TTFields Plus SOC Provides Survival Advantage for Patients With Stage IV NSCLC

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The primary end point of overall survival improvement has been reached in the phase 3 LUNAR study, which is evaluating Tumor Treating Fields in combination with standard therapies for the treatment of stage IV non–small cell lung cancer.

A statistically significant overall survival (OS) improvement resulted from treatment with Tumor Treating Fields (TTFields) in combination with standard therapies, in patients with stage IV non–small cell lung cancer (NSCLC) who previously progressed on platinum-based chemotherapy. This finding is from the phase 3 LUNAR clinical trial (NCT02973789).1

Investigators also found that in patients with NSCLC who received TTFields combined with immune checkpoint inhibitor (ICI) therapy, there was a statistically significant and clinically meaningful OS improvement compared with those who were treated with ICIs alone. There was also a trend toward OS improvement among patients with NSCLC who received TTFields in combination with docetaxel vs those treated with docetaxel alone.

“We are pleased with the positive readout of the LUNAR study. Prior to LUNAR, the last phase 3 trial to lead to significant improvement in overall survival in late-stage, platinum-resistant non-small cell lung cancer was 6 years ago, underlining the difficulty in treating this disease,” said William Doyle, executive chairman of Novocure, in a press release. “We are also pleased by the profound performance of the TTFields together with immunotherapy, which has the potential to meaningfully extend patient survival beyond what was previously possible.”

LUNAR is a pivotal, randomized, open-label stud of 276 patients. Patients are required to be at least 22 years of age with a life expectancy of at least 3 months, a histological diagnosis of squamous or non-squamous, in-operable, metastatic NSCLC, a diagnosis of radiographic progression on platinum-based therapy, and an ECOG performance status of 0 to 2. Those enrolled are being treated at 124 locations across North America, Europe, and Asia.2

Patients are being evaluated for the primary end point of OS and the secondary end points of OS, progression-free survival (PFS), overall radiographic response rate, quality of life, effects of the study drugs, effects of treatment compliance of OS and PFS, and the severity and frequency of adverse events.

Full results from the LUNAR study will be presented at a future medical meeting. The developer, Novocure, also plans to file a premarket approval application with the FDA in the second half of 2023. A CE Mark application will also be filed with the European Commission.1

REFERENCES:

1. Novocure announces pivotal LUNAR study in non-small cell lung cancer met primary overall survival endpoint. News release. Novocure. January 5, 2023. Accessed January 5, 2023. https://bit.ly/3CqTc7F

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 12, 2022 Accessed January 5, 2023. https://clinicaltrials.gov/ct2/show/NCT02973789

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