Sanofi and Regeneron’s Libtayo (Cemiplimab) Receives Approval as First Immune Therapy for Advanced Basal Cell Carcinoma

October 31, 2021 /BioonBIOON/ -- Sanofi recently announced that the therapy developed in partnership with RegeneronAnti-PD-1 therapy Libtayo (cemiplimab)Approved by Health Canada,As monotherapy, for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (BCC) who have previously been treated with a hedgehog pathway inhibitor (HHI) but have experienced disease progression or are intolerant to this class of agents.

In the United States and the European Union, Libtayo was approved for the aforementioned indication in February 2021 and June 2021, respectively. Patients with BCC have had almost no options beyond surgery and very limited treatment alternatives. The approval of this new indication for Libtayo marks a significant advancement in the treatment of advanced BCC, bringing new hope to patients.

To date,Libtayo has been approved for the treatment of three advanced cancers: BCC, non-small cell lung cancer (NSCLC), and cutaneous squamous cell carcinoma (CSCC).。CSCC and BCC are the two most common types of skin cancer,Libtayo is the first drug approved for the treatment of advanced CSCC and the first immunotherapy approved for the treatment of advanced BCC.

Basal cell carcinoma (BCC) is the most common type of skin cancer worldwide. Although the vast majority of BCCs are detected at an early stage and can be easily cured with surgery and radiation therapy, a small subsetTumorIt may progress to an advanced stage and invade surrounding tissues (locally advanced), which is more difficult to treat.

The regulatory approval of Libtayo for the treatment of locally advanced or metastatic BCC, based on data from a Phase II clinical trial (NCT03132636), represents the largest prospective study to date conducted in these patients.Clinical Trialthe results. Data show: (1)In patients with metastatic BCC (mBCC), with a median follow-up of 9.5 months, the overall response rate (ORR) was 21%., median duration of response (DOR) not reached (9-23+), DOR ≥6 months in all patients; (2)In the locally advanced BCC (laBCC) cohort, with a median follow-up of 15.1 months, the ORR was 31%,Median DOR has not been reached; an estimated 85% of responding patients had a DOR ≥ 1 year, with a 1-year progression-free survival rate of 57% and a 1-year overall survival rate of 92%.

Libtayo belongs to the anti-PD-(L)1 inhibitor class, a category of cancer immunotherapy that has currently garnered significant attention. It aims to harness the body's own immune system to combat cancer by blocking the PD-1/PD-L1 signaling pathway to induce cancer cell death, and demonstrates therapeutic efficacy for multiple typesTumorpotential. Libtayo is a fully human monoclonal antibody that targets the immune checkpoint receptor PD-1 on T cells. By binding to PD-1, Libtayo has been shown to prevent cancer cells from suppressing T cell activation via the PD-1 pathway.

Libtayo was created and optimized using Regeneron's proprietary Velocimmune technology platform, and is currently being co-developed under a global collaboration agreement between Regeneron and Sanofi for the treatment of various types of cancer. Libtayo's extensive clinical program focuses on refractory cancers, including skin cancer, cervical cancer, solid tumors, and hematologic malignancies. (Bioon.com)

Source:Libtayo (cemiplimab) approved in Canada for locally advanced basal cell carcinoma (BCC) patients