FDA approves Novocure's Optune Lua for metastatic NSCLC after platinum progression

NovoCure Ltd

Optune Lua approved for concurrent use with PD-1/PD-L1 inhibitors or docetaxel in patients with mNSCLC who progressed on/after platinum-based therapy.
Phase 3 LUNAR trial: median OS 13.2 months (Optune Lua + therapy) vs 9.9 months (control); 3.3-month gain (P=0.04).
In PD-1/PD-L1 subgroup, median OS 19.0 months vs 10.8 months; 8.2-month gain (P=0.02).
Device-related AEs in 63.1% of patients; mostly low-grade skin toxicity; no Grade 4/5 or deaths.
First substantial OS improvement in >8 years for this patient population; wearable TTFields device.

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