NovoCure’s Optune Lua, a wearable indicated for use alongside PD-1/PD-L1 inhibitors (immunotherapy) or docetaxel in adult patients with metastatic non-small cell lung cancer (mNSCLC) has received approval from the US Food and Drug Administration (FDA).

Approved on the basis of positive Phase III data, the treatment is aimed at patients whose form of cancer has continued to progress on or after a platinum-based regimen.

The Swiss company’s device delivers what NovoCure calls Tumour Treating Fields (TTFields), or electrical signals, by way of wearable arrays placed directly on the skin. According to the company, the TTFields delivered exert physical forces on the electrically charged components of dividing cancer cells, resulting in cell death.

The randomised, open-label Phase III LUNAR trial (NCT02973789) of 291 patients with metastatic NSCLC who experienced disease progression during or after platinum-based chemotherapy met its primary endpoint. It demonstrated a statistically significant and clinically meaningful 3.3 month extension in median overall survival (OS) for patients treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor or docetaxel.

Patients in the cohort administered with Optune Lua concurrently with a PD-1/PD-L1 inhibitor or docetaxel had a median OS of 13.2 months, versus a median OS of 9.9 months in the PD-1/PD-L1 inhibitor or docetaxel treated cohort.

Dr Ticiana Leal, associate professor and director of the thoracic oncology program at the Winship Cancer Institute and primary investigator on the LUNAR study siad: “The OS results we observed with Optune Lua in the LUNAR study mark the first substantial improvement in more than eight years in this patient population which, when combined with Optune Lua’s lack of systemic toxicity, make this a compelling development for many patients and their physicians who need better treatment options for this advanced disease.”

According to the World Health Organization (WHO), lung cancer is the leading cause of cancer-related deaths worldwide and was responsible for an estimated 1.8 million (18%) of all cancer deaths in 2020.

NovoCure CEO Asaf Danziger said: “The approval of Optune Lua brings a new and urgently needed option for people with metastatic NSCLC who have progressed while on or after platinum-based chemotherapy.”

In March 2024, NovoCure’s TTFields therapy administered with its NovoTTF-200T device, which received breakthrough designation from the FDA in 2021, met its primary endpoint in the company’s Phase III METIS trial (NCT02831959) by slowing the progression of brain metastasis in NSCLC patients.