Overlegen nr. 1 - 2021

EMPOWER-CSCC-1 study design LIBTAYO ® has been studied in a prospective trial in patients with advanced CSCC 1-3 In an open-label, multi-senter, phase 2 study, 193 patients with metastatic (nodal or distant) CSCC (mCSCC) or locally advanced CSCC (laCSCC) who were not candidates for curative surgery or curative radiation have been randomized to three groups 1,2 Primary endpoint: • Confirmed ORR by independent central review Secondary endpoints included: • Duration of response • ORR by investigator assessment • Progression-free survival • Overall survival • Complete response rate GODKJENT av Beslutningsforum! 6 Som monoterapi er LIBTAYO ® indisert til behandling av voksne pasienter med metastatisk eller lokalavansert kutant plateepitelkarsinom, som ikke er egnet for kurativ kirurgi eller kurativ strålebehandling 1,2 Tumor response assessment every 8 weeks Tumor response assessment every 9 weeks Group 1 Patients with metastatic (nodal or distant) CSCC (n = 59) mCSCC mCSCC Group 3 Patients with metastatic (nodal or distant) CSCC (n = 56) laCSCC Group 2 Patients with locally advanced CSCC who were not candidates for curative surgery or curative radiation (n = 78) LIBTAYO ® 3 mg/kg Q2W for up to 96 weeks a LIBTAYO ® 350 mg Q3W for up to 54 weeks Graphically adapted by Sanofi Genzyme PD-L1 testing er ikke nødvendig 4 HOLD DEG OPPDATERT!: HTTPS://WWW.SANOFI.NO/ NO/CONTACT-HCP