Dr Kotecha on the FDA Approval of Optune Lua in Metastatic NSCLC

Rupesh Rajesh Kotecha, MD, radiation oncologist, chief of Radiosurgery, director of Central Nervous System Metastasis, Miami Cancer Institute, discusses the FDA approval of Optune Lua, a tumor treating fields (TTF) device, in metastatic non–small cell lung cancer.

On October 15, 2024, the FDA approved Optune Lua for concurrent use with PD-1/PD-L1 inhibitors or docetaxel in adult patients with metastatic NSCLC whose disease has progressed on or after a platinum-based regimen.

The regulatory decision was based on the results of the phase 3 LUNAR trial (NCT02973789), which investigated TTFields plus standard-of-care (SOC) immune checkpoint inhibitors or docetaxel vs immune checkpoint inhibitors or docetaxel alone in patients with metastatic NSCLC. This trial was important for the NSCLC field, particularly in regard to the development of treatments outside of the traditional systemic therapy realm, Kotecha says.

The LUNAR trial demonstrated that patients given Optune Lua concurrently with a PD-1/PD-L1 inhibitor or docetaxel (n = 145) experienced a median overall survival (OS) of 13.2 months (95% CI, 10.3-15.5) compared with 9.9 months (95% CI, 8.2-12.2) for those given a PD-1/PD-L1 inhibitor or docetaxel alone (n = 146; P = .04).

The use of Optune Lua plus an immune checkpoint inhibitor (n = 66) generated a median OS of 18.5 months (95% CI, 10.6-30.3) vs 10.8 months (95% CI, 8.2-18.4) for a checkpoint inhibitor alone (n = 68; HR, 0.63; 95% CI, 0.41-0.96; P = .030). Optune Lua plus docetaxel (n = 71) produced a median OS of 11.1 months (95% CI, 8.2-14.1) vs 8.7 months (95% CI, 6.3-11.3) for docetaxel alone (HR, 0.81; 95% CI, 0.55-1.19; P = .28).

The addition of Optune Lua to the current SOC second-line treatment regimens for patients with NSCLC offers a new option for those whose disease has progressed on or after platinum-based therapy. Notably, the use of TTFields concurrently with SOC options was not associated with an increase in adverse effects that would impact quality of life, Kotecha concludes.