Zai Lab Announces First Patient Treated in Greater China in PANOVA-3 Phase 3 Pivotal Trial of Tumor Treating Fields in Pancreatic Cancer

Rhea-AI Summary

Zai Lab Limited (NASDAQ: ZLAB) announced the treatment of the first patient in Greater China in the PANOVA-3 trial. This pivotal Phase 3 trial investigates Tumor Treating Fields for pancreatic cancer, a highly aggressive cancer with a low five-year survival rate of about 7% in China. The trial will enroll approximately 556 patients, focusing on overall survival and various secondary endpoints. Given the urgent need for effective treatments, the promising results of Tumor Treating Fields previously approved for other cancers highlight the potential impact on patient outcomes.

Positive

• Initiation of PANOVA-3 trial for Tumor Treating Fields in pancreatic cancer.
• Potential to improve treatment outcomes for patients with advanced pancreatic cancer.

Negative

• Pancreatic cancer has a low five-year survival rate of around 7% in China.
• Current treatment options show median survival of less than one year for unresectable cases.

SHANGHAI, SAN FRANCISCO, and CAMBRIDGE, Mass., Jan. 12, 2022 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced treatment of the first patient in Greater China in the PANOVA-3 trial, a Phase 3 pivotal trial of Tumor Treating Fields in patients with pancreatic cancer.

“Pancreatic cancer is a common, highly aggressive form of gastrointestinal cancer, with an estimated five-year survival rate of only about 7% in China,” said Alan Sandler, M.D., 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 U.S. for glioblastoma and mesothelioma and in China for glioblastoma, and we believe that it represents a promising therapeutic approach for patients with pancreatic cancer as well.”

PANOVA-3 is a global, open-label, randomized Phase 3 trial evaluating the efficacy of Tumor Treating Fields administered concomitantly with gemcitabine and nab-paclitaxel as front-line treatment for patients with unresectable, locally advanced pancreatic cancer. 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 deadliest cancers globally. In China, there are an estimated 124,994 new cases per year, according to World Cancer Report 2020, and it is now the eighth most common cancer type. 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 malignancy with the lowest survival rate in China.

There is an urgent need to improve the clinical outcomes of pancreatic cancer treatment. Pancreatic cancer is difficult to diagnose in early stages, as the disease does not cause easily detectable symptoms because of the location of the pancreas deep within the abdomen. Fewer than 20% of patients are eligible for surgical resection, which is the only potentially curative therapy. Even after radical surgery, many patients have disease recurrence. For patients with unresectable locally advanced or remotely metastasized pancreatic cancer, chemotherapy is still the primary treatment, and median post-treatment survival is less than one year.

¹Pancreatic cancer: A review of epidemiology, trend, and risk factors. World J Gastroenterol. 2021 Jul 21; 27(27): 4298–4321.

About Tumor Treating Fields

Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division. Fundamental scientific research on TTFields extends across more than two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. 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. 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.

About Zai Lab

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is a patient-focused, innovative, commercial-stage, global biopharmaceutical company focused on developing and commercializing therapies that address medical conditions with unmet needs in oncology, autoimmune disorders, infectious diseases, and neuroscience. To that end, our experienced team has secured partnerships with leading global biopharmaceutical companies in order to generate a broad pipeline of innovative marketed products and product candidates. We have also built an in-house team with strong product discovery and translational research capabilities and are establishing a pipeline of proprietary product candidates with global rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing, and commercializing our portfolio in order to impact human health worldwide.

For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.

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 developing and commercializing Tumor Treating Fields in the Greater China region. These forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” 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 our 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) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to finance our operations and business initiatives and obtain funding for such activities, (3) our results of clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities 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 U.S. Securities and Exchange Commission. We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to 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 our views as of any date subsequent to the date of this press release.

For more investor-related information about Zai Lab, please go to www.SEC.gov or visit www.zailaboratory.com.

For more information, please contact:

Investor Relations: Ron Aldridge / Lina Zhang
+1 (781) 434-8465 / +86 136 8257 6943
ronald.aldridge@zailaboratory.com / lina.zhang@zailaboratory.com

Media: Danielle Halstrom / Xiaoyu Chen
+1 (215) 280-3898 / +86 185 0015 5011
danielle.halstrom@zailaboratory.com / xiaoyu.chen@zailaboratory.com

Source: Zai Lab Limited

FAQ

What is the PANOVA-3 trial for Zai Lab (ZLAB)?

The PANOVA-3 trial is a Phase 3 pivotal study investigating the efficacy of Tumor Treating Fields combined with gemcitabine and nab-paclitaxel for treating unresectable, locally advanced pancreatic cancer.

What are the objectives of the PANOVA-3 trial conducted by Zai Lab?

The main objective is to evaluate overall survival, while secondary objectives include progression-free survival, local progression-free survival, and quality of life metrics.

What is the significance of Tumor Treating Fields in pancreatic cancer treatment?

Tumor Treating Fields have shown promise as a novel treatment option for pancreatic cancer, potentially improving survival rates, especially for patients who are not candidates for surgery.

When was the first patient treated in the PANOVA-3 trial by Zai Lab?

The first patient was treated on January 12, 2022, marking a significant step in the trial aimed at addressing a critical need in pancreatic cancer treatment.