On October 4, 2021 Novocure (NASDAQ: NVCR), a global oncology company working to extend survival in some of the most aggressive forms of cancer, and Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, reported that the final patient has been enrolled in a Novocure-sponsored phase 2 pilot trial conducted by Zai Lab evaluating the safety and efficacy of Tumor Treating Fields (TTFields) in combination with chemotherapy as a first-line treatment in patients with gastric adenocarcinoma (Press release, NovoCure, OCT 4, 2021, View Source [SID1234590758]). Final data collection is expected in the first half of 2022.
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"The execution of this phase 2 pilot trial in gastric cancer reflects our commitment to bringing Tumor Treating Fields to as many patients as possible in Greater China," said Alan Sandler, M.D., President and Head of Global Development, Oncology at Zai Lab. "Gastric cancer is the third most common cancer in China in incidence and mortality and a significant unmet medical need. Late diagnosis contributes to poor prognosis in advanced gastric cancer patients. This trial, conducted entirely in China, showcases Zai’s capabilities as we partner with Novocure to expand treatment options for gastric cancer patients in China."
The phase 2 pilot gastric cancer trial of TTFields has enrolled approximately 30 patients in Greater China. The single arm, open-label, multi-center study is investigating the safety and efficacy of TTFields in combination with chemotherapy as the first-line treatment of unresectable gastric adenocarcinoma, or gastroesophageal junction adenocarcinoma. In the study, patients receive TTFields and XELOX (capecitabine / oxaliplatin) chemotherapy until disease progression. The primary endpoint is investigator-assessed objective response rate. The protocol is designed to include 25 evaluable patients who receive at least one tumor assessment.
"We believe that Tumor Treating Fields’ mechanism of action is broadly applicable to treat solid tumor cancers," said Asaf Danziger, Novocure’s Chief Executive Officer. "We look forward to seeing results from this phase 2 pilot trial with our partner, Zai Lab, and to further exploring the potential of Tumor Treating Fields as a treatment for gastric cancer."
About Gastric Cancer
Gastric cancer is the third largest cancer in China. According to Globocan 2020 estimates, more than one million new gastric cancer cases are diagnosed worldwide annually, and approximately half of all gastric cancer cases occur in China. Currently, the five-year survival rate of locally advanced or metastatic gastric cancer ranges from 5 percent to 20 percent, and the median overall survival is approximately one year.
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.