• 17 Oct 2024
• Admin
• News Article

Novocure's Optune Lua® Approved by FDA for Treating Metastatic Non-Small Cell Lung Cancer

Overview

Novocure announced the approval of Optune Lua® by the U.S. Food and Drug Administration (FDA) for use alongside PD-1/PD-L1 inhibitors or docetaxel in treating adult patients with metastatic non-small cell lung cancer (mNSCLC) who have progressed following platinum-based chemotherapy.

About NSCLC

• Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, representing about 85% of all cases. 
• It remains the leading cause of cancer-related deaths worldwide, with around 193,000 new cases diagnosed annually in the U.S. 

About the Device: Optune Lua

• Optune Lua is a portable device that generates alternating electric fields, known as tumour treating fields (TTFields), which are applied via non-invasive, wearable arrays. 
• These fields target dividing cancer cells, disrupting their internal components and leading to cell death. 
• This treatment has shown promising results, particularly in extending the overall survival of patients.

Limited treatments: - Although recent advances have been made in first-line treatments for NSCLC, many patients experience disease progression and have limited options in later stages of treatment. 

LUNAR Study Outcomes

• The results from the LUNAR study, which led to the approval, indicated that patients treated with Optune Lua in combination with PD-1/PD-L1 inhibitors or docetaxel saw a median overall survival extension of 3.3 months compared to those who received PD-1/PD-L1 inhibitors or docetaxel alone.
• The study was a Phase 3, randomised, open-label, multicentre trial. 
• The primary endpoint was achieved with the Optune Lua group showing a median overall survival of 13.2 months compared to 9.9 months in the control group. 
• A secondary analysis demonstrated a significant survival benefit of over 8 months for patients treated with Optune Lua in combination with PD-1/PD-L1 inhibitors. 
• However, when used alongside docetaxel, the improvement in survival was 2.2 months, which did not reach statistical significance but showed a positive trend.

Associated Adverse Events

• Adverse events associated with the device were mainly skin-related, occurring in 63.1% of patients, though most were mild to moderate in severity. 
• Only a small number (4%) experienced more severe skin reactions requiring a temporary pause in treatment. 
• No serious or fatal events related to the device were reported.

Impact of Approval

The approval of Optune Lua provides an additional treatment option for patients with advanced NSCLC, offering a potential improvement in survival with fewer systemic side effects.