Zai Lab Doses First Patient in Phase III Trial of ZL-2306 (niraparib) in Patients with Small-Cell Lung Cancer in China
First study of niraparib for this indication worldwide; a significant medical need in China
SHANGHAI, China, Aug. 28, 2018 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB), a Shanghai-based innovative biopharmaceutical company, today announced dosing of the first patient in a Phase III trial of ZL-2306 (niraparib) in patients with small-cell lung cancer (SCLC).
The Phase III trial is a double-blind, placebo-controlled study randomizing 591 patients 2:1 for ZL-2306 (niraparib) vs. placebo as maintenance therapy with extensive-stage disease SCLC (ED-SCLC) who have responded to multiple cycles of first-line platinum-based chemotherapy. The primary endpoints are progression-free survival (PFS), adjudicated by blinded independent central review, and overall survival (OS). Secondary endpoints include investigator-assessed PFS, change in patient outcomes and safety. More information can be found at https://clinicaltrials.gov/ct2/show/NCT03516084?term=niraparib&draw=2&rank=42
“Maintenance therapy for SCLC patients who have responded to first-line therapy is urgently needed to extend survival but no such treatment has yet been approved anywhere in the world,” said Dr. Samantha Du, Chief Executive Officer of Zai Lab. “The large patient population with SCLC in China represents a high unmet need and we believe that ZL-2306 has the potential to be developed as an important therapeutic option for these patients. This study is an important part of our comprehensive clinical development program for ZL-2306 with the goal to establish ZL-2306 as the leading PARP inhibitor in China.”
Lung cancer is the most common cancer in China with annual incidence rate of over 730,000 patients as of 2015. Lung cancer is also the leading cause of cancer death in China with annual mortality rate of over 610,000 as of 2015. SCLC makes up approximately 15-20% of China’s lung cancer patients and SCLC is an area with high unmet clinical need. The standard of care is platinum-based chemotherapy; however, responders to this therapy typically relapse and there are no adequate alternative regimens to treat these patients.
About ZL-2306ZL-2306 (niraparib) is a highly potent and selective oral, once-daily small molecule poly (ADP-ribose) PARP 1/2 inhibitor. Niraparib was approved in March 2017 by the FDA in the U.S. and by the EMA in the EU under the trade name ZEJULA® in November 2017 as a maintenance treatment for women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Based on the approval status in the U.S. and EU, Zai Lab submitted a market registration application for niraparib in Hong Kong and plans to launch and commercialize niraparib in Hong Kong in the second half of 2018. Zai Lab believes ZL-2306 (niraparib) has the potential to be a first-in-class Category 1 drug for treatment across multiple solid tumor types in China.
About Zai LabZai Lab (NASDAQ:ZLAB) is a Shanghai-based innovative biopharmaceutical company focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world. The company’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 global 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.
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