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VELIA

Veliparib with First-Line Chemotherapy and as Maintenance Therapy in Ovarian Cancer

Date of Publication:

September 28, 2019

Pubmed Link:
https://www.ncbi.nlm.nih.gov/pubmed/31562800
Hypothesis:

Does concurrent therapy with veliparib, with or without veliparib maintenance, improve PFS in patients with advanced ovarian cancer.

Control Arm(s):

carboplatin AUC 6 q3wks

paclitaxel 175 mg/m2 q3 wks or 80 mg/m2 q1 wk

Placebo PO BID

x6 cycles

placebo PO BID x30 cycles maintenance

Experimental Arm(s):

(1) carboplatin AUC 6 q3wks

paclitaxel 175 mg/m2 q3 wks or 80 mg/m2 q1 wk

Veliparib 150 mg PO DIB

x6 cycles

placebo PO BID x30 cycles maintenance

(2) carboplatin AUC 6 q3wks

paclitaxel 175 mg/m2 q3 wks or 80 mg/m2 q1 wk

Veliparib 150 mg PO DIB

x6 cycles

Velaparib 300 mg / 400mg PO BID x30 cycles maintenance

Primary End Point:

PFS

Inclusion Criteria:

Stage III/IV high grade serous ovarian cancer

germline and somatic BRCA testing, and HRD status

Exclusion Criteria:
Results:

(2) vs control:

median PFS, BRCAm: 34.7 vs 22 mos (SS)

median PFS, HRD: 31.9 vs 20.5 mos (SS)

(1) vs control:

median PFS, BRCAm: 21.1 vs 22 mos (NS)

median PFS, HRD: 18.1 vs 20.5 mos (NS)

Conclusions:

Veliparib administered concomitantly with chemotherapy and continued as maintenance therapy resulted in significantly longer PFS in women with advanced stage ovarian cancer.

Reviewer:
Courtney Griffiths, OTF