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PRIMA

Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer

Date of Publication:

December 19, 2019

Pubmed Link:
https://www.ncbi.nlm.nih.gov/pubmed/31562799
Hypothesis:

Does the addition of Niraparib maintenance improve PFS in women with advanced ovarian cancer?

Control Arm(s):

Placebo PO daily

q28 day cycles x36 months or until disease progression

Experimental Arm(s):

Niraparib 300mg/200mg PO daily

Primary End Point:

PFS

Inclusion Criteria:

Stage III/IV endometrioid or high grade serous ovarian cancer

prior platinum based chemotherapy with CR or PR

Exclusion Criteria:
Results:

Niraparib vs Placebo:

median PFS, HRD: 21.9 vs 10.4 months (SS)

median PFS, HRD/BRCAm: 22.1 vs 10.9 months (SS)

median PFS for HRD/BRCAwt: 19.6 vs 8.2 months (SS)

median PFS for HR proficient: 8.1 vs 5.4 months (SS)

median PFS: 13.8 vs 8.2 months (SS)

2yr OS: 84% vs 77% (not mature)

2yr OS, HRD: 91% vs 85% (not mature)

Grade >3 adverse events: 70.5% vs 18.9% (most common: anemia, thrombocytopenia, neutropenia)

Conclusions:

Treatment with niraparib maintenance imrpoved PFS in all considered populations, including the whole cohort.

Reviewer:
Courtney Griffiths, OTF