Zai Lab Announces First Patient Treated in Greater China in METIS Phase 3 Pivotal Trial of Tumor Treating Fields in Brain Metastases from Non-Small Cell Lung Cancer
“I am excited that
The METIS trial (also known as the EF-25 trial) is a pivotal, randomized, controlled Phase 3 trial designed to test the efficacy and safety of TTFields, generated by a medical device, the NovoTTF-100M System, in patients with 1-10 newly diagnosed brain metastasis from NSCLC. TTFields are administered to patients concomitantly with the best standard of care treatments that would normally be used to treat lung cancer. The trial is expected to enroll 270 patients randomized 1:1 to receive, following radiosurgery, either TTFields at a frequency of 150kHz plus supportive care or supportive care alone. The primary endpoint is time to first cerebral progression. Secondary endpoints include, among others, time to neurocognitive failure, overall survival, and radiological response rate.
About Brain Metastasis from NSCLC in
Lung cancer consists of NSCLC in approximately 85% of cases and small cell lung cancer (SCLC) in approximately 15% of cases. Lung cancer has the highest total incidence of any cancer in China. According to the World Health Organization, the incidence of lung cancer in China in 2020 was 815,563 cases, with 714,699 deaths. About 7%–10% of NSCLC patients evidence brain metastases at the time of initial diagnosis, and approximately 20%–40% of patients develop brain metastases at some point during their illness.i ii The average survival for these patients is about six months from diagnosis.i
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 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 has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect.
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i Ali, A., Goffin, J. R.,
ii Liu, Q., Tong, X. & Wang, J. Management of brain metastases: history and the present. Chin Neurosurg Jl 5, 1 (2019). https://doi.org/10.1186/s41016-018-0149-0
Source: Zai Lab Limited