Optune Lua Secures Japanese Approval for Advanced NSCLC

Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Optune Lua for concurrent use with PD-1/PD-L1 inhibitors in adult patients with unresectable, advanced/recurrent non–small cell lung cancer (NSCLC) who progressed on or after platinum-based chemotherapy.1

The regulatory decision was supported by data from the phase 3 LUNAR trial (NCT02973789), which demonstrated that patients treated with Optune Lua—a tumor-treating fields (TTFields) device—plus PD-1/PD-L1 inhibition or docetaxel (n = 145) achieved 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 PD-1/PD-L1 inhibition or docetaxel alone (n = 146; P = .04).

Notably, the study showed a statistically significant improvement in OS for Optune Lua plus PD-1/PD-L1 inhibition vs checkpoint inhibition alone, meeting one key secondary end point. However, another key secondary end point was not met, with Optune Lua plus docetaxel failing to improve OS in a statistically significant manner vs docetaxel alone.

Patients treated with Optune Lua plus a PD-1/PD-L1 inhibitor (n = 70) experienced a median OS of 19.0 months (95% CI, 10.6-28.2) vs 10.8 months (95% CI, 8.3-17.6) for those given a PD-1/PD-L1 inhibitor alone (n = 71; P = .02).

Optune Lua plus docetaxel (n = 75) yielded a median OS of 11.1 months (95% CI, 8.2-13.9) compared with 8.9 months (95% CI, 6.5-11.3) for docetaxel alone (n = 75).

“With the MHLW approval granted to Optune Lua, we now have a new treatment option available to patients with advanced NSCLC,” said Tetsuya Mitsudomi, MD, president of Izumi City General Hospital in Japan, stated in a news release. “The phase 3 LUNAR trial showed that use of Optune Lua resulted in improved OS rates without severe [adverse] effects [AEs], resulting in a significant benefit for patients with this aggressive disease.”

In October 2024, the FDA approved Optune Lua for concurrent use with PD-1/PD-L1 inhibitors or docetaxel for the treatment of adult patients with metastatic NSCLC whose disease has progressed on or after a platinum-based regimen.2 This approval was also based on findings from LUNAR.

How Did the LUNAR Trial Investigate the Use of TTFields?

The randomized, open-label trial enrolled patients at least 22 years of age with metastatic, squamous or nonsquamous NSCLC whose disease progressed on or after platinum-based chemotherapy.3 Key inclusion criteria comprised an ECOG performance status of 2 or less and prior treatment with a platinum-based regimen. However, there was no limit on prior lines of systemic therapy.4

Investigators randomly assigned patients 1:1 to receive TTFields in combination with investigator's choice of concurrent standard systemic therapy; or systemic therapy alone. Investigator's choice of therapy included nivolumab (Opdivo), pembrolizumab (Keytruda), atezolizumab (Tecentriq), or docetaxel.3,4 Optune Lua was given at 150 kHz continuously to the thoracic region with a target average of 18 hours per day of device usage.

Along with the primary end point of OS, other secondary end points included OS for Optune Lua plus docetaxel vs checkpoint inhibition alone; progression-free survival; overall response rate; quality of life; and safety.3

What is the Safety Profile of Optune Lua?

Safety data from LUNAR demonstrated that 63.1% of patients in the experimental arm experienced device-related (AEs), and the majority of these skin-related disorders were low grade.1 Grade 3 skin toxicity that required a break from treatment occurred in 4% of patients. No grade 4/5 Optune Lua–related AEs were reported, and no device-related AEs led to death.

References

1. Novocure’s Optune Lua receives approval in Japan for the treatment of unresectable advanced/recurrent non-small cell lung cancer (NSCLC). News release. Novocure. September 15, 2025. Accessed September 17, 2025. https://www.novocure.com/novocures-optune-luar-receives-approval-japan-treatment-unresectable-advancedrecurrent-non-small
2. FDA approves Novocure’s Optune Lua for the treatment of metastatic non-small cell lung cancer. News release. Novocure. October 15, 2024. Accessed September 17, 2025. https://www.novocure.com/fda-approves-novocures-optune-lua-for-the-treatment-of-metastatic-non-small-cell-lung-cancer/
3. Effect of tumor treating fields (TTFields) (150 kHz) concurrent with standard of care therapies for treatment of stage 4 non-small cell lung cancer (NSCLC) following platinum failure (LUNAR). ClinicalTrials.gov. Updated October 21, 2024. Accessed September 17, 2025. https://clinicaltrials.gov/study/NCT02973789
4. Leal T, Kotecha R, Ramlau R, et al. Tumor treating fields therapy with standard systemic therapy versus standard systemic therapy alone in metastatic non-small-cell lung cancer following progression on or after platinum-based therapy (LUNAR): a randomised, open-label, pivotal phase 3 study. Lancet Oncol. 2023;24(9):1002-1017. doi:10.1016/S1470-2045(23)00344-3