Takeda Korea said on Monday that its PARP inhibitor, Zejula (niraparib), has confirmed long-term, continuous progression-free survival (PFS) and disease resolution in the primary maintenance treatment of newly diagnosed patients with progressive ovarian cancer.
The median follow-up period was 3.5 years and 79 patients (16.3%) in the Zejula group and 27 (11.1%) in the placebo group were continuing treatment at the clinical cut-off date.
Consistent long-term progression-free survival benefits were observed in the overall patient population and in the patient group receiving Zejula across all biomarker subgroups. The median value for progression-free survival in the group receiving ZeJula was 13.8 months, compared with 8.2 months in the placebo group.
In a biomarker-based sub-analysis, Zejula demonstrated clinically meaningful benefits in terms of improved progression-free survival compared to placebo, and reduced disease progression or risk of death in the treatment group. patients with homologous recombination deficiency (HRD).
Meanwhile, in the HRD-positive patient group, the median survival period was improved to 24.5 months and the placebo group was only 11.2 months, showing a 48% reduction in median progression of the disease.
In particular, Zejula exhibited the best therapeutic effect in patients with breast cancer mutations (BRCA), even within the HRD-positive patient group.
In addition, serious adverse reactions that could lead to dose reduction and discontinuation decreased after application of the individualized starting dose (ISD) of Zejula. ISD is a method of administering 200 mg once daily to patients with a body weight below 77 kg or a platelet count below 150,000/μL.
“The long-term follow-up results of this PRIMA study are important for patients with progressive ovarian cancer, particularly BRCA-positive ovarian cancer, who need primary maintenance, to benefit the long-term effectiveness of Zejula.” said Takeda general manager of oncology, Lee Sun-jin.
Professor Kim Jae-won of Obstetrics and Gynecology at Seoul National University Hospital added, “Compared to the Zejula and placebo groups, there was a consistent difference of 21-23% in the PFS rate of 1 at 4 years post-treatment, and the HRD-negative HRP patients also showed a significant clinical effect.”