On June 21, 2022 Novocure (NASDAQ: NVCR) reported 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 (Press release, NovoCure, JUN 21, 2022, View Source [SID1234616152]). 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 .

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"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.