FDA approves Novocure’s Optune Lua in mNSCLC

Novocure “announced that the FDA has approved Optune Lua(R) for concurrent use with PD-1/PD-L1 inhibitors or docetaxel, for the treatment of adult patients with metastatic non-small cell lung cancer, or mNSCLC, who have progressed on or after a platinum-based regimen. Optune Lua is a portable device that produces alternating electric fields known as tumor treating fields – TTFields- which are delivered through non-invasive, wearable arrays. TTFields exert physical forces on the electrically charged components of dividing cancer cells, resulting in cell death. The Phase 3 LUNAR study was a prospective, randomized, open-label, multicenter study that compared the use of Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel to PD-1/PD-L1 inhibitors or docetaxel alone for patients with metastatic NSCLC who progressed during or after platinum-based therapy. The primary endpoint of the study was achieved demonstrating a statistically significant and clinically meaningful 3.3-month extension in median overall survival for patients treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor or docetaxel. The group treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor or docetaxel had a median OS of 13.2 months compared to a median OS of 9.9 months in the PD-1/PD-L1 inhibitor or docetaxel treated group.”