Zai Lab, a China-focused biopharma company that focuses on treatments for cancer and autoimmune diseases, announced positive data for its clinical trial on Zejula (niraparib) for ovarian cancer.
Zai Lab, a China-focused biopharma company that focuses on treatments for cancer and autoimmune diseases, announced positive data for its clinical trial on Zejula (niraparib) for ovarian cancer. The news is promising, but the troubling recent history at Zai Lab may cast a shadow over the trial results.
Zejula was tested in the Phase III PRIME study, a trial testing Zejula, a poly (ADP-ribose) polymerase (PARP) inhibitor. Designed to treat patients with ovarian cancer who had already been treated with platinum-based chemotherapy, the drug is intended as a monotherapy to maintain treatment. The trial included 384 patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer—all of which can be categorized as types of ovarian cancer. The study’s endpoint was progression-free survival (PFS).
The trial’s results were encouraging. The PRIME study showed patients treated with Zejula had a significantly longer PFS of 24.8 months, compared to a placebo PFS of 8.3 months.
“The PRIME study is the only study conducted in China that has demonstrated that a PARP inhibitor significantly improved PFS when given as first-line monotherapy maintenance treatment in all Chinese patients with newly diagnosed advanced ovarian cancer, regardless of biomarker status and postoperative residual disease status,” said Dr. Lingying Wu, director of the department of gynecologic oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College.
It’s great news for patients, and it’s also good news for Zai Lab’s bottom line. The demand for immuno-oncology drugs such as PARPs is expected to top $34 billion by 2030. According to the press release, more than 37,000 patients die from ovarian cancer each year in China, and another 55,000 will be diagnosed annually.
This positive follows some negative press for the company. Zai Lab, along with Chinese biopharma giant BeiGene, was included in five Chinese companies that Wall Street threatened to delist if the companies did not comply with audit orders from the U.S. Securities and Exchange Commission. Because of regulations by the Chinese government, these companies were not providing adequate annual reports to the SEC.
The warning from the SEC may have contributed to shares of Zai Lab being at $29.62 as of last week, compared to $142 per share in March 2021.
Additionally, the U.S. Food and Drug Administration announced in February that it would be slowing down the process of approving medications from China. The FDA had concerns that the data provided by the Chinese companies did not hold up to U.S. regulatory approval standards.
Zai Lab has also made recent headlines due to its leadership. Last year, Josh Smiley, who was the chief financial officer at Eli Lilly, left the company due to “poor judgment” and “inappropriate personal communications” with multiple employees. Last week, Smiley was appointed chief operating officer starting Aug. 1 at Zai Lab.
Even so, Zai Lab isn’t deterring its plans for growth. The company maintains its strong collaboration and license agreement with GlaxoSmithKline to develop and commercialize Zejula in mainland China, Hong Kong and Macau.
Besides Zejula, Zai is also heavily investing in a drug called KarXT (xanomeline-trospium) developed by Karuna Pharmaceuticals. Zai Lab and Karuna announced in November 2021 that they were entering into an exclusive licensing agreement for the investigational psychiatric drug for use in China, Hong Kong, Taiwan and Macau. Zai Lab is currently funding all development, regulatory and commercialization activities for the drug in China.
