Zai Lab Limited (NASDAQ:ZLAB) presented data from the Phase 3 PRIME study of Zejula (niraparib) as maintenance therapy in Chinese ovarian cancer patients.
- Zejula demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) with a tolerable safety profile with newly diagnosed ovarian cancer following response to platinum-based chemotherapy, regardless of biomarker status.
- The median Progression-free survival (PFS) was significantly longer for patients treated with niraparib than placebo: 24.8 months versus 8.3 months.
- Overall survival data are still immature (percentage of death in niraparib and placebo groups are 14.5% vs. 21.7%); there is a trend in favor of niraparib at the data cut-off.
- The safety profile of niraparib was improved with the individualized starting dosing (ISD) prospectively applied to all patients.
- In December 2021, the National Reimbursement Drug List (NRDL) released by China's National Healthcare Security Administration (NHSA) was updated to include Zejula as a first-line maintenance treatment of ovarian cancer.
- Price Action: ZLAB shares traded lower by 1.63% at $38.10 on the last check Monday.
