Efficacy and Safety of Front-Line Veliparib and Paclitaxel Weekly versus Every 3 Weeks in the VELIA Study

Conference Correspondent  - ESMO Highlights

In the phase 3 VELIA study, patients with high-grade serous ovarian cancer were randomized to 1 of 3 treatment options: carboplatin/paclitaxel (CP) plus placebo followed by placebo maintenance, CP plus veliparib (VEL) followed by placebo maintenance, or CP plus VEL followed by VEL maintenance. This study demonstrated a significant improvement in progression-free survival (PFS) for patients treated with CP and VEL versus those treated with CP alone. Investigators were able to choose to deliver paclitaxel one of two ways—either 175 mg/m2 intravenously every 3 weeks (Q3W) or 80 mg/m2 dose dense (DD) weekly. This exploratory analysis of the VELIA data evaluates PFS and safety by dosing regimen of paclitaxel.

Patient randomization was stratified by paclitaxel regimen, extent of residual disease, disease stage, and region. Treatment included combination therapy given for six 21-day cycles followed by 30 cycles of VEL or placebo maintenance. Of the 1132 patients in the evaluable population, 52% received DD paclitaxel, whereas 48% received Q3W paclitaxel. Median dose intensity varied somewhat across treatment arms: 95% to 99% with Q3W paclitaxel and 84% to 95% with DD paclitaxel. DD paclitaxel was associated with longer PFS when compared with Q3W paclitaxel (median, 20.5 vs 15.7 months; hazard ratio, 0.77; 95% confidence interval, 0.66-0.89). This was also true in subgroup analyses by ethnicity, for those with wild-type BRCA, and regardless of homologous recombination deficiency status. In patients with mutated BRCA, PFS did not vary by paclitaxel regimen. Patients with BRCA wild-type and homologous recombination–proficient tumors showed the greatest difference in PFS with DD paclitaxel versus Q3W paclitaxel. Regardless of paclitaxel regimen, those receiving VEL throughout their treatment achieved longer PFS than those who received CP alone.

The “as-treated” safety population for this study included 1124 patients. Those who received DD paclitaxel experienced more frequent grade 3/4 adverse events (AEs) than those who received Q3W paclitaxel. In the CP-alone arm, 90% of those receiving DD paclitaxel experienced grade 3/4 AEs versus 63% of those receiving Q3W paclitaxel. In the CP plus VEL followed by placebo maintenance arm, grade 3/4 AEs were experienced by 94% of those receiving DD paclitaxel versus 80% of those receiving Q3W paclitaxel. Finally, in the CP plus VEL followed by VEL maintenance arm, grade 3/4 AEs were experienced by 94% of those receiving DD paclitaxel versus 82% of those receiving Q3W paclitaxel. When analyzing hematologic toxicities specifically, DD paclitaxel was associated with a higher frequency of grade 3/4 events versus Q3W paclitaxel.

The authors concluded that in patients with newly diagnosed high-grade serous ovarian cancer, DD paclitaxel, regardless of treatment with VEL, was associated with longer PFS overall and also in biomarker-negative subgroups. Furthermore, DD paclitaxel was also associated with a higher frequency of grade 3/4 AEs, including hematologic toxicities, versus paclitaxel Q3W.

Reference

Abstract and Poster 818P. ESMO 2020. September 19-21, 2020. Veliparib with carboplatin and paclitaxel in frontline high-grade serous ovarian cancer (HGSOC): efficacy and safety of paclitaxel weekly and every 3 weeks in the VELIA study.

Related Items
Adjuvant Abemaciclib plus Endocrine Therapy Game-Changer in High-Risk, HR-Positive, HER2-Negative Early Breast Cancer
Phoebe Starr
Web Exclusives published on November 3, 2020 in ESMO Highlights
Trabectedin/PLD versus Carboplatin/PLD in Recurrent Ovarian Cancer Progressing within 6-12 Months After Last Platinum Line
Conference Correspondent  published on September 23, 2020 in ESMO Highlights
Safety and Efficacy of XMT-1536 in Ovarian Cancer: Subgroup Analysis from a Phase 1 Expansion Study
Conference Correspondent  published on September 23, 2020 in ESMO Highlights
Maintenance Olaparib plus Bevacizumab for Newly Diagnosed High-Grade Ovarian Cancer: Second Progression-Free Survival
Conference Correspondent  published on September 23, 2020 in ESMO Highlights
Real-World Data on Platinum Therapy in High-Grade Serous Ovarian Cancer Patients Progressing After PARP Inhibitor Treatment
Conference Correspondent  published on September 23, 2020 in ESMO Highlights
Atezolizumab in Patients with Newly Diagnosed Stage III or Stage IV Ovarian Cancer
Conference Correspondent  published on September 23, 2020 in ESMO Highlights
Mirvetuximab Soravtansine in Combination with Carboplatin and Bevacizumab in Recurrent Ovarian Cancer
Conference Correspondent  published on September 22, 2020 in ESMO Highlights
Patient-Reported Outcomes in Patients Receiving Niraparib in the PRIMA/ENGOT-OV26/GOG-3012 Trial
Conference Correspondent  published on September 22, 2020 in ESMO Highlights
Nivolumab versus Gemcitabine or Pegylated Liposomal Doxorubicin for Patients with Platinum-Resistant Ovarian Cancer: The NINJA Trial
Conference Correspondent  published on September 22, 2020 in ESMO Highlights
Individualized Starting Dose of Niraparib to Treat Platinum-Sensitive Recurrent Ovarian Cancer: The NORA Trial
Conference Correspondent  published on September 22, 2020 in ESMO Highlights
© Amplity Health. All rights reserved.

Subscribe Today!

To sign up for our newsletter or print publications, please enter your contact information below.

I'd like to receive: