SHANGHAI and SAN FRANCISCO and CAMBRIDGE, Mass., Sept. 20, 2022 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))))), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, will present a poster featuring initiation timing analysis from the Phase 3 PRIME study of ZEJULA (niraparib) as maintenance therapy at the upcoming 2022 International Gynecologic Cancer Society (ICGS) Annual Meeting.
This post-hoc analysis of the PRIME Phase 3 study evaluated adults with newly diagnosed advanced ovarian cancer who responded to first-line platinum-based chemotherapy, and they were randomized to receive niraparib maintenance treatment or placebo within 12 weeks after chemotherapy completion. The results are as follows:
- For patients who received niraparib treatment less than 9 weeks after chemotherapy completion, the median progression-free survival (PFS) (95% CI) was measured at 29.4 months with niraparib versus 8.3 months with placebo (HR =0.31; 95% CI, 0.20–0.48).
- For patients who received niraparib at 9 – 12 weeks after chemotherapy completion, the median PFS was 24.7 months with niraparib versus 10.8 months with placebo (HR=0.60; 95% CI, 0.41–0.89).
- The initiation timing of niraparib maintenance treatment had no significant impact on its safety profile.
This subgroup analysis provides evidence to support the initiation of niraparib maintenance treatment in patients with newly diagnosed advanced ovarian cancer within 12 weeks after chemotherapy completion.
"We are excited to be presenting at the 2022 International Gynecologic Cancer Society Annual Meeting showing these results improved clinical efficacy when niraparib maintenance treatment is initiated within 12 weeks after chemotherapy in patients with advanced ovarian cancer," said Alan Sandler, M.D., President and Head of Global Development, Oncology, Zai Lab. "This study further supports ZEJULA as an important maintenance treatment therapy after platinum-based chemotherapy in people with advanced ovarian cancer."
"This PRIME study analysis will help support clinical practice in treating advanced ovarian cancer in China, showing niraparib extended progression-free survival when maintenance treatment begins within 12 weeks after chemotherapy," said Jing Wang, M.D., Director of the Early Clinical Research Center, Hunan Cancer Hospital. "Since a majority of women face recurrence of advanced ovarian cancer after chemotherapy, this study supports niraparib maintenance treatment having a significant clinical benefit in extending progression-free survival compared to placebo."
Details regarding the e-poster presentation at IGCS 2022 are as follows:
| Abstract number: 876 Title: Impact of initiation timing of niraparib maintenance treatment in newly diagnosed advanced ovarian cancer Speaker: Jing Wang, M.D., Hunan Cancer Hospital Date: September 29-October 1, 2022 |