BAAR, Switzerland– Novocure (NASDAQ: NVCR) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Optune Lua® for concurrent use with PD-1/PD-L1 inhibitors in adult patients with unresectable advanced or recurrent non-small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy.
The approval was supported by results from the pivotal Phase 3 LUNAR trial, which demonstrated a statistically significant and clinically meaningful improvement in overall survival for NSCLC patients treated with Optune Lua.
“With the Ministry of Health, Labour and Welfare approval granted to Optune Lua, we now have a new treatment option available to patients with advanced non-small cell lung cancer,” said Dr. Tetsuya Mitsudomi, President of Izumi City General Hospital. “The Phase 3 LUNAR trial showed that use of Optune Lua resulted in improved overall survival rates without severe side effects, resulting in a significant benefit for patients with this aggressive disease.”
Optune Lua is a wearable, portable medical device that delivers alternating electric fields, known as Tumor Treating Fields (TTFields), through non-invasive arrays placed on the patient’s body. These fields exert physical forces on dividing cancer cells, leading to disruption of cell division and cancer cell death.
“Lung cancer is the leading cause of cancer-related death worldwide, and unfortunately, in Japan the number of cases continues to increase, which is why we see an urgent need for innovative treatment options for this disease,” said Frank Leonard, President of Novocure. “Novocure is focused on launching Optune Lua as quickly as possible in Japan so that patients with non-small cell lung cancer experiencing a progression after initial platinum-based treatment have access to our therapy.”
In the Phase 3 LUNAR trial, patients treated with Optune Lua and a PD-1/PD-L1 inhibitor or docetaxel achieved a median overall survival of 13.2 months, compared with 9.9 months for patients treated with PD-1/PD-L1 inhibitors or docetaxel alone. Patients who received Optune Lua in combination with a PD-1/PD-L1 inhibitor demonstrated a median overall survival of 19.0 months, compared with 10.8 months in the control group. The trial also showed that the device was generally well tolerated, with most adverse events limited to mild-to-moderate skin reactions under the transducer arrays.
Non-small cell lung cancer accounts for approximately 85 percent of all lung cancers, with an estimated 120,000 new cases diagnosed each year in Japan. Physicians typically treat NSCLC with surgery, radiation, chemotherapy, and immunotherapy, depending on disease stage. The approval of Optune Lua offers a new option for patients facing this difficult-to-treat cancer.
