SHANGHAI & ST. HELIER, Jersey--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB), a China and U.S.-based innovative commercial stage biopharmaceutical company, and Novocure (NASDAQ: NVCR), a global oncology company with a proprietary platform technology called Tumor Treating Fields, today announced that 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 U.S.,” 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.
About Gastric Cancer
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.
About Tumor Treating Fields
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 U.S. 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.
About Zai Lab
Zai Lab (NASDAQ: ZLAB) is a China and U.S.-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 U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania and New York City. Additionally, the company has offices in Germany, Switzerland, Japan and Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.
Zai Lab Forward-Looking Statements
This press release contains statements about future expectations, plans and prospects for Zai Lab, including plans for commercializing Tumor Treating Fields in China and the potential for Tumor Treating Fields to treat a wide variety of solid tumors. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and are identified by words such as "anticipates", “believes”, "expects", “plan” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact nor are they guarantees or assurances of future performance. Forward-looking statements are based on Zai Lab’s expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) Zai Lab’s ability to obtain additional future funding, (2) Zai Lab’s results of clinical and pre-clinical development of its drug candidates, (3) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of Zai Lab’s drug candidates, (4) Zai Lab’s ability to generate revenue from its drug candidates, and (5) other factors discussed in Zai Lab's Annual Report on Form 20-F for the fiscal year ended December 31, 2018 and its other filings with the Securities and Exchange Commission. Zai Lab anticipates that subsequent events and developments will cause Zai Lab’s expectations and assumptions to change and undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing Zai Lab’s views as of any date subsequent to the date of this press release.
Novocure Forward-Looking Statements
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical trial progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Quarterly Report on Form 10-Q filed on July 25, 2019, with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.