Novocure Announces The Lancet Oncology Publishes Primary Data from Phase 3 LUNAR Clinical Trial in Patients with Metastatic Non-Small Cell Lung Cancer After Platinum-Based Therapies

Rhea-AI Summary

Novocure's LUNAR trial shows significant improvement in overall survival for metastatic NSCLC patients with the use of TTFields therapy, with potential for FDA approval.

Positive

• The LUNAR trial demonstrated a statistically significant and clinically meaningful 3-month improvement in median overall survival (OS) when TTFields therapy was added to standard systemic therapies.
• Patients treated with TTFields therapy together with standard therapies showed a median OS of 13.2 months compared to 9.9 months for patients treated with standard therapies alone.
• TTFields therapy was well-tolerated with no added systemic toxicities and few adverse events.

Negative

• None.

ROOT, Switzerland--(BUSINESS WIRE)-- Novocure (NASDAQ: NVCR) announced today 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.

As presented at the 2023 American Society of Clinical Oncology 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.

About Novocure

Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma, malignant pleural mesothelioma and pleural mesothelioma. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer.

Headquartered in Root, Switzerland and with a growing global footprint, Novocure has regional operating centers in Portsmouth, New Hampshire and Tokyo, as well as a research center in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and Twitter.

Forward-Looking Statements

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical trial progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions as well as issues arising from the COVID-19 pandemic and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 23, 2023, and subsequent filings with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

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Source: Novocure