FDA Approves Libtayo® (Cemiplimab-rwlc) as First Immunotherapy for Advanced Basal Cell Carcinoma

February 13, 2021 News /BioValleyBIOON/ -- Sanofi and its partner Regeneron recently jointly announced that the U.S. Food and Drug Administration (FDA) has approved the anti-PD-1 therapy Libtayo (cemiplimab) for the treatment of patients with advanced basal cell carcinoma (BCC) who have previously been treated with a hedgehog pathway inhibitor (HHI) or are not candidates for such therapy. Notably, Libtayo is the first immunotherapy approved for the treatment of BCC, with full approval for locally advanced BCC and accelerated approval for metastatic BCC.

Currently, Libtayo is approved in the United States for the treatment of patients with advanced stages of the two most common types of skin cancer. In September 2018, Libtayo received U.S.FDAApproved as the first drug approved for the treatment of advanced cutaneous squamous cell carcinoma (CSCC). The specific indications are: for the treatment of patients with metastatic CSCC, and for the treatment of patients with locally advanced CSCC who are not candidates for curative surgery or curative radiation therapy.

BCC is the most common type of skin cancer worldwide, with approximately 2 million new cases diagnosed annually in the United States alone. Although the vast majority of BCCs are detected at an early stage and can be easily cured through surgery and radiation therapy, a small subsetTumorIt can progress to an advanced stage and infiltrate surrounding tissues (locally advanced), making it more difficult to treat. In the United States, approximately 20,000 patients have advanced BCC, with about 3,000 deaths annually.

Libtayo for the Treatment of BCCClinical Trialsaid Dr. Karl Lewis, Chief Investigator and Professor of Medical Oncology at the University of Colorado, “TodayFDAThe approval of Libtayo will change the treatment paradigm for patients with advanced basal cell carcinoma (BCC). Advanced BCC is a persistent, painful, and highly disfiguring cancer. Although the primary systemic treatment option is hedgehog inhibitor (HHI) therapy, many patients eventually experience disease progression or become intolerant to this treatment. Libtayo has been demonstrated to have clinically meaningful and durable anti-Tumorresponse, this approval will provide these patients with a new immunotherapy option.”

The approval of this indication for BCC is based on the results of an open-label, multicenter, non-randomized Phase II clinical trial. The trial was conducted in patients with unresectable locally advanced BCC or metastatic BCC (nodal or distant) who experienced disease progression during treatment with hedgehog pathway inhibitors (HHIs) or were intolerant to such agents. This is the largest prospective study conducted in this patient population.Clinical Trial(n=132), 112 patients were included in the efficacy analysis. Patients in both cohorts either experienced disease progression during HHI treatment, failed to achieve an objective response after 9 months of HHI treatment, or were intolerant to HHI therapy. The primary efficacy endpoint was the objective response rate (ORR), and the key secondary endpoint was the duration of response (DOR), as assessed by independent central review.

The results demonstrated that treatment with Libtayo (350 mg every 3 weeks) yielded clinically meaningful and durable responses: (1) In the metastatic basal cell carcinoma (mBCC) cohort, with a median follow-up of 9.5 months, the objective response rate (ORR) was 21% (n=6/28, all partial responses [PR]); the median duration of response (DOR) was not reached (range: 9–23+ months), and all six responding patients had a DOR ≥6 months. (2) In the locally advanced basal cell carcinoma (laBCC) cohort, with a median follow-up of 15.1 months, the ORR was 29% (n=24/84), the complete response (CR) rate was 6% (n=5/84), and the partial response (PR) rate was 29% (n=24/84); the median DOR was not reached (range: 2–21+ months), and 79% (n=19) of responding patients had a DOR ≥6 months.

In September 2020, in EuropeTumorLatest data presented at the European Society for Medical Oncology (ESMO) Annual Meeting showed that in the locally advanced basal cell carcinoma (laBCC) cohort, with longer follow-up, the objective response rate (ORR) increased to 31% (n=26/84; 6 complete responses [CR] and 21 partial responses [PR]). Among patients who achieved a response, an estimated 85% had a duration of response (DOR) of ≥1 year.

Among patients evaluable for safety (n=132), the most common adverse reactions occurring in ≥15% of patients were fatigue, musculoskeletal pain, diarrhea, rash, pruritus, and upper respiratory tract infection. Serious adverse events occurred in 32% of patients.Adverse Reactions, the most common (occurring in at least 2 patients) were urinary tract infection, colitis, acute kidney injury, adrenal insufficiency,Anemia、TumorInfection and somnolence leading to permanent discontinuationAdverse ReactionsOccurred in 13% of patients; the most common adverse reactions (occurring in at least two patients) were colitis and general deterioration of health.

Libtayo belongs to the class of anti-PD-(L)1 inhibitors, a currently highly regarded category of cancer immunotherapy that aims to harness the body’s own immune system to fight cancer by blocking the PD-1/PD-L1 signaling pathway, thereby inducing cancer cell death, and is indicated for the treatment of 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 inhibiting T cell activation via the PD-1 pathway.

In the United States, the European Union, and other countries, Libtayo has been approved for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation therapy. Libtayo was created and optimized using Regeneron’s proprietary Velocimmune® technology platform and is currently being co-developed under the 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.

In addition to CSCC and BCC, Libtayo for the treatment of non-small cell lung cancer (NSCLC) is under review in the United StatesFDAreview, with results expected by the end of February. (Bioon.com)

Original Source:FDA approves Libtayo® (Cemiplimab-rwlc) as first immunotherapy indicated for patients with advanced basal cell carcinoma