Statistics show that approximately 25%-30% of all non-small cell lung cancer (NSCLC) cases exhibit high PD-L1 expression (TPS > 50%). While immunotherapy has revolutionized treatment for advanced NSCLC patients in recent years, the identification and treatment of patients with high PD-L1 expression still require optimization. Recently, the European Commission (EC) approved the anti-PD-L1 therapy Libtayo (cemiplimab) as a monotherapy for first-line treatment of advanced NSCLC patients with tumors that highly express PD-L1.
Libtayo International Research Data
EC's approval for advanced non-small cell lung cancer (NSCLC) is based on data from a global phase 3 trial that enrolled 710 patients from 24 countries. This trial is one of the largest trials of PD-1 inhibitors for advanced NSCLC, aiming to better reflect clinical practice by including challenging treatments and often underrepresented disease characteristics. Among the enrollees, 12% had pre-treatment and clinically stable brain metastases, 44% had squamous cell histology, and 16% had locally advanced NSCLC who were ineligible as candidates for final chemoradiotherapy. Furthermore, patients whose disease progressed during the trial were able to change their treatment regimen: those receiving chemotherapy could crossover to Libtayo, while those receiving Libtayo monotherapy could continue with Libtayo and add four more cycles of chemotherapy.
Results showed that, in the entire study population, Libtayo significantly reduced the risk of death by 32% and prolonged median overall survival (OS) by 8 months compared to chemotherapy, even though 74% of patients switched to Libtayo after disease progression following chemotherapy (hazard ratio [HR]: 0.68; 95% confidence interval [CI]: 0.53–0.87; p = 0.0022). The median OS for Libtayo was 22 months (range: 18 months to non-evaluable), compared to 14 months for chemotherapy (range: 12–19 months). A pre-specified analysis of data from patients with PD-L1-expressing cancers (≥50%, n=563) showed, based on validation, that Libtayo reduced the risk of death by 43% in this population; Libtayo did not reach median OS (95% CI: 18 months to non-evaluable), compared to 14 months for chemotherapy (95% CI: 11–18 months).
In the phase 3 trial, safety was assessed in 697 patients, with exposure time of 27 weeks (range: 9 days to 115 weeks) in the Libtayo group and 18 weeks (range: 18 days to 87 weeks) in the chemotherapy group. Serious adverse events (AEs) occurred in at least 2% of patients: pneumonitis (5% ribavirin, 6% chemotherapy) and pneumonitis (2% ribavirin, 0% chemotherapy). 6% of Libtayo patients permanently discontinued treatment due to adverse events; adverse events leading to permanent discontinuation in at least two patients were pneumonitis, pneumonia, ischemic stroke, and elevated aspartate aminotransferase. No new safety signals for Libtayo were observed.
Libtayo drug introduction
Product name: Libtayo
Drug name: Cemiplimab
Manufacturer: Sanofi, Regeneron
Libtayo (Cemiplimab) 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 through 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 suitable for radical surgery or radical radiotherapy. Additionally, Libtayo was the first immunotherapy approved for the treatment of basal cell carcinoma (BCC).
Reminder: The research results show that Libtayo monotherapy has significantly improved the total survival and non-progressive survival of patients with advanced non-small cell lung cancer with high PD-L1 expression. The approval of Libtayo also provides a new treatment plan for this patient population.
