Study 1423 and Study 1540 – Two prospective, open-label clinical trials
evaluating the efficacy and safety of LIBTAYO1

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

SAFETY PROFILE

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EFFICACY PROFILE

Explore the efficacy profile of LIBTAYO, including cases seen from the trials.

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