Zai Lab to Present Analysis of the Impact of Timing for ZEJULA® (niraparib) Maintenance Treatment in Newly Diagnosed Advanced Ovarian Cancer at the 2022 International Gynecologic Cancer Society 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
“This PRIME study analysis will help support clinical practice in treating advanced ovarian cancer in
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
About PRIME Study
The fully powered Phase 3 PRIME study was evaluated in 384 advanced ovarian cancer patients who were in a complete or partial response to platinum-based chemotherapy and who were randomized 2:1 to receive ZEJULA or placebo as maintenance therapy. The study evaluated the efficacy of ZEJULA as a maintenance treatment, with the primary endpoint of PFS as assessed by blinded independent central review. The starting dose was individualized at 200 mg except for those patients with a baseline body weight ≥ 77kg and a platelet count ≥ 150K/μL, in which case the starting dose was 300 mg.
About Ovarian Cancer
Ovarian cancer is one of the most common gynecologic cancers in China, with over 55,000 newly diagnosed cases and 37,000 deaths in China annually1. While platinum-based chemotherapy is effective at inducing an initial response in ovarian cancer, the disease will recur in the majority of women. New agents that prolong the duration of response following platinum-based treatment and delay the relapse of ovarian cancer will benefit patients with ovarian cancer in China.
1 Globocan 2020.
About ZEJULA (niraparib)
ZEJULA (niraparib) is an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor indicated as monotherapy for the maintenance treatment of adult patients with newly diagnosis and platinum-sensitive relapsed advanced and recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
In addition to the PRIME study, Zai Lab has completed several studies in Chinese patients with ovarian cancer:
- In September 2020, Zai Lab announced that ZEJULA demonstrated a significant PFS benefit with an improved safety profile in the company’s Phase 3 NORA study of ZEJULA as maintenance therapy for Chinese patients with platinum-sensitive, recurrent ovarian cancer, regardless of biomarker status.
- A Phase 1 pharmacokinetic study of ZEJULA was conducted in Chinese patients with ovarian cancer.
Zai Lab has a collaboration and license agreement with GSK for the development and commercialization of ZEJULA (independently manufactured by
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Zai Lab Forward-Looking Statements
This press release contains forward-looking statements relating to our Phase 3 PRIME study of ZEJULA® (niraparib); clinical development programs; clinical trial data, data readouts, and presentations; risks and uncertainties associated with drug development and commercialization; and the potential benefits, safety, and efficacy of our collaboration partners’ products and of our pipeline therapies. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic, including any government actions or lockdown measures taken in response, on our business and general economic, regulatory, and political conditions, (6) risks related to doing business in
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Source: Zai Lab Limited