Optune Lua Granted CE Mark Approval in EU for Metastatic NSCLC

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Optune Lua has received a Conformité Européenne (CE) Mark in concurrent use with immune checkpoint inhibitors (ICIs) or docetaxel for the treatment of adults in the European Union with metastatic non-small cell lung cancer (NSCLC) who have progressed on or after a platinum-based regimen, according to a recent announcement from the device’s developer, Novocure.1

Optune Lua is a wearable medical device that delivers Tumor Treating Fields (TTFields), a means of treating metastatic NSCLC via electric fields to kill cancer cells.

Data from the phase 3 LUNAR study (NCT02973789) supported this regulatory decision, demonstrating a median overall survival (OS) of 13.2 months (95% CI, 10.3-15.5) with TTFields (n = 137) compared with 9.9 months (95% CI, 8.2-11.5) in the control arm (n = 139; P = .035). Moreover, patients who received TTFields plus ICIs achieved a median OS of 18.5 months (95% CI, 10.6-30.3) vs 10.8 months (95% CI, 8.2-18.4) for ICIs alone (P = .03). Patients treated with TTFields combined with docetaxel (n = 71) yielded a median OS of 11.1 months (95% CI, 8.2-14.1) vs 8.7 months (95% CI, 6.3-11.3) in those treated with docetaxel alone (n = 71).

Regarding safety, skin-related adverse effects occurred in 65.4% (n = 87) of patients, primarily grade 1/2, with grade 3 events in 5% (n = 6); no grade 4/5 toxicities or device-related deaths were reported.

“Optune Lua is an innovative and urgently needed new approach for treating metastatic NSCLC” Joachim Aerts, MD, a trial investigator and professor of Pulmonary Oncology at Erasmus MC Cancer Institute, stated in the press release. “There are few treatment options for people living with this aggressive cancer. In fact, the results from the phase 3 trial of Optune Lua were the first in more than 8 years to show a treatment providing a significant extension in OS. These results and the lack of systemic toxicity observed with Optune Lua provide patients with a promising new treatment option.”

LUNAR was a prospective, randomized controlled study evaluating the efficacy and safety of TTFields in patients with squamous or non-squamous, inoperable stage IV NSCLC who experienced disease progression on or after receiving platinum-based chemotherapy for advanced or metastatic disease.2 Patients were also required to be at least 22 years of age or older, with some regional variations; have a life expectancy of 3 or more months and have an ECOG performance status between 0 and 2.

Eligible patients were randomly assigned 1:1 to receive either TTFields using the NovoTTF-200T device plus ICIs or docetaxel, or ICIs or docetaxel alone. Treatment with TTFields consisted of wearing 4 electrically insulated electrode arrays on the chest, which enabled patients to maintain a regular daily routine. Treatment on both arms continued until disease progression per RECIST or irRECIST criteria, at which point patients switched to a third-line therapy according to local practice.

The trial’s primary end point was OS. Secondary end points included progression-free survival, overall radiological response rate, quality of life, and safety.

Notably, data from LUNAR also supported the October 2024 FDA approval of Optune Lua for concurrent use with PD-(L)1 inhibitors or docetaxel in adult patients with metastatic NSCLC with disease progression on or following a platinum-based regimen.3

Local registration for Optune Lua has begun in Germany and is anticipated to become available in the next few weeks.1 As part of the CE Mark approval conditions, Novocure plans to initiate a post-market study evaluating Optune Lua in combination with docetaxel in patients with metastatic NSCLC. The study will enroll 180 patients and include a 12-month follow-up period, with outcomes compared against a matched control cohort receiving docetaxel alone to assess overall survival in a real-world setting.

“The CE Mark approval for Optune Lua for metastatic NSCLC is a significant milestone in Novocure’s efforts to improve outcomes for people living with aggressive cancers,” Frank Leonard, president of Novocure Oncology, concluded in the news release. “TTFields therapy has demonstrated effectiveness in multiple tumor types that have historically been very difficult to treat, including lung cancer. We believe the efficacy Optune Lua can offer, paired with its lack of systemic toxicity, has the potential to change the way late-stage lung cancer is treated.”

References

1. Novocure’s Optune Lua® receives CE Mark approval for the treatment of metastatic non-small cell lung cancer. News release. Novocure. April 22, 2025. Accessed April 24, 2025. https://www.novocure.com/novocures-optune-luar-receives-ce-mark-approval-treatment-metastatic-non-small-cell-lung-cancer
2. 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 April 24, 2025. https://www.clinicaltrials.gov/study/NCT02973789
3. FDA approves Novocure’s Optune Lua for the treatment of metastatic non-small cell lung cancer. News release. Novocure. October 15, 2024. Accessed April 25, 2025. https://www.novocure.com/fda-approves-novocures-optune-lua-for-the-treatment-of-metastatic-non-small-cell-lung-cancer/