Switzerland – Novocure (NASDAQ: NVCR) today presents positive results from the Phase 3 LUNAR clinical trial evaluating the use of TTFields (Tumor Treating Fields) therapy alongside standard therapies for the treatment of non-small cell lung cancer (NSCLC) at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO).
The LUNAR study met its primary endpoint with a statistically significant and clinically meaningful 3-month improvement in median overall survival (OS) when TTFields therapy was added to standard of care therapies (HR: 0.74, P=0.035).
Patients randomized to receive TTFields therapy with standard therapies (n=137) had a median OS of 13.2 months compared to 9.9 months in patients treated with standard therapies alone (n=139). A clear OS benefit from TTFields therapy was demonstrated in the immune checkpoint inhibitor (ICI) subgroup. Patients randomized to receive TTFields therapy and physician’s choice of ICIs (n=66) had a median OS of 18.5 months versus a median OS of 10.8 months in patients treated with ICIs alone (n= 68 HR=0.63 P=0.03). Patients randomized to receive TTFields therapy and docetaxel (n=71) showed a positive survival trend with a mean OS of 11.1 months versus 8.7 months in patients treated with docetaxel alone (n=71). TTFields therapy was well tolerated with no additional systemic toxicities and few grade 3 (no grade 4 or 5) device-related adverse events.
“The results of the LUNAR study are extremely encouraging,” said principal investigator Ticiana Leal, MD, a researcher and medical oncologist at Emory University’s Winship Cancer Institute and associate professor and director of the Thoracic Medical Oncology Program in the Department of Hematology and Medical Oncology from the Emory University School of Medicine in Atlanta. “The LUNAR study is the first study in more than seven years to demonstrate a significant improvement in overall survival in metastatic non-small cell lung cancer after platinum chemotherapy.” “I am encouraged by this progress and the potential of this innovative therapy to benefit many patients metastatic lung cancer that, after platinum therapy, requires new treatment options without added systemic toxicity.”
Baseline characteristics were well balanced between cohorts: median age was 64 years (range 22-86); 65% male; 96% of patients had an ECOG performance status of 0-1. Patients were enrolled at sites in North America (30%), Western Europe (30%), Eastern Europe (30%) and East Asia (9%). The one-year survival rate for patients treated with TTFields therapy along with standard therapies was 53% versus 42% for patients treated with standard therapies alone (P=0.04). A landmark three-year survival analysis for patients treated with TTFields therapy along with standard therapies showed an almost three-fold improvement, 18% versus 7% in patients treated with standard therapies alone (P=0.015). Median progression-free survival (PFS) for patients treated with TTFields therapy plus standard therapies was 4.8 months versus 4.1 months for patients treated with standard therapies alone.
Of the randomized patients, 89% had received prior systemic therapy and 31% of the randomized patients had been treated with an ICI (58% of the patients were randomized to the docetaxel cohort and 2% of the patients were randomized to the ICI cohort). ICIs were approved for the first-line treatment of NSCLC in 2017 during the conduct of the LUNAR study and subsequently data on PD-L1 expression were collected in geographic regions where ICIs were introduced. Tumor proportion scores were available for 151 patients worldwide (55%) and were well balanced across all cohorts. In all patients treated with ICI and tumor proportion scores measured, 63% had >1% PD-L1 expression, consistent with real-world data. PD-L1 expression data was collected from 83% of patients enrolled at US sites (69 of 83 patients) and was well balanced across the four cohorts.
Novocure has submitted the results of the LUNAR clinical study for publication in a leading peer-reviewed medical journal. Data from the LUNAR clinical study is expected to serve as the basis for a Premarket Approval (PMA) filing with the U.S. Food and Drug Administration in the second half of 2023.
“I would like to thank our patients, their families and caregivers for participating in the LUNAR study,” said William Doyle, Executive Chairman of Novocure. “Also, I would like Dr. Leal and all of our investigators for their expertise and dedication to improving patient care.” The results of the LUNAR study represent a tremendous advance for the treatment of metastatic non-small cell lung cancer, and the LUNAR study demonstrates the broad and diverse potential of TTFields – Therapy to improve survival in cancer patients with high unmet needs. “We are excited by the LUNAR results and are working expeditiously to bring TTFields therapy to patients with metastatic non-small cell lung cancer.”
Novocure is dedicated to advancing TTFields therapy for patients with solid tumors. The LUNAR clinical trial is the first of four Phase 3 clinical trials, expected to be completed by the end of 2024, evaluating the use of TTFields therapy to treat solid tumors of the brain, trunk and abdomen. Based on the strength of the LUNAR data, Novocure intends to initiate additional Phase 3 studies evaluating TTFields therapy in previous lines of treatment and alongside ICIs and other standards of care.
INVESTOR EVENT DETAILS
Novocure will host an investor event on Tuesday, June 6, 2023 at 2:00 p.m. CDT. The event will include a presentation and discussion of data from the LUNAR clinical trial with leading thoracic oncologists, researchers and Novocure leadership. A live webcast of the event will be available on the Investor Relations page of www.novocure.com.
OVER MOON
LUNAR is a phase 3 study evaluating the safety and efficacy of TTFields therapy when used concomitantly with ICI or docetaxel (experimental arm) versus ICI or docetaxel alone (control arm) in patients with metastatic NSCLC who progression has occurred during or after platinum-based therapy. It is estimated that approximately 46,000 patients receive second-line treatment for metastatic NSCLC in the United States each year. The primary endpoint is better overall survival for patients treated with TTFields therapy plus ICI or docetaxel compared to ICI or docetaxel alone. The meaningful secondary endpoints are better overall survival for patients treated with TTFields therapy plus ICI compared to the ICI cohort and better overall survival for patients treated with TTFields therapy plus docetaxel compared to docetaxel alone. TTFields therapy is primarily intended for use with other standard concomitant treatments, and LUNAR was designed to generate data incorporating multiple outcomes, all of which Novocure believes will be clinically meaningful.
ABOUT NSCLC
Lung cancer is the leading cause of cancer-related deaths worldwide, and NSCLC accounts for approximately 85% of all lung cancers. It is estimated that approximately 193,000 patients are diagnosed with NSCLC in the United States each year. Doctors use different combinations of surgery, radiation, and pharmacological therapies to treat NSCLC, depending on the stage of the disease. Surgery, which can be curative in a subset of patients, is usually used in the early stages of the disease. Since 1991, irradiation with a combination of platinum-based chemotherapeutic agents has been the standard of first-line treatment for locally advanced or metastatic NSCLC. Certain immune checkpoint inhibitors have been approved for the frontline 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, pemetrexed, docetaxel, or immune checkpoint inhibitors as first-line therapy.
ABOUT NOVOCURE
Novocure is a global oncology company working to improve survival in some of the most aggressive types 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 is conducting ongoing or completed clinical studies investigating tumor treatment areas in brain metastasis, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer.
Headquartered in Root, Switzerland, Novocure has a growing global footprint, with regional operations centers in Portsmouth, New Hampshire and Tokyo, and a research center in Haifa, Israel.
FORWARD LOOKING STATEMENTS
In addition to historical facts or statements of current status, this press release may contain forward-looking statements. Forward-looking statements represent Novocure’s current expectations or projections of future events. This may include statements regarding anticipated scientific progress of its research programs, clinical trial progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capability, market prospects for its products, coverage and collections from third parties include payers and other statements relating to matters that are not historical facts. You can identify some of these forward-looking statements by the statements’ use of words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” or other words and similar expressions Meaning. Novocure’s performance and financial results could differ materially from those due to general financial, economic, environmental, regulatory and political conditions, as well as issues related to the COVID-19 pandemic and other more specific risks and uncertainties Novocure faces reflected in these forward-looking statements, such as those set forth in its annual report on Form 10-K filed on February 23, 2023 and subsequent filings with the Securities and Exchange Commission. Given these risks and uncertainties, some or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on such factors or any forward-looking statements. Additionally, Novocure does not intend to publicly update any forward-looking statements, except as required by law. Any forward-looking statements contained herein speak only as of the date of this release. The Private Securities Litigation Reform Act of 1995 allows for this discussion.
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