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

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.