Novocure and MSD Announce Clinical Collaboration to Evaluate Tumor Treating Fields Combined with KEYTRUDA in First-Line PD-L1-Positive Non-Small Cell Lung Cancer

Novocure Announces Clinical Trial Collaboration with MSD to Combine Tumor Treating Fields with Keytruda for the Treatment of Non-Small Cell Lung Cancer (NSCLC)Novocure, Inc. announced today that it has entered into a clinical trial collaboration agreement with MSD to combine Tumor Treating Fields with MSD’s blockbuster anti-PD-1 therapy, Keytruda, for the treatment of patients with non-small cell lung cancer (NSCLC). Novocure’s Tumor Treating Fields utilize electric fields tuned to specific frequencies to disrupt cell division, inhibit tumor growth, and induce cancer cell death.

Lung cancer is one of the leading causes of cancer-related deaths worldwide, with the annual number of lung cancer deaths exceeding the combined total of those from colorectal and breast cancers. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for approximately 85% of all cases. The five-year survival rate for patients diagnosed with non-small cell lung cancer in the United States is approximately 24%.

Tumor Treating Fields, developed by Novocure, utilize electric fields modulated to specific frequencies to disrupt the normal movement of polar molecules within cells that are required to relocate to specific positions during cell division. This disruption impairs cell division and inhibits tumor growth. Tumor Treating Fields do not stimulate or heat tissues and cause minimal damage to healthy cells; mild to moderate skin irritation is the most commonly reported adverse effect. Tumor Treating Fields have been approved in certain countries for the treatment of adult patients with glioblastoma and are approved in the United States for the treatment of mesothelioma.

▲ Mechanism of Action of Tumor Treating Fields (Image source: Novocure official website)

In 2018, Zai Lab entered into an agreement with Novocure to obtain exclusive licensing rights for Tumor Treating Fields in the Greater China region. Optune, an innovative product based on Tumor Treating Fields, was granted Innovative Medical Device Designation by China’s National Medical Products Administration (NMPA) last year for the treatment of adult patients (aged 22 years or older) with glioblastoma (GBM).

Under the agreement, Novocure and Merck Sharp & Dohme (MSD) plan to conduct a Phase 2 pilot clinical study evaluating the combination of Tumor Treating Fields with Keytruda as first-line treatment for patients with advanced or metastatic PD-L1-positive non-small cell lung cancer (NSCLC) with intrathoracic disease. The study is designed to enroll approximately 66 patients and is expected to commence in the second half of 2020. The primary endpoint is objective response rate (ORR). Secondary endpoints include overall survival, progression-free survival (PFS), PFS rate at 6 months, 1-year survival rate, duration of response, disease control rate at 18 weeks, and safety.

“We are very pleased to partner with MSD to extend the lives of patients with the most aggressive tumors through the development and promotion of Tumor Treating Fields,” said William Doyle, Executive Chairman of Novocure. “Multiple preclinical studies have demonstrated that combining Tumor Treating Fields with anti-PD-1 therapy has the potential to enhance immune responses, thereby improving tumor control. We look forward to generating clinical data demonstrating the efficacy of combining Tumor Treating Fields with Keytruda as a first-line treatment for NSCLC.”

References:

[1] Novocure Announces Clinical Trial Collaboration with MSD to Evaluate Tumor Treating Fields Together with KEYTRUDA® (pembrolizumab) in Non-Small Cell Lung Cancerhttps://www.businesswire.com/news/home/20200715005430/en

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