Zai Lab Presents Interim Overall Survival Data for ZEJULA® (niraparib) from the NORA Phase 3 Study at the ESMO Virtual Plenary
- Median overall survival (mOS) was numerically longer for patients receiving ZEJULA regardless of biomarker status, at 46.3 months compared to 43.4 months in the placebo group
- No new safety issues were identified
The results showed that ZEJULA maintenance treatment using an individualized starting dose (ISD) regimen1 provides a favorable OS trend irrespective of gBRCA mutation status compared with placebo, despite that 43% (38/88) of patients in placebo arm received subsequently at least one dose of a PARP inhibitor post progression.
- mOS in the ITT population: 46.3 months for patients receiving ZEJULA versus 43.4 months for placebo group [HR=0.82; 95% CI, 0.56-1.21].
- mOS in gBRCA mutation subgroup: Not reached for patients receiving ZEJULA versus 47.6 months for placebo group [HR=0.76; 95% CI, 0.40-1.46].
- mOS in non-gBRCA mutation subgroup: 43.1 months for patients receiving ZEJULA versus 38.4 months for placebo group [HR=0.86; 95% CI, 0.53-1.38].
- No new safety signals were identified based on long-term follow-up. Median follow-up time for OS in ZEJULA and placebo arm was 45.7 and 44.5 months, respectively.
Based on the OS analysis adjusted for subsequent PARP inhibitor therapy2,
- mOS in the ITT population: 46.3 months for patients receiving ZEJULA versus 34.3 months for placebo group [HR=0.69; 95% CI, 0.45-1.07].
- mOS in gBRCA mutation subgroup: Not reached for patients receiving ZEJULA versus 42.1 months [HR=0.88; 95% CI 0.39-2.01].
- mOS in non-gBRCA mutation subgroup: 43.1 months for patients receiving ZEJULA versus 32.6 months [HR=0.62; 95% CI 0.37-1.05].
The final prespecified OS analysis of the NORA study is expected in 2023.
“We are proud to present this new interim OS data analysis from the NORA study for Chinese patients at ESMO, as it adds to the already existing body of evidence from the study to support the clinical profile of ZEJULA as a second-line maintenance therapy for ovarian cancer regardless of biomarker status,” said
The NORA study was evaluated in 265 platinum-sensitive recurrent ovarian cancer patients randomized 2:1 to receive niraparib or placebo until disease progression. 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 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 annually3. 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 NORA was initially designed to evaluate the efficacy and safety profile of niraparib in Chinese patients with PSROC using a fixed starting dose (FSD) of 300mg orally daily. After the first 16 patients were treated with FSD, the NORA protocol was amended to use an ISD based on the NOVA retrospective analysis that the ISD may improve the safety profile of niraparib without compromising efficacy.
2 In the adjusted OS analysis, patients in the placebo group who switched to PARP inhibitor were censored at time of switch-over.
3 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 advanced and recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to first- and second-line platinum-based chemotherapy.
Zai Lab has completed several other studies in patients with ovarian cancer in
March 2022, Zai Labannounced that, in the company’s Phase 3 PRIME study, ZEJULA demonstrated a statistically significant and clinically meaningful improvement in PFS with a tolerable safety profile when given with an individualized starting dose regimen in Chinese patients with newly diagnosed advanced 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 future expectations, plans, and prospects, including, without limitation, statements relating to the benefits, safety, and efficacy of ZEJULA (niraparib); the treatment of ovarian cancer in mainland
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Source: Zai Lab Limited