The US FDA has approved Libtayo® (cemiplimab-rwlc), the first and only treatment specifically approved and available for advanced cutaneous squamous cell carcinoma (CSCC) in the USA.
CSCC is the second most common form of skin cancer and is responsible for an estimated 7000 deaths each year in the USA. It currently accounts for approximately 20% of all skin cancers in the USA, with the number of newly diagnosed cases expected to rise annually. Libtayo is the third anti-PD-1 approved in the USA.
“We’re continuing to see a shift in oncology toward identifying and developing drugs aimed at a specific molecular target. With the Libtayo approval, the FDA has approved six immune checkpoint inhibitors targeting the PD-1 / PD-L1 pathway for treating a variety of tumors, from bladder to head and neck cancer, and now advanced CSCC,” explained Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
The approval of Libtayo is based on a combined analysis of data from an open-label, multi-center, non-randomized Phase II trial known as EMPOWER-CSCC-1 (Study 1540) and two advanced CSCC expansion cohorts from a multi-center, open-label, non-randomized Phase I trial (Study 1423). Together, the trials represent the largest prospective data set in advanced CSCC.
A total of 108 patients (75 with metastatic disease and 33 with locally-advanced disease) were included in the efficacy evaluation. The study’s primary endpoint was objective response rate; results demonstrated that 47.2% of all patients treated with Libtayo had their tumors shrink or disappear. The majority of these patients had ongoing responses at the time of data analysis.
The recommended dosage of Libtayo is 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks, until disease progression or unacceptable toxicity; it is available as a single-dose 350 mg vial.
“Libtayo is an important new immunotherapy option for U.S. physicians to help address a significant unmet need in this patient group,” added lead investigator in the pivotal CSCC clinical program Michael R Migden from The University of Texas MD Anderson Cancer Center (TX, USA).