Zai Lab & Novocure Announce First Patient Enrolled in a Phase 2 Pilot Trial
Zai Lab Limited and Novocure recently announced the first patient has been enrolled in a Phase 2 pilot clinical trial evaluating the safety and efficacy of Tumor Treating Fields in combination with chemotherapy as a first-line treatment in patients with gastric adenocarcinoma.
“Zai Lab licensed Tumor Treating Fields from Novocure in September 2018, and we have since launched Optune in Hong Kong for the treatment of patients with recurrent, or newly diagnosed glioblastoma multiforme (GBM) and submitted a Marketing Authorization Application to the China National Medical Products Administration (NMPA) for approval,” said Dr. Samantha Du, Founder and CEO of Zai Lab. “Optune also has been granted the Innovative Device Designation, which allows our team to accelerate dialogue with the NMPA. What is especially attractive about Tumor Treating Fields is its potential applicability to treat a wide variety of solid tumors, including gastric cancer, the second most common cancer in China in terms of incidence rate. The initiation of this Phase 2 pilot trial in gastric cancer represents our commitment to bringing Tumor Treating Fields to as many patients who may benefit in Greater China.”
“Tumor Treating Fields is already approved for glioblastoma and malignant pleural mesothelioma in the US,” added William Doyle, Executive Chairman of Novocure. “We are moving forward with multiple clinical trials to evaluate Tumor Treating Fields for other indications including brain metastases, non-small cell lung cancer, pancreatic cancer, and ovarian cancer. It is very gratifying to see our partner engaged in active dialogue with the NMPA and studying Tumor Treating Fields for gastric cancer, a serious and unmet medical need in China.”
The Phase 2 pilot gastric cancer trial of Tumor Treating Fields is expected to enroll approximately 50 patients in Greater China. The study is a single arm, open-label, multi-center study, investigating the safety and efficacy of Tumor Treating Fields in combination with chemotherapy as the first-line treatment of unresectable gastric adenocarcinoma, or gastroesophageal junction adenocarcinoma. In the study, patients will receive Tumor Treating Fields at 150 kHz and XELOX chemotherapy, a combination of oxaliplatin and capecitabine, until disease progression. The primary endpoint is investigator-assessed objective response rate.
Gastric cancer is the second most common cancer in China (679,100 newly diagnosed cases in 2015) and the second leading cause of death in China (498,000 deaths in 2015). The 5-year overall survival rate of gastric cancer is only 35.9%. Current therapies include surgery, chemotherapy, radiotherapy and targeted therapy, which prolong progression free survival and overall survival to 6 months and 8-14 months, respectively.
Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth, and potentially causing cancer cells to die. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with glioblastoma and in the US for mesothelioma, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types, including some of the most aggressive forms of cancer.
Zai Lab is a China- and US-based innovative commercial-stage biopharmaceutical company focused on bringing transformative medicines for cancer, autoimmune, and infectious diseases to patients in China and around the world. Zai Lab’s experienced team has secured partnerships with leading global biopharma companies, generating a broad pipeline of innovative drug candidates targeting the fast-growing segments of China’s pharmaceutical market and addressing unmet medical needs. Zai Lab’s vision is to become a fully integrated biopharmaceutical company, discovering, developing, manufacturing and commercializing its partners’ and its own products in order to impact human health worldwide.
Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division. Novocure’s commercialized products are approved for the treatment of adult patients with glioblastoma and malignant pleural mesothelioma. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer, liver cancer and gastric cancer. Headquartered in Jersey, Novocure has US operations in Portsmouth, NH, Malvern, PA, and New York City. Additionally, the company has offices in Germany, Switzerland, Japan, and Israel. For more information, visit www.novocure.com.
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