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Niraparib

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Increased niraparib-induced cytotoxicity was observed in tumor cell lines with or without deficiencies in BRCA1/2. Niraparib decreased tumor growth in mouse xenograft models of human cancer cell lines with deficiencies in BRCA1/2 and in human patient derived xenograft tumor models with homologous recombination deficiency (HRD) that had either mutated or wild-type BRCA1/2.

 

14 CLINICAL STUDIES

14.1 First-Line Maintenance Treatment of Advanced Ovarian Cancer

HRD positive status included either tumor BRCA mutant (tBRCAm) or a genomic instability score (GIS) ≥42.

 

14.2 Maintenance Treatment of Recurrent Ovarian Cancer

Patients with deleterious or suspected deleterious germline BRCA mutations (gBRCAm) were assigned to the germline BRCA mutated (gBRCAmut) cohort (n = 203), and those without germline BRCA mutations were assigned to the non-gBRCAmut cohort (n = 350).

 

The trial demonstrated a statistically significant improvement in PFS for patients randomized to ZEJULA as compared with placebo in the gBRCAmut cohort and the non-gBRCAmut cohort.

 

 

(2023.10.06 업데이트)

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