EU Approves Sanofi/Regeneron’s Anti-PD-1 Therapy Libtayo for Two Advanced Cancers: NSCLC and Basal Cell Carcinoma
Jun 27, 2021 02:05
CST Updated
02:05
Sanofi
Pharmaceutical R&D Developer
Regeneron
Biopharmaceutical Manufacturer
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
June 26, 2021 /BioonBIOON/ -- Sanofi and partner Regeneron recently jointly announced that the European Commission (EC) has approved the anti-PD-1 therapy Libtayo (cemiplimab) as a monotherapy for the treatment of two advanced cancers. Specifically: (1) as first-line treatment for tumors with high PD-L1 expression (TPS ≥50%), metastatic or locally advanced disease, not amenable to surgical resection or definitive chemoradiotherapy,TumorAdult patients with advanced non-small cell lung cancer (NSCLC) without EGFR/ALK/ROS1 genomic alterations; (2) for adult patients with locally advanced or metastatic basal cell carcinoma (BCC) who have progressed on, or are intolerant to, prior hedgehog pathway inhibitor (HHI) therapy.
In 2019, Libtayo was first approved in the European Union for the treatment of patients with advanced cutaneous squamous cell carcinoma (CSCC), specifically indicated for: patients with metastatic CSCC and patients with locally advanced CSCC who are not candidates for curative surgery or curative radiotherapy.
To date,Libtayo has been approved in the European Union for the treatment of three advanced cancers (CSCC, NSCLC, BCC)..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.
Lung cancer is the leading cause of cancer death worldwide, with over 2 million new cases diagnosed annually. Approximately 85% of lung cancers are non-small cell lung cancer (NSCLC), with an estimated 25%–30% of cases exhibiting high PD-L1 expression (≥50% ofTumorPD-L1 positivity was detected in the cells). In recent years, although immunotherapy has transformed the treatment of patients with advanced NSCLC, there remains a need to optimize the identification and treatment of patients with high PD-L1 expression.
The EC approval of Libtayo for the first-line treatment of advanced NSCLC with high PD-L1 expression is based on data from the pivotal Phase 3 EMPOWER-Lung 1 study. The study in ≥50%TumorThe study was conducted in patients with locally advanced or metastatic NSCLC whose tumors express PD-L1. Data showed that, compared with platinum-based doublet chemotherapy, first-line treatment with Libtayo significantly prolonged overall survival (OS).
AlthoughFollowing disease progression, a very high proportion of patients in the chemotherapy arm crossed over to the Libtayo arm for treatment (crossover rate: 74%)., Libtayo remains superior to chemotherapy in prolonging OS: (1)In the overall study population, Libtayo reduced the risk of death by 32% compared with chemotherapy., median OS was 22 months in the Libtayo treatment group and 14 months in the chemotherapy group. (2)In patients with PD-L1 expression ≥50%, Libtayo reduced the risk of death by 43% compared with chemotherapy.，the median OS in the Libtayo arm was not reached, compared with 14 months in the chemotherapy arm.
Basal cell carcinoma (BCC, Image source: sciencephoto.com)
Basal cell carcinoma (BCC) is the most common type of skin cancer worldwide. Although the vast majority of BCCs are detected early and can be easily cured with surgery and radiation therapy, a small minorityTumormay progress to an advanced stage and invade surrounding tissues (locally advanced), which is more difficult to treat.
The EC's approval of Libtayo for the treatment of locally advanced or metastatic BCC is based on data from a Phase II clinical trial (NCT03132636), the largest prospective study to date in these patients.Clinical Trialresults.
The results show: (1)In patients with metastatic BCC (mBCC), the overall response rate (ORR) was 21% at a median follow-up of 9.5 months., median duration of response (DOR) has not yet been 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 have a DOR ≥ 1 year, the 1-year progression-free survival rate is 57%, and the 1-year overall survival rate is 92%.
Libtayo is an anti-PD-(L)1 inhibitor, a highly prominent class of cancer immunotherapy currently, designed 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 is capable of treating multiple types ofTumorpotential. Libtayo is a fully human monoclonal antibody targeting 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.
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. (Bioon.com)