All patients received LIBTAYO as an IV infusion over 30 minutes until unequivocal progression of disease, unacceptable toxicity or completion of planned treatment.‡
Primary endpoint: ORR †
Key secondary endpoint: DOR
Other secondary endpoints: PFS, OS, CRR
and EORTC QLQ-C30
laCSCC: locally advanced CSCC; mCSCC: metastatic CSCC; ORR:
objective response rate; DOR: duration of response; PFS: progression
free survival; OS: overall survival; CRR: complete response rate;
EORTC QLQ-C30: European Organization for Research and Treatment of
Cancer quality of life questionnaire 30.
† ORR was assessed by independent central review. For patients with
metastatic CSCC without externally visible target lesions, ORR was
determined by Response Evaluation Criteria in Solid Tumors (RECIST
1.1). For patients with externally visible target lesions (locally
advanced CSCC and metastatic CSCC), ORR was determined by a
composite endpoint that integrated ICR assessments of radiologic
data (RECIST 1.1) and digital medical photography (WHO
criteria).1
‡ Patients could continue treatment beyond initial progression at
the discretion of the investigator. If patients with locally
advanced disease showed sufficient response to treatment, surgery
with curative intent was permitted. 1
Learn about the safety and tolerability profile of LIBTAYO in patients with advanced CSCC.
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Explore the efficacy profile of LIBTAYO, including cases seen from the trials.
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