Novocure Announces FDA IDE Approval and Steering Committee for KEYNOTE-B36 Trial Evaluating Tumor Treating Fields Together with Pembrolizumab in Non-Small Cell Lung Cancer

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Novocure (NASDAQ: NVCR) today announced that the U.S. Food and Drug Administration (FDA) has approved its investigational device exemption (IDE) application to initiate the KEYNOTE-B36 trial, conducted in collaboration with MSD (Merck & Co., Inc., Kenilworth, NJ, USA). Novocure also announced the members of its scientific steering committee who will provide expert opinions and recommendations regarding enrollment strategies, country distribution, study timelines and other scientific topics. The KEYNOTE-B36 trial will evaluate Tumor Treating Fields (TTFields) together with pembrolizumab for first-line treatment of locally advanced or metastatic intrathoracic, PD-L1 positive non-small cell lung cancer (NSCLC).

KEYNOTE-B36 steering committee members include:

  • Corey Langer, M.D., director of thoracic oncology and professor of medicine at the Hospital of the University of Pennsylvania
  • Anne S. Tsao, M.D., professor and section chief of thoracic medical oncology and director of the mesothelioma program at The University of Texas MD Anderson Cancer Center
  • Vinicius Ernani, M.D., Senior Associate Consultant at Mayo Clinic
  • Rupesh Kotecha, M.D., radiation oncologist and chief of radiosurgery at Miami Cancer Institute

"In vivo data suggest that using TTFields together with anti-PD-1 therapy results in increased tumor response versus either therapy alone," said Asaf Danziger, Novocure's Chief Executive Officer. "We are honored to have such an esteemed group of key opinion leaders join the KEYNOTE-B36 steering committee as we look to translate our preclinical knowledge into clinical data demonstrating the effect of TTFields together with pembrolizumab in first-line NSCLC. With the FDA IDE approval, we are now working closely with trial sites, investigators and institutional review boards to open sites and enroll patients as quickly as possible."

About KEYNOTE-B36

KEYNOTE-B36 is a phase 2 pilot trial conducted in collaboration with MSD (Merck & Co., Inc., Kenilworth, NJ, USA). KEYNOTE-B36 will evaluate the effectiveness of TTFields together with pembrolizumab for first-line treatment of locally advanced or metastatic intrathoracic, PD-L1 positive NSCLC. Objective response rate (ORR) is the primary endpoint of the study. Secondary endpoints include overall survival, progression free survival (PFS), PFS at six months, one-year survival rate, duration of response, disease control rate at 18 weeks and safety. The study is designed to enroll approximately 66 patients in the United States.

About Non-small Cell Lung Cancer

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 therapy and systemic 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 has been the first-line standard of care for locally advanced NSCLC and systemic therapy alone for those with metastatic disease. Certain immune checkpoint inhibitors have recently 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, pemetrexed, docetaxel or immune checkpoint inhibitors.

Use of Tumor Treating Fields for the treatment of NSCLC is investigational only.

About Tumor Treating Fields

Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division.

When cancer develops, rapid and uncontrolled division of unhealthy cells occurs. Electrically charged proteins within the cell are critical for cell division, making the rapidly dividing cancer cells vulnerable to electrical interference. All cells are surrounded by a bilipid membrane, which separates the interior of the cell, or cytoplasm, from the space around it. This membrane prevents low frequency electric fields from entering the cell. TTFields, however, have a unique frequency range, between 100 to 500 kHz, enabling the electric fields to penetrate the cancer cell membrane. As healthy cells differ from cancer cells in their division rate, geometry and electric properties, the frequency of TTFields can be tuned to specifically affect the cancer cells while leaving healthy cells mostly unaffected.

Whether cells are healthy or cancerous, cell division, or mitosis, is the same. When mitosis starts, charged proteins within the cell, or microtubules, form the mitotic spindle. The spindle is built on electric interaction between its building blocks. During division, the mitotic spindle segregates the chromosomes, pulling them in opposite directions. As the daughter cells begin to form, electrically polarized molecules migrate towards the midline to make up the mitotic cleavage furrow. The furrow contracts and the two daughter cells separate. TTFields can interfere with these conditions. When TTFields are present in a dividing cancer cell, they cause the electrically charged proteins to align with the directional forces applied by the field, thus preventing the mitotic spindle from forming. Electrical forces also interrupt the migration of key proteins to the cell midline, disrupting the formation of the mitotic cleavage furrow. Interfering with these key processes disrupts mitosis and can lead to cell death.

TTFields is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields' broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect.

Fundamental scientific research extends across two decades and, in all preclinical research to date, TTFields has demonstrated a consistent anti-mitotic effect. The TTFields global development program includes a broad range of clinical trials across all phases, included four phase 3 pivotal trials in a variety of tumor types. To date, more than 18,000 patients have been treated with TTFields.

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. Tumor Treating Fields are electric fields that disrupt cancer cell division. Novocure's commercialized products are approved for the treatment of adult patients with glioblastoma and malignant pleural mesothelioma. Novocure has ongoing 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 Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania and New York City. Additionally, the company has offices in Germany, Switzerland, Japan and Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.

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 25, 2021 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.

Disclosures

Dr. Tsao receives compensation as a member of this steering committee and has received past compensation as an advisory board member for MSD. These financial relationships have been disclosed to MD Anderson's Conflict of Interest Committee in accordance with institutional policy. She also serves as principal investigator on two clinical trials sponsored by MSD.