On August 29, 2023 Novocure (NASDAQ: NVCR) reported that data from the randomized phase 3 LUNAR clinical trial evaluating the use of Tumor Treating Fields (TTFields) therapy together with standard systemic therapies for the treatment of metastatic non-small cell lung cancer (NSCLC) following progression on or after platinum-based therapy have been published in The Lancet Oncology (Press release, NovoCure, AUG 29, 2023, View Source [SID1234634769]).

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As presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, the LUNAR trial met its primary endpoint, showing a statistically significant and clinically meaningful 3-month improvement in median overall survival (OS) when TTFields therapy was added to physician’s choice of immune checkpoint inhibitor (ICI) or docetaxel (HR: 0.74, P=0.035). The data demonstrate the efficacy and safety of TTFields therapy in this setting, with no systemic toxicities or new safety signals. In addition, patient-reported data suggest there was no quality-of-life burden associated with adding TTFields therapy to standard therapy.

"The results of the LUNAR trial support the use of Tumor Treating Fields therapy in metastatic NSCLC in the second line and beyond," said primary investigator Ticiana Leal, M.D., a researcher and medical oncologist at Winship Cancer Institute of Emory University and associate professor and director of the Thoracic Medical Oncology Program in the Department of Hematology and Medical Oncology at Emory University School of Medicine in Atlanta. "This is a promising development for a population of patients with limited treatment options. The results suggest that Tumor Treating Fields therapy can safely be used along with standard systemic therapies to extend survival without reducing quality of life."

Patients randomized to receive TTFields therapy together with standard therapies (n=137) demonstrated median OS of 13.2 months compared to 9.9 months in patients treated with standard therapies alone (n=139). Patients randomized to receive TTFields therapy and physician’s choice ICI (n=66) demonstrated a median OS of 18.5 months versus a median OS of 10.8 months in patients treated with an ICI alone (n=68; HR=0.63; P=0.03). Patients randomized to receive TTFields therapy and docetaxel (n=71) had a positive survival trend with a median OS of 11.1 months vs 8.7 months in patients treated with docetaxel alone (n=71). TTFields therapy was well-tolerated with no added systemic toxicities and few grade 3 (no grade 4 or 5) device-related adverse events.

"We are pleased the LUNAR trial results have been published in The Lancet Oncology, one of the most influential medical journals in the field of cancer research," said William Doyle, Novocure’s Executive Chairman. "The LUNAR data demonstrate the benefit of TTFields therapy for patients with metastatic non-small cell lung cancer. We are eager to make our therapy available to this patient population with high unmet needs, and we are confident TTFields therapy has a place in current and future standards of care."

The LUNAR clinical trial data are expected to serve as the basis for a Premarket Approval (PMA) submission to the U.S. Food and Drug Administration in the second half of 2023. Novocure recently completed the LUNAR submission for CE mark.

Read the full article in the latest issue of The Lancet Oncology.

About LUNAR

LUNAR was a phase 3 trial testing the safety and effectiveness of TTFields therapy when used together with ICI or docetaxel (experimental arm) versus ICI or docetaxel alone (control arm) for patients with metastatic NSCLC who progressed during or after platinum-based therapy. It is estimated that approximately 46,000 patients receive second-line treatment for metastatic NSCLC each year in the U.S. The primary endpoint was superior overall survival of patients treated with TTFields therapy plus ICI or docetaxel versus ICI or docetaxel alone. The powered secondary endpoints were superior overall survival of patients treated with TTFields therapy plus ICI versus ICI cohort and superior overall survival of patients treated with TTFields therapy plus docetaxel versus docetaxel alone. TTFields therapy is intended principally for use with other concomitant standard therapies, and LUNAR was designed to generate data that contemplates multiple outcomes, all of which Novocure believes will be clinically meaningful.

About NSCLC

Lung cancer is the most common cause of cancer-related death worldwide, and NSCLC accounts for approximately 85% of all lung cancers. It is estimated that approximately 193,000 patients are diagnosed with NSCLC each year in the U.S. Physicians use different combinations of surgery, radiation and pharmacological therapies to treat NSCLC, depending on the stage of the disease. Surgery, which may be curative in a subset of patients, is usually used in early stages of the disease. Since 1991, radiation with a combination of platinum-based chemotherapy drugs has been the first-line standard of care for locally advanced or metastatic NSCLC. Certain immune checkpoint inhibitors have been approved for the first-line treatment of NSCLC and the standard of care in this setting appears to be evolving rapidly. The standard of care for second-line treatment is also evolving and may include platinum-based chemotherapy for patients who received immune checkpoint inhibitors as their first-line regimen, docetaxel, immune checkpoint inhibitors or pemetrexed.