Novocure has received CE mark approval for its Optune Lua device to treat adult patients with metastatic non-small cell lung cancer (NSCLC) in combination with immune checkpoint inhibitors or docetaxel, following progression on a platinum-based regimen.
Optune Lua is a portable device that delivers alternating electric fields, known as TTFields, through non-invasive, wearable arrays.
The TTFields apply physical forces to the electrically charged components of dividing cancer cells, leading to cell death.
The approval represents a significant step in the availability of Tumour Treating Fields (TTFields) therapy for lung cancer patients in Europe.
Novocure is currently initiating local registration for Optune Lua in Germany and plans to launch in the coming weeks.
Novocure Oncology president Frank Leonard said: “The CE mark approval for Optune Lua for metastatic non-small cell lung cancer is a significant milestone in Novocure’s efforts to improve outcomes for people living with aggressive cancers.
“Tumour Treating Fields therapy has demonstrated effectiveness in multiple tumour types that have historically been very difficult to treat, including lung cancer.
“We believe the efficacy Optune Lua can offer, paired with its lack of systemic toxicity, has the potential to change the way late-stage lung cancer is treated.”
The CE mark approval follows the US Food and Drug Administration (FDA) approval in October last year and is supported by data from the Phase 3 LUNAR trial.
The Phase 3 trial evaluated the safety and efficacy of Optune Lua used with immune checkpoint inhibitors or docetaxel, compared to the use of these drugs alone.
It has achieved the primary endpoint of showing a statistically significant and clinically meaningful 3.3-month extension in median overall survival (OS) with Optune Lua.
Patients receiving Optune Lua with an immune checkpoint inhibitor or docetaxel had a median OS of 13.2 months, compared to 9.9 months for those receiving only the drugs.
Further analysis revealed that patients treated with Optune Lua and an immune checkpoint inhibitor experienced a 7.7-month extension in median OS.
Novocure plans to conduct a post-market study of TTFields combined with docetaxel in metastatic NSCLC patients to assess overall survival in a routine care setting.
The trial will involve 180 patients with a 12-month follow-up, comparing results to a matched control group treated only with docetaxel.
Previously, Optune Lua received CE mark approval for treating stage 4 non-squamous NSCLC in combination with pemetrexed after the failure of first-line treatments.
LUNAR study investigator Joachim Aerts said: “Optune Lua is an innovative and urgently needed new approach for treating metastatic non-small cell lung cancer.
“There are few treatment options for people living with this aggressive cancer. In fact, the results from the Phase 3 trial of Optune Lua were the first in more than eight years to show a treatment providing a significant extension in overall survival.
“These results and the lack of systemic toxicity observed with Optune Lua provide patients with a promising new treatment option.”
