Presentations include new post-hoc analysis of data from phase 3 LUNAR trial in metastatic non-small cell lung cancer

Novocure (NASDAQ: NVCR) today announced its participation in the upcoming International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer (WCLC) from September 9 – 13, 2023 in Singapore. Novocure will take part in presentations and symposia throughout the event and will exhibit several posters exploring the use of Tumor Treating Fields (TTFields) therapy in the treatment of lung cancer, including a new post-hoc analysis of data from its LUNAR trial in metastatic non-small cell lung cancer.

The LUNAR trial was designed to evaluate the use of TTFields therapy together with standard systemic therapies for the treatment of metastatic non-small cell lung cancer, following progression on or after platinum-based therapy. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful extension in overall survival (OS) for patients treated with TTFields and standard systemic therapies, as well as a pronounced extension in OS for patients randomized to receive physician’s choice immune checkpoint inhibitor (ICI) together with TTFields.

In a new post-hoc analysis of data from the LUNAR trial, researchers reviewed survival patterns of patients with known Tumor Proportion Scores (TPS) randomized to receive ICI together with or without TTFields. Among patients with TPS >1%, median OS for patients treated with TTFields therapy and ICI (n=22) was 23.6 months compared to 10.5 months for patients treated with ICI alone (n=26; HR: 0.49, P=0.045).

Further analysis shows evidence of a relationship between increasing PD-L1 expression and improved survival outcomes. In patients with TPS 1–49%, median OS was 19.0 months for patients treated with TTFields therapy and ICI (n=17), compared to 9.7 months for patients treated with ICI alone (n=18; HR: 0.55, P=0.14). In patients with TPS >50%, median OS was not reached for patients treated with TTFields therapy and ICI (n=5) compared to 30.0 months for patients treated with ICI alone (n=8; HR: 0.17, P=0.07).

These data will be presented on September 12, 2023 at 2:30 p.m. UTC+8 by 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 analysis further elucidates the promising results from the LUNAR trial and the potential benefit of utilizing TTFields therapy for the treatment of metastatic non-small cell lung cancer,” Dr. Leal said. “I look forward to sharing these data with the global thoracic oncology community and continuing to analyze the data from this impactful study.”

Novocure’s presence at the 2023 WCLC will also include:

• An Industry Sponsored Symposium: A Spotlight on Tumor Treating Fields in Thoracic Oncology, on September 10 at 6:30 p.m. UTC+8
  
  
• A poster displayed in the Exhibit Hall on September 10 from 5:30-7:30 p.m. UTC+8: P1.12-10 – Sensitization of Cancer Cells to Tumor Treating Fields (TTFields) via Inhibition of the PI3K/AKT Signaling Pathway
  
  
• Three ePosters on demand:
  • EP02.02-02 – Transcriptomic Response to Tumor Treating Fields (TTFields) Across Tumor Types
  • EP09.02-06 – Long-term Efficacy of Tumor Treating Fields (TTFields 150 kHz) in metastatic NSCLC: A Case Report
  • EP17.03-02 – Utilities Used in HTAs in mNSCLC Following Progression on or After Platinum-Based Chemotherapy

In addition, Novocure is partnering with the IASLC, host of the WCLC, to provide research opportunities to investigators worldwide who are conducting innovative research on TTFields in the treatment of non-small cell lung cancer and other thoracic malignancies. These grants offer $100,000 to fund projects to be completed in a two-year timeframe.

“We are honored to partner with the IASLC in their mission to study and eradicate lung cancer and other thoracic malignancies,” said Moshe Giladi, Ph.D., Novocure’s Chief Science Officer. “We look forward to supporting researchers and together expanding understanding of how TTFields therapy can be beneficial in the treatment of these diseases.”

To learn more about these grants, please visit https://iaslc.secure-platform.com/researchgrants/page/Grant_Guidelines/Partner_Grants/IASLC_Novocure_Grants.The application deadline is noon MDT on October 9, 2023.

About LUNAR

LUNAR was a phase 3 trial testing the safety and effectiveness of TTFields therapy when used together with ICI or docetaxel versus ICI or docetaxel alone for patients with metastatic NSCLC who progressed during or after platinum-based therapy. The trial met its primary endpoint, exhibiting a statistically significant and clinically meaningful improvement in median OS when TTFields therapy was added to standard therapies. 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; HR: 0.74, P=0.035).

The trial also demonstrated a statistically significant and clinically meaningful improvement in median OS when TTFields therapy was added to ICI. 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 ICIs 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.

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. It is estimated that approximately 46,000 patients receive second-line treatment for metastatic NSCLC each year in the U.S.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230908394524/en/