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Veliparib Added to Front-Line Chemotherapy Improves PFS in Ovarian Cancer
Barcelona, Spain—Veliparib added induction chemotherapy, followed by veliparib maintenance, significantly prolongs progression-free survival (PFS) over chemotherapy alone in women with high-grade serous ovarian carcinoma, according to results from the phase 3 VELIA study.
Results of the study were presented by Robert Coleman, MD, The University of Texas MD Anderson Cancer Center, Houston, at the ESMO 2019 Congress.
The VELIA study evaluated the efficacy of veliparib plus first-line induction chemotherapy with carboplatin and paclitaxel and continued as maintenance monotherapy in newly diagnosed high grade serous ovarian carcinoma.
A total of 1140 patients were randomized in a 1:1:1 ratio to chemotherapy plus placebo then placebo maintenance (Arm 1); chemotherapy plus veliparib then placebo maintenance (Arm 2); and chemotherapy plus veliparib then veliparib maintenance (Arm 3). Combination chemotherapy was administered for 6 cycles and maintenance therapy was administered for 30 additional cycles.
The primary end point was investigator-assessed PFS in Arm 3 compared to Arm 1 using hierarchical testing in BRCA mutations, HRD, and the intention-to-treat (ITT) populations.
Among those with BRCA-mutations, the median PFS was 34.7 months in Arm 3 compared with 22 months in Arm 1 (HR=0.44; 95% confidence interval [CI], 0.28-0.68; P<0.001). Among those with HRD, the median PFS was 31.9 months versus 20.5 months, respectively (HR= 0.57; 95 CI, 0.43-0.76; P<0.001).
In the intention-to-treat population, the median PFS was 23.5 months in Arm 3 compared with 17.3 months in Arm 1 (HR, 0.68; 95% CI, 0.56-0.83; P<0.001).
Incidence of anemia, thrombocytopenia, nausea, and fatigue were higher with veliparib combrined with chemotherapy.
“Across all trial populations, a regimen of carboplatin, paclitaxel, and veliparib induction therapy followed by veliparib maintenance therapy led to significantly longer progression-free survival than carboplatin plus paclitaxel induction therapy alone,” Dr Coleman concluded, noting that the independent value of adding veliparib during induction therapy without veliparib maintenance was less clear.—Janelle Bradley
Coleman RL, Fleming GF, et al. VELIA/GOG-3005: Integration of veliparib (V) with front-line chemotherapy and maintenance in women with high-grade serous carcinoma of ovarian, fallopian tube, or primary peritoneal origin (HGSC). Presented at: ESMO 2019 Congress; September 27-October 1, 2019; Barcelona, Spain. Abstract LBA3.
