On Tuesday, the FDA approved NovoCure's (NASDAQ:NVCR) Optune Lua for concurrent use with PD-1/PD-L1 inhibitors or docetaxel for adult patients with metastatic non-small cell lung cancer (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), delivered through non-invasive, wearable arrays.

TTFields exert physical forces on the electrically charged components of dividing cancer cells, resulting in cell death.

"The overall survival 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," said Ticiana Leal, primary investigator of the LUNAR study.

Also Read: Novocure Stock Soars, Its Lung Cancer Electric Field Treatment Slows Progression To Brain, Data Shows.

The primary endpoint of the Phase 3 LUNAR study was achieved, demonstrating a statistically significant and clinically meaningful 3.3-month (P=0.04) extension in median overall survival (OS) for patients treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor or docetaxel (n=145).

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.

The LUNAR study included two pre-specified powered secondary endpoints.

The first secondary endpoint, which met statistical significance, assessed median OS in patients treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor versus a PD-1/PD-L1 inhibitor alone. The second secondary endpoint, which showed a positive trend but did not meet statistical significance, assessed Optune Lua concurrently with docetaxel versus docetaxel alone.

Patients randomized to Optune Lua and a PD-1/PD-L1 inhibitor (n=70) demonstrated a median OS of 19.0 months compared to 10.8 months in patients treated with PD-1/PD-L1 inhibitor alone (n=71), which was a statistically significant extension in median OS of more than 8.0 months (P=0.02).

Patients randomized to receive Optune Lua and docetaxel (n=75) had a median OS of 11.1 months compared to 8.9 months in patients treated with docetaxel alone (n=75). This 2.2-month extension in median OS did not provide a statistically significant demonstrated benefit but did show a positive trend.

Price Action: NVCR stock is up 26.20% at $22.44 during the premarket session at last check on Wednesday.

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