Libtayo (Cemiplimab) Plus Chemotherapy Significantly Improves Overall Survival in First-Line Treatment of Advanced NSCLC: Phase 3 EMPOWER-Lung 3 Trial Results

October 13, 2021 /BioonBIOON/ -- Sanofi and its partner Regeneron recently announced the evaluationAnti-PD-1 therapy Libtayo (cemiplimab) in combination with platinum-based doublet chemotherapy for advanced non-small cell lung cancer (NSCLC)Positive results from the Phase 3 EMPOWER-Lung 3 trial in patients. The trial was conducted in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), regardless of histology and PD-L1 expression levels, evaluating the anti-PD-1 therapy Libtayo (cemiplimab) in combination with platinum-based doublet chemotherapy compared with platinum-based doublet chemotherapy.

This trial enrolled patients with locally advanced or metastatic disease,TumorIn patients with squamous or non-squamous histology across all PD-L1 expression levels, Libtayo plus chemotherapy was compared with chemotherapy alone. The results showed that,The trial met the primary endpoint of overall survival (OS) and all key secondary endpoints.. In the overall study population, compared with the chemotherapy group (n=154),Patients in the Libtayo + chemotherapy group (n=312) experienced significant improvement., including:

——Overall Survival (OS): Compared with the chemotherapy group, the Libtayo + chemotherapy group demonstrated significantly prolonged OS (median OS: 22 months vs. 13 months) and a 29% reduction in the risk of death (HR = 0.71; 95% CI: 0.53–0.93; p = 0.014). The 12-month survival rate was 66% for the Libtayo + chemotherapy group and 56% for the chemotherapy group.

——Progression-Free Survival (PFS)：Compared with the chemotherapy group, the Libtayo + chemotherapy group demonstrated a significantly prolonged PFS (median PFS: 8 months vs. 5 months) and a 46% reduction in the risk of disease progression or death (HR = 0.54; 95% CI: 0.44–0.70; p < 0.0001). The 12-month progression-free survival rate was 38% in the Libtayo + chemotherapy group versus 16% in the chemotherapy group.

——Relief: In the Libtayo plus chemotherapy group, the objective response rate (ORR) was 43% and the median duration of response (DOR) was 16 months; in the chemotherapy group, the ORR was 23% and the median DOR was 7 months.

——Patient-Reported Outcomes: Favorable patient-reported outcomes were observed in this trial. Specifically, compared with chemotherapy, Libtayo plus chemotherapy delayed the worsening of pain symptoms (HR=0.39; 95% CI: 0.26-0.60; nominal p<0.0001) and demonstrated a trend toward delayed worsening of overall health status/quality of life (HR=0.78; 95% CI: 0.51-1.19; nominal p=0.248). Compared with chemotherapy, Libtayo plus chemotherapy also improved pain symptoms (between-group difference=-4.98; 95% CI: -8.36 to -1.60; nominal p=0.004).

——Safety: No new Libtayo safety signals were identified in this trial.

Data from the Phase 3 EMPOWER-Lung 3 trial will serve as the basis for regulatory submission documents in the United States and the European Union. Combined with previousClinical Trial，Libtayo has now been demonstrated to significantly improve overall survival (OS) as a first-line monotherapy or in combination with chemotherapy for advanced NSCLC.。

Lung cancer is the leading cause of cancer-related mortality worldwide. In 2020, there were 2.2 million newly diagnosed cases globally and 225,000 in the United States. Approximately 84% of lung cancer cases are non-small cell lung cancer (NSCLC), with 75% of these diagnosed at an advanced stage. While PD-1 inhibitor monotherapy has primarily advanced the treatment of NSCLC with PD-L1 expression ≥50%, approximately 70% of NSCLC patients exhibit PD-L1 expression <50%, representing the most common clinical scenario for treatment.

Libtayo belongs to the class of anti-PD-(L)1 inhibitors, a highly promising category of cancer immunotherapy currently attracting significant attention. It is 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# Tumorpotential. 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.

Libtayo was generated and optimized using Regeneron's proprietary Velocimmune technology platform and is currently being jointly developed under the framework of 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)

Original Source:Libtayo (cemiplimab) and chemotherapy first-line treatment combination significantly improved overall survival in patients with advanced NSCLC