Progression-free survival (PFS) assessed by investigators in ovarian cancer trials is reliable, according to study findings by Carol Aghajanian, MD, Memorial Sloan Kettering Cancer Center, New York, and colleagues.

“The phase III VELIA trial demonstrated statistically significant improvement in PFS per investigator for [veliparib] added to [carboplatin plus paclitaxel] and continued as maintenance [carboplatin plus paclitaxel and veliparib] to carboplatin versus carboplatin plus paclitaxel alone in patients with newly diagnosed HGSC [high-grade serious ovarian cancer],” wrote Dr Aghajanian et al.

A total of 1140 patients were enrolled in the international, phase 3 VELIA trial, 26% of whom had BRCA mutations and 55% of whom were homologous recombination deficient (HRD). These patients were given 6 cycles of velaparib or placebo plus carboplatin and paclitaxel, as well as maintenance therapy.

The primary end point was investigator-assessed PFS, and the primary analysis of PFS by investigator compared carboplatin plus paclitaxel and velaparib with carboplatin plus paclitaxel alone in the BRCA-positive, HRD, and whole populations.

The PFS of patients with BRCA wild-type (BRCAwt) and non-HRD ovarian cancer were also analyzed, and all analyses were compared with PFS assessed per blinded independent central review (BICR) analyses.

Concordance rates between investigator-assessed PFS and BICR-assessed PFS were 68% to 85% by arm for each population. Analyses of PFS conducted via BICR and investigators were consistent, as were exploratory analyses of PFS in non-HRD and HRD, BRCAwt populations.

In all of the primary and exploratory populations assessed, PFS was prolonged in the veliparib versus placebo arm.

“Analyses of PFS per BICR supported the primary analysis of PFS per investigator in the BRCA-positive, HRD, and whole populations, as well as exploratory BRCAwt and non-HRD populations,” reported Dr Aghajanian and co-investigators.

“These findings support the reliability of PFS by investigator in ovarian cancer trials. Alternate strategies like audits may be appropriate to support PFS by investigator with less time and expense than full BICR,” they concluded.—Kaitlyn Manasterski

Aghajanian C, Bookman M, et al. PFS by blinded independent central review (BICR) in the VELIA trial of veliparib (V) plus carboplatin/paclitaxel (CP) and as monotherapy in newly diagnosed patients (pts) with high-grade serous ovarian cancer (HGSC). Presented at: the 2020 ASCO Annual Meeting; May 29-31, 2020. Abstract 6077