FDA Grants Premarket Approval to TTFields in NSCLC

Lung with cancer cells: © catalin - stock.adobe.com

• The FDA has accepted the premarket approval (PMA) application of tumor treating fields (TTFields) plus standard systemic therapies for the treatment of non–small cell lung cancer (NSCLC).
• The application is now under substantive FDA review.
• A complete regulatory decision is expected in the second half of 2024.

The PMA application for TTFields plus standard-of-care (SOC) in NSCLC following disease progression with platinum-based therapy has been accepted by the FDA, according to Novocure.¹

The application is now under substantive review, and the FDA is expected to deliver a regulatory decision in the second half of 2024.

TTFields are mild electrical fields that can interrupt cancer cells’ ability to divide in solid tumors. The FDA approved the first TTFields device in 2011 for the treatment of certain tumors, including glioblastoma multiforme.²

“We are thrilled to announce the FDA has accepted our PMA application for review of the LUNAR data in NSCLC,” said Asaf Danziger, chief executive officer of Novocure, 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.”

Findings from the phase 3 LUNAR study (NCT02973789) support this application. In the study, investigators combined TTFields therapy with an immune checkpoint inhibitor (ICI) or docetaxel for the treatment of patients with NSCLC who experienced disease progression following platinum-based therapy. Patients who received TTFields plus SOC (n = 137) had a median overall survival (OS) of 13.2 months vs 9.9 months among patients treated with SOC alone (n = 139).

Combining TTFields and physician’s choice ICI demonstrated a median OS of 18.5 months (n = 66; 95% CI, 10.6-30.3) vs 10.8 months (95% CI, 8.2-17.6) in patients who received an ICI alone (n = 68; HR, 0.63; P=.03). Patients who received treatment with TTFields plus docetaxel (n = 71) showed a median OS of 11.1 months (95% CI, 8.2-14.1) compared with 8.7 months (95% CI, 6.5-12.2) in patients who only received docetaxel (n = 71).¹

Regarding safety, no additional systemic toxicities were associated with TTFields, and no grade 4 or 5 device-related adverse events were observed.

Patients in the LUNAR study must have been 22 years of age or older with a life expectancy of 3 months or longer. Patients also needed to have an ECOG performance status of 0-2 and able to operate the TTFields device alone or with the help of a caregiver. Those with central nervous system metastases, severe comorbidities, or implantable electronic medical devices were not eligible for enrollment.³

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 18, 2024. http://tinyurl.com/5775yttt

2. TT Fields (Tumor Treating Fields) for brain tumors. Johns Hopkins Medicine. Accessed January 18, 2024. http://tinyurl.com/55myrs7s 

3. Effect of Tumor Treating Fields (TTFields) (150 kHz) concurrent with standard of care therpaies for treatment of stage 4 non–small cell lung cancer (NSCLC) following platinum failure. ClinicalTrials.gov. Updated September 28, 2023. Accessed January 18, 2024. https://clinicaltrials.gov/study/NCT02973789