Novocure Enrolls First Patient in KEYNOTE-B36, a Pilot Study of Tumor Treating Fields Together with KEYTRUDA® for Patients with First-Line Stage III Non-Small Cell Lung Cancer

Rhea-AI Summary

Novocure (NASDAQ: NVCR) has enrolled its first patient in the phase 2 KEYNOTE-B36 study, conducted with MSD, to evaluate Tumor Treating Fields (TTFields) alongside KEYTRUDA® for treating advanced non-small cell lung cancer (NSCLC). The study aims to enroll 66 patients and will assess the objective response rate as its primary endpoint, with secondary endpoints including overall survival and adverse event frequency. Lung cancer is the leading cause of cancer death globally, with NSCLC comprising 85% of cases. Novocure's TTFields technology aims to enhance standard cancer therapies.

Positive

• Enrollment of first patient in phase 2 KEYNOTE-B36 study highlights progress in clinical research.
• Collaboration with MSD may strengthen therapeutic development and patient outreach.
• Potential to improve treatment options for advanced NSCLC patients, an area with substantial unmet need.

Negative

• Phase 2 study results are uncertain; effectiveness and safety of TTFields with KEYTRUDA still need validation.
• -

ST. HELIER, Jersey--(BUSINESS WIRE)-- Novocure (NASDAQ: NVCR) today announced the first patient has been enrolled in its phase 2 pilot KEYNOTE-B36 study, conducted in collaboration with MSD, a tradename of Merck & Co., Inc., Rahway, NJ, USA. KEYNOTE-B36 is designed to evaluate the safety and effectiveness of Tumor Treating Fields (TTFields) together with KEYTRUDA^® (pembrolizumab), MSD’s anti-PD-1 therapy, for the first-line treatment of locally advanced or metastatic intrathoracic non-small cell lung cancer (NSCLC) that expresses PD-L1.

“This is an important next step for our thoracic program,” said William Doyle, Novocure’s Executive Chairman. “KEYNOTE-B36 represents one of Novocure’s five ongoing clinical trials exploring the potential of Tumor Treating Fields to complement immunotherapy agents. We look forward to continuing our studies in partnership with Merck in hopes of treating many more patients in need.”

KEYNOTE-B36 is a single arm, open-label phase 2 pilot study expected to enroll 66 patients. The primary endpoint of the study is objective response rate. Secondary endpoints include overall survival, progression free survival (PFS), PFS at six months, one-year survival rate, duration of response, disease control rate and frequency and severity of adverse events.

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.

About Tumor Treating Fields
Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division. Fundamental scientific research extends across more than two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. TTFields therapy 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 therapy has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, including four phase 3 pivotal trials in a variety of tumor types. To date, more than 24,000 patients have been treated with TTFields therapy.

The NovoTTF-200T is an investigational device for the treatment of NSCLC. Safety and efficacy have not been established for this indication.

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 and in the U.S. for the treatment of adult patients with malignant 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 Jersey, and with a growing global footprint, Novocure has regional operating centers in Root, Switzerland, 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.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

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 24, 2022 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/20220621005374/en/

Investors:

Ingrid Goldberg

investorinfo@novocure.com

610-723-7427



Media:

Leigh Labrie

media@novocure.com

610-723-7428

Source: Novocure

FAQ

What is the KEYNOTE-B36 study involving NVCR?

The KEYNOTE-B36 study is a phase 2 pilot trial evaluating Tumor Treating Fields (TTFields) in combination with KEYTRUDA® for treating advanced non-small cell lung cancer.

How many patients will be enrolled in the KEYNOTE-B36 study?

The KEYNOTE-B36 study is expected to enroll 66 patients.

What is the primary endpoint of the KEYNOTE-B36 study?

The primary endpoint is the objective response rate.

What cancer type is being targeted by Novocure's KEYNOTE-B36 study?

The study targets locally advanced or metastatic intrathoracic non-small cell lung cancer (NSCLC) that expresses PD-L1.

When was the first patient enrolled in the KEYNOTE-B36 study?

The first patient was enrolled today, marking a significant milestone for Novocure.