneous squamous cell carcinoma &#40;CSCC&#41; is complex&#44; and no specific drugs have been approved&#46; CSCC carries a high mutational burden and is associated with immunosuppression&#44;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> suggesting that it is a potential target for immunotherapy&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">The United States Food and Drug Administration &#40;FDA&#41; recently approved cemiplimab&#44; an anti&#8211;programmed cell death 1 antibody&#44; for the treatment of metastatic or locally advanced CSCC that cannot be treated with curative radiotherapy or surgery&#46;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> Approval was based on the results of 2 trials&#58; R2810-ONC-1423 &#40;Trial 1&#41;&#44; a phase 1 multicenter&#44; open-label&#44; dose-finding clinical trial in patients with a variety of advanced solid tumors<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a>&#59; and R2810-ONC-1540 &#40;Trial 2&#41;&#44; a multicenter phase 2 open-label&#44; nonrandomized&#44; 3-arm clinical trial &#40;2 arms with metastatic CSCC and cemiplimab every 2 or 3 weeks and 1 arm with locally advanced CSCC and cemiplimab every 2 weeks&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Trial 1 included 26 patients and Trial 2 included 82 patients&#46; Of these 108 patients&#44; 33 had locally advanced CSCC and 75 metastatic CSCC &#40;69&#37; distal and 31&#37; nodal&#41;&#46; Mean age was 71 years&#44; 85&#37; of patients were men&#44; 97&#37; were white&#44; 50&#37; had received&#8239;&#8805;&#8239;1 systemic cancer therapy&#44; 96&#37; had undergone surgery&#44; and 79&#37; had undergone radiotherapy&#46; No immunocompromised patients were included&#46; All patients received intravenous cemiplimab 3&#8239;mg&#47;kg every 2-3 weeks until disease progression&#44; unacceptable toxicity&#44; or a maximum of 48 weeks &#40;Trial 1&#41; or 96 weeks &#40;Trial 2&#41;&#46; Tumor response was evaluated every 8 weeks&#46; The main efficacy objectives were the objective response rate &#40;ORR&#41; and duration of response&#46; These objectives were evaluated by an independent review board in line with the Response Evaluation Criteria in Solid Tumors &#40;RECIST&#41;&#44; version 1&#46;1&#44; based on radiological data and digital photography&#46; The intention-to-treat analysis revealed an ORR of 47&#37; &#40;95&#37;&#8239;CI&#44; 38&#37;-57&#37;&#41; &#40;4&#37; complete response and 44&#37; partial response&#41;&#46; The ORR was similar in metastatic CSCC and in locally advanced CSCC &#40;47&#37; and 49&#37;&#44; respectively&#41;&#46; The median duration of response had not been reached at the time of the analysis &#40;range&#44; 1&#46;0-15&#46;2 months&#59; &#8805;&#8239;6 months in 61&#37;&#41;&#46; The median time to response was approximately 2 months&#46;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">Migden et al&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> recently published these results in part&#46; The authors included all the patients from Trial 1 &#40;n&#8239;&#61;&#8239;26&#41;&#44; although only those with metastatic CSCC and cemiplimab every 2 weeks from Trial 2 &#40;n&#8239;&#61;&#8239;59&#41;&#46; The ORR in the intention-to-treat analysis was 50&#37; and 47&#37;&#44; respectively&#46; As for the safety profile&#44; more than 50&#37; experienced adverse effects &#40;AEs&#41;&#46; The most frequent were fatigue&#44; rash&#44; and diarrhea&#46; Treatment had to be suspended owing to AEs in 7&#37; of patients&#46; The most common grade 3-4 AEs were cellulitis&#44; sepsis&#44; arterial hypertension&#44; and pneumonia&#46; Immunological AEs were noteworthy &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46; Eleven patients died during the trials&#59; 3 of the deaths were attributed to treatment with cemiplimab&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0025" class="elsevierStylePara elsevierViewall">Immunotherapy is revolutionizing the treatment of advanced cutaneous cancer&#46; Cemiplimab is the first drug to be approved for the treatment of advanced CSCC&#46; The many issues that have yet to be resolved include its role in adjuvant and neoadjuvant treatment&#44; its efficacy in immunocompromised patients&#44; long-term safety &#40;including mortality attributed to the drug&#41;&#44; and the high cost of therapy&#46; It is essential that dermatologists become familiar with these new agents and their AEs&#46;</p></span>"
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t"><span class="elsevierStyleItalic">Dermatologic&#58;</span> pruritus&#44; maculopapular rash&#44; xerosis&#44; skin infections&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t"><span class="elsevierStyleItalic">Gastrointestinal&#58;</span> diarrhea&#44; vomiting&#44; autoimmune colitis&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t"><span class="elsevierStyleItalic">Hepatic&#58;</span> increased transaminases&#44; autoimmune hepatitis&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">Neurologic and musculoskeletal&#58;</span> fatigue&#44; myalgia&#44; peripheral neuropathy&#44; vertigo&#44; aseptic meningitis&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t"><span class="elsevierStyleItalic">Renal&#58;</span> increased serum creatinine&#44; autoimmune nephritis&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleItalic">Cardiovascular&#58;</span> pulmonary thromboembolism&#44; peripheral edema&#44; ventricular arrhythmia&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t"><span class="elsevierStyleItalic">Respiratory&#58;</span> cough&#44; dyspnea&#44; upper respiratory tract infection&#44; autoimmune pneumonitis&#44; pneumothorax&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t"><span class="elsevierStyleItalic">Hematologic&#58;</span> anemia&#44; lymphocytopenia&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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Article information

ISSN: 15782190
Original language: English

DOI:10.1016/j.adengl.2018.10.026

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2024 October	62	53	115
2024 September	89	40	129
2024 August	89	71	160
2024 July	65	40	105
2024 June	61	53	114
2024 May	55	38	93
2024 April	62	26	88
2024 March	63	35	98
2024 February	54	40	94
2024 January	46	36	82
2023 December	57	17	74
2023 November	61	49	110
2023 October	47	24	71
2023 September	38	30	68
2023 August	26	23	49
2023 July	29	36	65
2023 June	25	26	51
2023 May	34	30	64
2023 April	21	24	45
2023 March	47	36	83
2023 February	40	26	66
2023 January	43	36	79
2022 December	46	41	87
2022 November	42	33	75
2022 October	32	34	66
2022 September	51	33	84
2022 August	43	40	83
2022 July	34	58	92
2022 June	36	33	69
2022 May	42	52	94
2022 April	43	33	76
2022 March	44	58	102
2022 February	36	31	67
2022 January	40	37	77
2021 December	34	40	74
2021 November	47	37	84
2021 October	68	67	135
2021 September	41	47	88
2021 August	46	27	73
2021 July	22	17	39
2021 June	33	27	60
2021 May	59	40	99
2021 April	117	108	225
2021 March	53	29	82
2021 February	57	28	85
2021 January	40	24	64
2020 December	25	15	40
2020 November	23	17	40
2020 October	28	23	51
2020 September	51	17	68
2020 August	38	18	56
2020 July	29	27	56
2020 June	36	21	57
2020 May	42	20	62
2020 April	63	21	84
2020 March	30	16	46
2020 February	5	6	11

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