Regeneron Pharmaceuticals and Sanofi have secured approval from the US Food and Drug Administration (FDA) for their Libtayo (cemiplimab-rwlc) to treat patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
Libtayo is a fully-human monoclonal antibody that targets the immune checkpoint receptor PD-1 (programmed cell death protein-1), and is claimed to be the first and only treatment specifically approved for advanced CSCC in the US.
Regeneron translational science and clinical oncology head and global clinical development vice president Dr Israel Lowy said: “We are proud to offer patients in the U.S. this first and only treatment for advanced CSCC and remain focused on advancing our clinical research investigating Libtayo as a potential monotherapy and combination therapy in other cancer types.”
The approval was based on a combined analysis of data from an open-label, multi-center, non-randomized phase 2 trial called Empower-CSCC-1 and two advanced CSCC expansion cohorts from a multi-center, open-label and non-randomized phase 1 trial.
According to the company, the major efficacy outcome measures for the integrated analysis of Empower-CSCC-1 and the two CSCC expansion cohorts have been confirmed objective response rate (ORR), as assessed by independent central review (ICR), and ICR-assessed duration of response (DOR).
In 2017, Libtayo secured breakthrough therapy designation from the FDA to treat advanced CSCC.
Regeneron, along with Sanofi’s specialty care global business unit Sanofi Genzyme, will commercialize Libtayo in the US.
Regeneron was invented Libtayo by using its advanced VelocImmune technology, which generates optimized fully-human antibodies.
In April this year, the European Medicines Agency (EMA) approved marketing authorization application for review of Libtayo to treat patients with metastatic CSCC or with locally advanced CSCC who are not candidates for surgery.
The EMA review process is expected to be completed in the first half of this year, while there are currently no EMA-approved treatments for advanced CSCC.
The cemiplimab-rwlc is also being studied in trials in non-small cell lung cancer, basal cell carcinoma, and cervical cancer along with trials in squamous cell carcinoma of the head and neck, melanoma, colorectal cancer, prostate cancer, multiple myeloma.
Sanofi CEO Dr Olivier Brandicourt said: “We believe Libtayo has the potential to make a difference for U.S. patients with advanced CSCC, as it helps to fill a critical gap in treatment options. We are committed to bringing this important medicine to patients in other countries around the world as quickly as possible.”