Positive Phase 3 clinical data of Zai Lab's niraparib in first-line maintenance treatment of ovarian cancer patients in China

Transfer from | Medicine Guanlan

On March 21, Zai Lab announced that it had reported detailed data from the PRIME Phase 3 clinical study of niraparib as maintenance therapy at the American Society of Gynecologic Oncology (SGO) annual meeting

Niraparib is a once-daily oral PARP inhibitor indicated as a single agent for adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have achieved a complete or partial response to first-line platinum-based chemotherapy.

The PRIME study announced today is a randomized, controlled, double-blind Phase 3 clinical trial evaluating niraparib in 384 patients with advanced ovarian cancer who achieved a complete response or After partial remission, patients were randomly assigned to niraparib or placebo to receive maintenance therapy

Data from this phase 3 clinical trial showed that maintenance therapy with niraparib had a statistically and clinically significant benefit in improving PFS in the entire population compared with placebo, regardless of biomarker status; the PRIME study achieved The primary study endpoint, the median PFS of patients in the niraparib group was 24.

Other prespecified efficacy outcomes of the study included: Among patients with gBRCA mutations, median PFS in the niraparib group was not yet reached, compared with 10.

In addition, in the PRIME study, the safety profile of niraparib maintenance therapy improved with individualized starting doses prospectively applied to all patients

References:

[1] Research data released! Positive results of PRIME Phase 3 clinical study of niraparib in first-line maintenance therapy for ovarian cancer in China.

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Original title: Zai Lab Announces Phase 3 Clinical Data of Niraparib for First-Line Maintenance Treatment of Ovarian Cancer in China!