• PRIME study demonstrates that niraparib treatment had a clinically meaningful and statistically significant benefit in improving progression-free survival in the overall study population regardless of biomarker status when compared to placebo
• Treatment was tolerable in the population studied and showed a safety profile consistent with previous trials
• Zai Lab plans to present the PRIME study data at an upcoming medical conference
SHANGHAI, SAN FRANCISCO, and CAMBRIDGE, Mass., Nov. 30, 2021 (GLOBE NEWSWIRE) — Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))))), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, today announced that the Phase 3 PRIME study of ZEJULA (niraparib) as maintenance therapy met its primary endpoint. ZEJULA demonstrated a statistically significant and clinically meaningful progression-free survival (PFS) benefit with a tolerable safety profile in Chinese patients with newly diagnosed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (collectively termed as ovarian cancer) following a response to platinum-based chemotherapy, regardless of biomarker status.
“I believe the data of the PRIME study will have a significant impact on the clinical practice in the first-line treatment of ovarian cancer in China and beyond, as the individualized starting dose regimen has demonstrated an improved safety profile,” 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. “In addition, the PRIME study is the only study conducted in China that has demonstrated that a PARP inhibitor significantly improved PFS when given as monotherapy maintenance therapy in all Chinese patients with newly diagnosed ovarian cancer, regardless of biomarker status.”
“The PRIME clinical data in Chinese patients confirmed the clinical profile of ZEJULA and were consistent with the results seen in the global PRIMA study,” said Alan Sandler, M.D., President and Head of Global Development, Oncology, Zai Lab. “Importantly, the PRIME study further underscores the status of ZEJULA as the first and only PARP inhibitor approved globally, including in China, as monotherapy for all-comer patients in the first-line maintenance treatment settings.”
In September 2020, the China National Medical Products Administration (NMPA) approved ZEJULA’s supplemental New Drug Application (sNDA) as a maintenance treatment of adult patients with advanced ovarian cancer who are in a complete or partial response to first-line platinum-based chemotherapy. ZEJULA was also approved by the Hong Kong Department of Health as a maintenance treatment for adult patients with high-grade serous epithelial ovarian cancer who are in a complete response or partial response to first-line platinum-based chemotherapy.
ZEJULA is seeking National Reimbursement Drug List (NRDL) inclusion for a first-line ovarian cancer indication.
