Tumor treating fields plus standard-of-care therapies led to a statistically significant and clinically meaningful improvement in overall survival vs SOC alone in patients with stage IV NSCLC who progressed while on or after platinum chemotherapy, meeting the primary end point of the LUNAR trial.
Treatment with tumor treating fields (TTFields) plus standard-of-care (SOC) therapies demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) vs SOC alone in patients with stage IV non–small cell lung cancer (NSCLC) who progressed while on or after treatment with platinum-based chemotherapy, meeting the primary end point of the phase 3 LUNAR trial (NCT02973789).1
Findings showed that patients treated with TTFields plus immune checkpoint inhibitors experienced a statistically significant and clinically meaningful improvement in OS compared with those given immune checkpoint inhibitors alone. Additionally, a positive trend in OS was observed for patients treated with TTFields plus docetaxel compared with docetaxel alone.
Full results of LUNAR will be presented at a future medical conference. Novocure expects to file a premarket approval application with the FDA in the second half of 2023.
“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 OS in late-stage, platinum-resistant NSCLC was six years ago, underlining the difficulty in treating this disease,” William Doyle, executive chairman of Novocure, stated 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,” Doyle continued. “I would like to thank our patients and investigators for their courage and dedication in completing LUNAR. And, I would like to thank Novocure’s employees for their unrelenting commitment to patients and their perseverance in propelling Novocure to this major milestone.”
TTFields are electric fields that exert physical forces to kill cancer cells through a variety of mechanisms. Because healthy cells have different properties from cancer cells, such as division rate, morphology, and electrical properties, TTFields do not significantly affect healthy cells.
TTFields work to selectively target and kill cancer cells, and due to its multiple mechanistic actions, TTFields can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or PARP inhibition in preclinical models.
LUNAR enrolled patients aged 22 years of age or older with a histological diagnosis of squamous or nonsquamous, inoperable, metastatic NSCLC who progressed on or after platinum-based chemotherapy.2 Patients were also required to have an ECOG performance status of 0 to 2, a life expectancy of at least 3 months, and be assigned by a physician to receive either docetaxel or immune checkpoint inhibitor per SOC.
Patients with central nervous system (CNS) metastases with clinical symptoms or evidence of new CNS metastases were deemed ineligible. Select patients with previously treated, stable CNS metastases were permitted to enroll if they neurologically returned to baseline, had no treatment for CNS metastases during the screening period, had no progress in CNS lesions as indicated by MRI within 14 days prior to randomization, and had no meningeal metastasis or spinal cord compression.
Other key exclusion criteria included contraindications to immunotherapy or docetaxel, severe comorbidities, or concurrent experimental treatment for NSCLC.
Patients were randomly assigned to receive SOC with immune checkpoint inhibitors or docetaxel with or without TTFields. Patient enrollment was well balanced between the immune checkpoint inhibitor and docetaxel cohorts of the experimental and control arms, and control arms performed in line with prior studies.
Along with the primary end point of OS, secondary end points included OS for patients treated with TTFields plus docetaxel vs docetaxel alone, OS for patients treated with TTFields plus immune checkpoint inhibitors vs immune checkpoint inhibitors alone, OS for patients treated with TTFields plus docetaxel vs immune checkpoint inhibitors alone, progression-free survival, overall radiological response rate, quality of life, and safety.
TTFields therapy was well tolerated by patients enrolled in the experimental arm of the study.