TTFields Therapy Earns EU Approval in Metastatic Non–Small Cell Lung Cancer

“These results and the lack of systemic toxicity observed with [TTFields] provide patients with a promising new treatment option,” according to Joachim Aerts, MD, an investigator of the phase 3 LUNAR trial (NCT02973789).

Tumor treating fields (TTFields; Optune Lua) in combination with immune checkpoint inhibitors (ICIs) or docetaxel has received the Conformité Européenne (CE) Mark approval as a therapy for patients with metastatic non–small cell lung cancer (NSCLC) who have progressed on or after a platinum-containing regimen, according to a press release from the developers, Novocure.¹

Developers have launched the local registration requirements for TTFields in Germany and are anticipating that the therapy will be available in the coming weeks. Following receipt of the CE Mark, developers will assess TTFields plus docetaxel among patients with metastatic NSCLC in the routine care setting as part of a post-market study.

Supporting data for the CE Mark approval came from the phase 3 LUNAR study (NCT02973789), in which investigators evaluated the efficacy and safety of TTFields plus ICIs or docetaxel vs ICIs or docetaxel alone among those with metastatic NSCLC. Data showed a median overall survival (OS) of 13.2 months (95% CI, 10.3-15.5) in the TTFields arm (n = 137) vs 9.9 months (95% CI, 8.2-11.5) in the comparator arm (n = 139; P = .035).

Specifically, patients assigned to receive TTFields plus ICIs (n = 66) experienced a median OS of 18.5 months (95% CI, 10.6-30.3) vs 10.8 months (95% CI, 8.2-18.4) among those who received ICIs alone (n = 68; P = .03). Additionally, the median OS was 11.1 months (95% CI, 8.2-14.1) in patients who received TTFields plus docetaxel (n = 71) vs 8.7 months (95% CI, 6.3-11.3) among those who were treated with docetaxel alone (n = 71).

Adverse effects (AEs) of skin-related disorders that were associated with the TTFields device occurred in 65.4% (n = 87) of patients, with most toxicities consisting of grade 1/2 events. Grade 3 skin events affected 5% (n = 6) of patients, which resulted in patients requiring a break from therapy. Investigators noted no grade 4/5 toxicities associated with TTFields or device-related AEs resulting in death.

“[TTFields] is an innovative and urgently needed new approach for treating metastatic [NSCLC]. There are few treatment options for people living with this aggressive cancer. In fact, the results from the phase 3 trial of [TTFields] were the first in more than 8 years to show a treatment providing a significant extension in [OS],” trial investigator Joachim Aerts, MD, a professor of Pulmonary Oncology at Erasmus MC Cancer Institute, stated in the press release.¹ “These results and the lack of systemic toxicity observed with [TTFields] provide patients with a promising new treatment option.”

In the prospective phase 3 LUNAR study, patients were randomly assigned to receive TTFields 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 regular daily routine.²

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

The FDA previously approved TTFields plus docetaxel or ICIs for patients with metastatic NSCLC in October 2024 based on findings from the LUNAR trial.³

“[TTFields] therapy has demonstrated effectiveness in multiple tumor types that have historically been very difficult to treat, including lung cancer. We believe the efficacy [TTFields] can offer, paired with its lack of systemic toxicity, has the potential to change the way late-stage lung cancer is treated,” Frank Leonard, president at Novocure Oncology, concluded.¹

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 22, 2025. https://tinyurl.com/27y8a3rt
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 22, 2025. https://tinyurl.com/2suast7c
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 22, 2025. https://tinyurl.com/3ep6e78e