Phase 3 trial of veliparib for high-grade serous ovarian carcinoma


  • Dawn O'Shea
  • Univadis Medical News
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New findings suggest carboplatin, paclitaxel and veliparib induction therapy, followed by veliparib maintenance therapy significantly improves progression-free survival (PFS) compared to carboplatin plus paclitaxel induction therapy alone in untreated high-grade serous ovarian carcinoma.

The international, phase 3, placebo-controlled trial randomised 1,140 patients to receive chemotherapy plus placebo followed by placebo maintenance (control), chemotherapy plus veliparib followed by placebo maintenance (veliparib combination only) or chemotherapy plus veliparib followed by veliparib maintenance (veliparib throughout).

In the BRCA-mutation cohort, median PFS was 34.7 months in the veliparib-throughout group and 22.0 months in the control group (HR for progression or death 0.44; 95% CI 0.28-0.68; P<.001 in those with homologous recombination deficiency included the>BRCA-mutation cohort), PFS was 31.9 months and 20.5 months (HR 0.57; 95 CI 0.43-0.76; P<.001 in the intention-to-treat population it was months and ci p respectively.>

Veliparib added to chemotherapy led to a higher incidence of anaemia and thrombocytopaenia and was generally associated with nausea and fatigue but did not adversely affect patients’ quality of life as reported on surveys.

The study is published in the New England Journal of Medicine.