Novocure's Optune Lua Approved in Japan for NSCLC

By Tamara Parker • Monday, September 15 10:11 • Permanent Link

Novocure (NASDAQ: NVCR) has announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has approved Optune Lua for the treatment of adult patients with unresectable advanced/recurrent non-small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy. This follows the results of the phase 3 LUNAR trial that showed a statistically significant and clinically meaningful improvement in median overall survival for NSCLC patients treated with Optune Lua.

The pivotal phase 3 LUNAR trial demonstrated a 3.3-month extension in median overall survival for patients treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor or docetaxel, compared to the control group. The group treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor or docetaxel had a median overall survival of 13.2 months, compared to 9.9 months in the control group.

Furthermore, patients treated with Optune Lua and a PD-1/PD-L1 inhibitor demonstrated a statistically significant extension in median overall survival of more than 8.0 months, with a median overall survival of 19.0 months compared to 10.8 months in the control group.

In terms of adverse events, device-related adverse events occurred in 63.1% of patients, with the majority being low grade (grade 1 * 2) skin-related disorders. There were no grade 4 or grade 5 toxicities related to Optune Lua, and no device-related adverse events that caused death.

The approval of Optune Lua in Japan provides a new treatment option for patients with advanced non-small cell lung cancer and addresses the urgent need for innovative treatment options for this disease. Novocure is focused on launching Optune Lua as quickly as possible in Japan to make the therapy accessible to patients experiencing progression after initial platinum-based treatment.

This approval in Japan further solidifies Novocure's position as a global oncology company working to extend survival in aggressive forms of cancer through the development and commercialization of innovative therapies. Following these announcements, the company's shares moved -4.56%, and are now trading at a price of $12.15. For the full picture, make sure to review NovoCure Ltd's 8-K report.

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