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Novocure Announces Clinical Trial Collaboration with Roche

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Trial to Evaluate Tumor Treating Fields as Part of a Novel Combination for the First-line Treatment of Metastatic Pancreatic Cancer.

Novocure has entered into a clinical trial collaboration agreement with Roche, to develop Tumor Treating Fields (TTFields) together with Roche’s anti-PD-L1 therapy, atezolizumab, in metastatic pancreatic ductal adenocarcinoma (mPDAC).

Pancreatic ductal adenocarcinoma (PDAC) is the most common type of pancreatic cancer and accounts for 85%–95% of all solid pancreatic tumors. As a highly lethal malignancy, it is the seventh leading cause of cancer death worldwide and is responsible for more than 300,000 deaths per year. PDAC is highly resistant to current therapies, affording patients a 5-year overall survival rate of only 7.2%.

“We are pleased to collaborate with Roche, a global leader in oncology, to explore the efficacy of TTFields together with atezolizumab immunotherapy in pancreatic cancer,” said William Doyle, Novocure’s Executive Chairman. “The immune-shielded environment of the pancreas has proved challenging for immunotherapies alone to provide benefit. Our phase 2 pilot trial with Roche will study the ability of TTFields together with atezolizumab to improve clinical outcomes for patients with this deadly disease.”

The phase 2 study was designed to test the safety and efficacy of TTFields together with atezolizumab, gemcitabine and nab-paclitaxel as a first-line treatment for mPDAC. The study is designed to enroll approximately 75 patients in the EU and United States. The primary endpoint of the study is disease control rate by RECIST 1.1. The secondary endpoints include overall survival, progression free survival, one year survival, objective response rate, PFS at six months, duration of response, and toxicity profile. Novocure is the study sponsor and Roche is providing atezolizumab for the trial.

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 are 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 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 20,000 patients have been treated with TTFields.

Source: Novocure.

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