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FDA Accepts PMA Application Seeking Approval of TTFields Therapy in NSCLC for Filing

*January 2024*

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

The PMA was supported by data from the phase 3 LUNAR study (NCT02973789) in which TTFields therapy paired with standard therapeutic options (n = 137) resulted in a median overall survival (OS) of 13.2 months (95% CI, 10.3-15.5) vs 9.9 months (95% CI, 8.1-11.5) with SOC therapies alone (n = 139), translating to a 26% reduction in the risk of death in the intention-to-treat (ITT) population (HR, 0.74; 95% CI, 0.56-0.98; = .035).2 In the TTFields/SOC arm, the 1- and 3-year survival rates were 53% (95% CI, 44%-61%) and 18% (95% CI, 11%-27%), respectively; in the SOC-only arm, these rates were 42% (95% CI, 34%-50%) and 7% (95% CI, 2%-15%), respectively.

Those who received TTFields therapy combined with physician’s choice of immune checkpoint inhibition (ICI; 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) in those given ICI alone (n = 68), translating to a 37% reduction in the risk of death (HR, 0.63; 95% CI, 0.41-0.96; = .03). In the TTFields/ICI arm, the 1- and 3-year survival rates were 60% (95% CI, 47%-71%) and 27% (95% CI, 15%-42%), respectively; in the ICI-alone arm, these rates were 46% (95% CI, 33%-57%) and 9% (95% CI, 3%-21%), respectively.

Moreover, a positive survival trend was observed in those who received TTFields plus docetaxel (n = 71) vs those given docetaxel alone (n = 71), at 11.1 months (95% CI, 8.2-14.1) and 8.7 months (95% CI, 6.3-11.3), respectively (HR, 0.81; 95% CI, 0.55-1.19; = .28). The 1-yr survival rates in the TTFields/docetaxel arm were 46% (95% CI, 33%-57%) vs 38% (95% CI, 27%- 49%) in the docetaxel-alone arm; the respective 3-year survival rates were 9% (95% CI, 3%-20%) and 5% (95% CI, 0%-18%).

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

TTFields are electric fields that employ physical forces on electrically charged components in dividing cancer cells to produce an antimitotic effect.2 Downstream effects comprise cell stress–induced immunogenic cell death and prompting antitumor responses in the immune system. The therapy is locoregionally administered to the chest through a wearable medical device and adhesive bandages with hydrogel-covered biocompatible insulated ceramic discs. Read more.