FDA Accepts Premarket Approval Application for Tumor Treating Fields Therapy for Non-Small Cell Lung Cancer

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The FDA has accepted Novocure’s premarket approval (PMA) application for the addition of tumor-treating fields (TTFields) to standard-of-care (SOC) therapies in patients with non­–small cell lung cancer (NSCLC) following disease progression on or after platinum-based treatment.¹

Novocure’s PMA application, which was based on data from the Phase III LUNAR trial (NCT02973789), was submitted to the FDA with a filing date of December 15, 2023.

“We are thrilled to announce the FDA has accepted our PMA application for review of the LUNAR data in NSCLC,” said Novocure CEO Asaf Danziger in a press release.¹ “This significant milestone brings us one step closer to treating patients seeking treatment for NSCLC, post-platinum, for which very few effective non-toxic options exist today. I would like to thank our investigators and patients, as well as our Novocure colleagues, for their dedication in pursuit of bringing our novel therapy to thousands of patients in need.”

The LUNAR trial evaluated the safety and efficacy of TTFields therapy combined with either an immune checkpoint inhibitor (ICI) or docetaxel in patients with metastatic NSCLC following progression on or after the use of platinum-based therapy. Investigators enrolled patients aged 22 years and older with metastatic NSCLC whose disease progressed on or after platinum-based treatment. Patients were required to have an ECOG performance status ranging from 0 to 2.

Patients (n = 276) were randomly assigned 1:1 to either TTFields therapy at 150 kHz for at least 18 hours a day combined with standard-of-care (SOC) of investigator’s choice of ICI, or docetaxel or SOC monotherapy. Patients administered ICIs were given Keytruda (pembrolizumab), Opdivo (nivolumab), or Tecentriq (atezolizumab). The trial’s primary endpoint was overall survival (OS), with key secondary endpoints that included OS in the ICI- and docetaxel-treated subgroups, progression-free survival (PFS), overall response rate (ORR), PFS and OS by histology, quality of life, and safety.

Data from the LUNAR trial show TTFields therapy combined with standard therapy options (n = 137) resulted in a median overall survival (OS) of 13.2 months (95% CI, 10.3-15.5) compared with 9.9 months (95% CI, 8.1-11.5) with SOC monotherapy (n = 139), which represented a 26% decrease in the risk of death in the intention-to-treat (ITT) population (HR, 0.74; 95% CI, 0.56-0.98; P = .035).²

The one-year survival rate in the TTFields plus physician’s choice ICI cohort was 53% (95% CI, 44%-61%) and the three-year survival rate was 18% (95% CI, 11%-27%) compared with 42% (95% CI, 34%-50%) and 7% (95% CI, 2%-15%), respectively, in the SOC only cohort, which represents a 37% decrease in the risk of death (HR, 0.63; 95% CI, 0.41-0.96; P = .03).

Investigators noted a positive survival trend in patients administered TTFields with docetaxel (n = 71) at 11.1 months (95% CI, 8.2-14.1) compared with docetaxel monotherapy (n = 71) at 8.7 months (95% CI, 6.3-11.3) (HR, 0.81; 95% CI, 0.55-1.19; P = .28).

Further, the one-year survival rate in the TTFields/docetaxel cohort was 46% (95% CI, 33%-57%) compared with 38% (95% CI, 27%- 49%) in the docetaxel monotherapy cohort; whereas the three-year survival rate was 9% (95% CI, 3%-20%) in the TTFields/docetaxel cohort compared with 5% (95% CI, 0%-18%) in the docetaxel monotherapy cohort.²

Novocure said it expects a regulatory decision in the second half 2024.

References

1. Novocure announces FDA acceptance of the PMA application for TTFields therapy in non-small cell lung cancer. News release. Novocure. January 18, 2024. Accessed January 19, 2024. https://www.novocure.com/novocure-announces-fda-acceptance-of-the-pma-application-for-ttfields-therapy-in-non-small-cell-lung-cancer/

2. Leal T, Kotecha R, Ramlau R, et al. Tumor treating field (TTFields) therapy with standard of care (SOC) in metastatic non-small cell lung cancer (mNSCLC) following platinum failure randomized, phase 3 LUNAR study. J Clin Oncol. 2023;41(suppl 17):LBA9005. doi:10.1200/JCO.2023.41.17_suppl.LBA9005.