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NOVA / ENGOT­-OV16

Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer

Date of Publication:

October 8, 2016

Pubmed Link:
https://pubmed.ncbi.nlm.nih.gov/27717299/
Hypothesis:

Does addition of niraparib maintenance improve PFS in women with recurrent, platinum-sensitive ovarian cancer?

Control Arm(s):

Placebo

Experimental Arm(s):

Niraparib 300mg PO daily

continued until progression

Primary End Point:

PFS

Inclusion Criteria:

Recurrent ovarian cancer

predominantly high-grade serous histology

Complete or partial response to at least 4 cycles of platinum-based chemotherapy

Exclusion Criteria:

>2 cm measurable disease at the end of treatment for recurrence

Elevated CA125 following treatment or less than 90% CA125 decline from treatment

Results:

Niraparib vs. placebo:

median PFS, BRCAm: 21.0 vs. 5.5 mos (SS)

median PFS, HRD: 12.9 vs. 3.8 mos (SS)

median PFS, HR proficient: 6.9 vs. 3.8 mos; (SS)

median PFS, BRCAwt: 9.3 vs. 3.9 mos (SS)

Grade 3+ adverse events 74.1% vs. 22.9% (hematolotic)

Conclusions:

Maintenance niraparib improves PFS after platinum-sensitive of ovarian cancer recurrence, regardless of BRCA or HRD status.

Reviewer:
Ross Harrison, OTF