Zai Lab Announces First Patient Treated in Greater China in Pivotal Phase 3 PANOVA-3 Trial of Pancreatic Cancer Tumor Treatment Fields
SHANGHAI, SAN FRANCISCO and CAMBRIDGE, Mass., January 12, 2022 (GLOBE NEWSWIRE) – Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative, patient-centric, commercial-stage global biopharmaceutical company announced today This is the treatment of the first patient in Greater China in the PANOVA-3 trial, a pivotal phase 3 trial of tumor treatment fields in patients with pancreatic cancer.
“Pancreatic cancer is a common and very aggressive form of gastrointestinal cancer, with an estimated five-year survival rate of only around 7% in China,” said Alan Sandler, MD, president, head of global development, oncology, at Zai Lab. “As the majority of cases have progressed to an advanced stage, there remains an urgent clinical need for more effective treatment options. Tumor Treating Fields has already been approved in the United States for glioblastoma and mesothelioma and in China for glioblastoma, and we believe it also represents a promising therapeutic approach for patients with pancreatic cancer.
PANOVA-3 is a global, open-label, randomized phase 3 trial evaluating the efficacy of tumor treatment fields co-administered with gemcitabine and nab-paclitaxel as first-line treatment for patients with cancer of the breast. locally advanced unresectable pancreas. The trial is expected to enroll approximately 556 patients. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, local progression-free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, resectability rate, and toxicity.
About pancreatic cancer in China
Pancreatic cancer is one of the most common and deadly cancers in the world. In China, there are an estimated 124,994 new cases per year, according to the World Cancer Report 2020, and it is now the eighth most common type of cancer. The current median survival of patients with metastatic pancreatic cancer is four to six months, and the five-year survival rate was 7.2%1, making it the malignant tumor with the lowest survival rate in China.
There is an urgent need to improve the clinical outcomes of treatment for pancreatic cancer. Pancreatic cancer is difficult to diagnose at an early stage because the disease does not cause easily detectable symptoms due to the location of the pancreas deep in the abdomen. Less than 20% of patients are eligible for surgical resection, which is the only potentially curative treatment. Even after radical surgery, many patients have disease recurrence. For patients with locally advanced unresectable or distantly metastasized pancreatic cancer, chemotherapy remains the main treatment and the post-treatment median survival is less than one year.
1Pancreatic cancer: a review of epidemiology, trends and risk factors. World J Gastroenterol. July 21, 2021; 27 (27): 4298-4321.
About the fields of tumor treatment
Tumor Treatment Fields, or TTFields, are electrical fields that disrupt the division of cancer cells. Basic scientific research on TTFields spans more than two decades, and in all preclinical research to date, TTFields has demonstrated a consistent antimitotic effect. TTFields are primarily intended for use with other standard cancer treatments. There is a growing body of evidence supporting the wide applicability of TTFields with certain other cancer therapies, including radiotherapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields has shown no systemic toxicity, with mild to moderate skin irritation being the most common side effect. TTFields’ global development program includes a network of preclinical collaborators and a wide range of clinical trials across all phases, including four pivotal Phase 3 trials in a variety of tumor types. To date, over 20,000 patients have been treated with TTFields.
About Zai Lab
Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, patient-focused, commercial-stage global biopharmaceutical company focused on the development and commercialization of therapies that address medical conditions with unmet need in oncology , autoimmune diseases, infectious diseases and neurosciences. To this end, our experienced team has partnered with leading global biopharmaceutical companies to generate a broad portfolio of commercialized products and innovative product candidates. We have also assembled an in-house team with strong product discovery and translational research capabilities and are in the process of establishing a pipeline of proprietary product candidates with global rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing and marketing our portfolio to impact human health around the world.
Zai Lab forward-looking statements
This press release contains statements about future expectations, plans and prospects, including, without limitation, statements relating to the prospects and plans for the development and commercialization of the tumor treatment fields in the region of Greater China. These forward-looking statements may contain words such as “aim”, “anticipate”, “believe”, “could”, “estimate”, “expect”, “foresee”, “objective”, “intend” , “Power”, “plan”, “possible”, “potential”, “will”, “would” and other similar expressions. These 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 our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances which may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements due to various important factors including, but not limited to (1) our ability to successfully market and generate income from our approved products, (2) our ability to fund our operations and business initiatives and obtain funding for these activities, (3) our clinical and preclinical development results of our product candidates, (4) the content and timing of decisions made by regulatory authorities competent regarding regulatory approvals of our product candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on our business and general economic, regulatory and political conditions, and (6) the risk factors identified in our most recent annual or quarterly report and in other reports we have filed with the Securities and Exchange Commission the United States. We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we assume no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless it is necessary. by the law. These forward-looking statements should not be taken as representing our views as of any date subsequent to the date of this press release.
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Source: Zai Lab Limited