Libtayo Approved in Europe to Treat Metastatic or Advanced Cutaneous Squamous Cell Carcinoma

Libtayo (cemiplimab) has been conditionally approved to be sold in the European Union for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC), one of the most common types of skin cancer.

The decision of the European Commission (EC) makes Libtayo the only treatment available in Europe for adult patients with advanced CSCC who are not eligible to undergo surgery or radiation therapy.

Libtayo is an engineered human antibody designed to target the immune checkpoint receptor PD-1 and enhance the immune system’s anti-cancer activity. It resulted from the collaboration between Regeneron Pharmaceuticals and Sanofi.

This immunotherapy was approved by the U.S. Food and Drug Administration in September 2018, and is also available to treat patient with CSCC in Canada and Brazil.

“With no other medical treatments approved for advanced CSCC in the EU, Libtayo represents an important new option for patients affected with this advanced skin cancer who cannot be cured by surgery or radiation,” Axel Hauschild, MD, PhD, an investigator in the pivotal CSCC clinical program, and professor and head of the Interdisciplinary Skin Cancer Center at the University Hospital Schleswig-Holstein in Kiel, Germany, said in a press release.

The EC’s decision was supported by clinical data from the pivotal, open-label, multi-center, non-randomized Phase 2 trial (EMPOWER-CSCC-1, NCT02760498), as well as from two advanced CSCC expansion groups from a multi-center, open-label, non-randomized Phase 1 trial (NCT02383212).

With the largest group of CSCC patients to take part in a clinical trial for a systemic therapy, EMPOWER-CSCC-1 has demonstrated that Libtayo can prevent cancer spread and progression.

After a follow up period of up to 28 months, the treatment had reduced tumor volume in 46% of the 137 CSCC patients, with 14.7% of patients experiencing complete tumor clearance, and 31.4% experiencing partial tumor shrinkage.

Overall response rates to treatment were 49% for metastatic and 44% for locally advanced CSCC.

To date, the most common adverse events reported were fatigue, diarrhea, and nausea, with serious adverse effects occurring in 24% of patients.

The latest clinical data from EMPOWER-CSCC-1 trial were discussed in several poster presentations at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

“Results from the Libtayo pivotal trial are very encouraging and demonstrated substantial and durable responses following Libtayo treatment, including in the elderly and regardless of PD-L1 expression levels,” said Hauschild.

As part of the EC’s conditional approval, Regeneron and Sanofi will add a new patient group to EMPOWER-CSCC-1 to further explore and demonstrate the benefit-risk profile of Libtayo in CSCC. As a standard procedure with such approvals, the European Medicines Agency will review all new clinical data and update Libtayo’s labeling as necessary.

The recommended dose of Libtayo is 350 mg every three weeks administered by intravenous infusion over 30 minutes. Treatment may be continued until disease progression or unacceptable toxicity.

The safety and anti-cancer activity of Libtayo is currently being explored in several clinical trials as an add-on therapy for non-small cell lung cancer, basal cell carcinoma, and cervical cancer. Also, its potential when used alone or in combination is also being assessed for the treatment of several blood and solid cancers, including colorectal cancer, prostate cancer, multiple myeloma, Hodgkin’s lymphoma, and non-Hodgkin’s lymphoma.

More information about ongoing Libtayo trials, their recruitment status, and their locations can be found here.