FDA Approves Optune Lua for Metastatic NSCLC After Platinum-Based Chemotherapy

FDA

The FDA has approved Optune Lua for concurrent use with PD-1/PD-L1 inhibitors or docetaxel for the treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) whose disease has progressed on or after a platinum-based regimen.¹

The regulatory decision was supported by findings from the phase 3 LUNAR trial (NCT02973789), which showed that patients given Optune Lua concurrently with a PD-1/PD-L1 inhibitor or docetaxel (n = 145) achieved a median overall survival (OS) of 13.2 months (95% CI, 10.3-15.5) vs 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).

“There have been a number of important advances in first-line treatment for NSCLC, but this is an aggressive disease, and most patients will develop progression, with limited effective treatment options in second line and beyond,” Ticiana Leal, MD, associate professor and director of the Thoracic Oncology Program at the Winship Cancer Institute of Emory University School of Medicine and primary investigator of the LUNAR study, stated in a news release. “The OS results we observed with Optune Lua in the LUNAR study mark the first substantial improvement in more than 8 years in this patient population which, when combined with Optune Lua’s lack of systemic toxicity, make this a compelling development for many patients and their physicians who need better treatment options for this advanced disease.”

LUNAR was a randomized, open-label, pivotal phase 3 study conducted across 130 sites in 19 countries, where investigators enrolled patients at least 22 years of age with metastatic NSCLC that progressed on or after platinum-based chemotherapy.² Patients were allowed to have squamous or nonsquamous histology, and an ECOG performance status of 2 or less was required. Although prior treatment with a platinum-based regimen was required, there was no limit on prior lines of systemic therapy.

Patients were randomly assigned 1:1 to receive tumor treating fields (TTFields) in the form of Optune Lua in combination with investigator's choice of concurrent standard systemic therapy, or systemic therapy alone. Investigator's choice of therapy comprised nivolumab (Opdivo), pembrolizumab (Keytruda), atezolizumab (Tecentriq), or docetaxel. TTFields were given at 150 kHz continuously to the thoracic region with a target average of 18 hours per day of device usage.

OS in the intention-to-treat population served as the trial's primary end point.

Additional data published in Lancet Oncology showed that patients treated with Optune Lua plus an immune checkpoint inhibitor (n = 66) experienced a median OS of 18.5 months (95% CI, 10.6-30.3) compared with 10.8 months (95% CI, 8.2-18.4) for those given a checkpoint inhibitor alone (n = 68; HR, 0.63; 95% CI, 0.41-0.96; P = .030).

Patients treated with Optune Lua plus docetaxel (n = 71) had a median OS of 11.1 months (95% CI, 8.2-14.1) compared with 8.7 months (95% CI, 6.3-11.3) for those given docetaxel alone (HR, 0.81; 95% CI, 0.55-1.19; P = .28).

Regarding safety, device-related adverse effects (AEs) were reported in 63.1% of patients in the experimental arm.¹ Most of these AEs were low grade, and grade 3 skin toxicity that required a break from treatment occurred in 4% of patients. No grade 4/5 AEs related to Optune Lua were reported, and no patients experienced device-related AEs leading to death.

“Novocure is committed to extending survival in some of the most aggressive and difficult-to-treat cancers. The approval of Optune Lua brings a new and urgently needed option for people with metastatic NSCLC who have progressed while on or after platinum-based chemotherapy,” Asaf Danziger, chief executive officer of Novocure, stated in a news release. “We are grateful to the patients, caregivers, investigators, and health care providers who supported the clinical trials that led to this approval.”

References

1. FDA approves Novocure’s Optune Lua for the treatment of metastatic non-small cell lung cancer. News release. Novocure. October 15, 2024. Accessed October 15, 2024. https://www.novocure.com/fda-approves-novocures-optune-lua-for-the-treatment-of-metastatic-non-small-cell-lung-cancer/
2. 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