FDA Approves Tumor Treating Fields Therapy for Metastatic NSCLC

By: JNCCN 360 Staff
Posted: Thursday, October 17, 2024

Novocure recently announced the U.S. Food and Drug Administration (FDA) approval of Optune Lua^® for concurrent use with PD-1/PD-L1 inhibitors or docetaxel for the treatment of adults with metastatic non–small cell lung cancer (NSCLC) who have experienced disease progression on or after a platinum-based regimen. This wearable treatment device delivers alternating electric fields to disrupt processes that are critical for cancer cell survival.

This approval is based on data from the phase III LUNAR trial, a prospective, randomized, open-label, multicenter study. This trial compared the use of tumor treating fields therapy concurrently with PD-1/PD-L1 inhibitors or docetaxel (experimental arm) with PD-1/PD-L1 inhibitors or docetaxel alone (control arm) for patients with metastatic NSCLC who experienced disease progression during or after platinum-based therapy.

The primary endpoint of the study was achieved, with a statistically significant and clinically meaningful 3.3-month (P = .04) improvement in median overall survival for the 145 patients given tumor treating fields concurrently with a PD-1/PD-L1 inhibitor or docetaxel. For the 146 patients given tumor treating fields therapy concurrently with a PD-1/PD-L1 inhibitor or docetaxel, the median overall survival was 13.2 months (95% confidence interval [CI] = 10.3–15.5 months) vs 9.9 months (95% CI = 8.2–12.2 months) for those given the PD-1/PD-L1 inhibitor or docetaxel.

Patients randomly assigned to receive the tumor treating fields therapy and a PD-1/PD-L1 inhibitor (n = 70) had a median overall survival of 19.0 months (95% CI = 10.6–28.2 months) vs 10.8 months (95% CI = 8.3–17.6 months) in patients treated a with PD-1/PD-L1 inhibitor alone (n = 71), which was a statistically significant improvement in median overall survival of more than 8 months (P = .02). Patients randomly assigned to receive tumor treating fields therapy and docetaxel (n = 75) had a median overall survival of 11.1 months (95% CI = 8.2–13.9 months) vs 8.9 months (95% CI = 6.5–11.3 months) in patients treated with docetaxel alone (n = 75). This 2.2-month improvement in median overall survival did not provide a statistically significant demonstrated benefit but did show a positive trend.

Device-related adverse events (skin-related disorders under the transducer arrays) occurred in 63.1% of patients (n = 89). The majority of these events were grade 1 or 2. No grade 4 or 5 toxicities related to the tumor treating fields therapy nor device-related adverse events that caused death were reported.

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