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Proffered Paper session 1

140O - Veliparib plus carboplatin-paclitaxel in patients with HER2-negative advanced/metastatic gBRCA-associated breast cancer: Results in hormone receptor-positive and triple-negative breast cancer subgroups from the phase III BROCADE3 trial

Date

23 May 2020

Session

Proffered Paper session 1

Presenters

Jean-Pierre Ayoub

Citation

Annals of Oncology (2020) 31 (suppl_2): S62-S82. 10.1016/annonc/annonc122

Authors

J. Ayoub1, M.L. Friedlander2, V.C. Dieras3, H. Wildiers4, B. Arun5, H.S. Han6, S. Puhalla7, Y. Shparyk8, E.H. Jakobsen9, M.G. Kundu10, M. Wu10, C. Ratajczak11, D. Maag11, B. Kaufman12

Author affiliations

  • 1 Oncology Dept., Centre Hospitalier de l'Université de Montréal, QC H2X 0C1 - Montreal/CA
  • 2 Prince Of Wales Clinical School, University of New South Wales and Prince of Wales Hospital, Sydney/AU
  • 3 Medical Oncology, Centre Eugène - Marquis, 35042 - Rennes/FR
  • 4 Department Of General Medical Oncology, University Hospitals Leuven, Leuven/BE
  • 5 Breast Medical Oncology And Clinical Cancer Genetics, The University of Texas MD Anderson Cancer Center, 77030 - Houston/US
  • 6 Department Of Breast Oncology, Moffitt Cancer Center, Tampa/US
  • 7 Upmc Cancer Centers, UPMC School of Medicine, Pittsburgh/US
  • 8 Department Of Chemotherapy, Lviv State Regional Cancer Treatment and Diagnostic Center, 79031 - Lviv/UA
  • 9 Vejle Hospital Sygehus Lillebaelt, Vejle Sygehus, 7100 - Vejle/DK
  • 10 Data And Statistical Sciences, AbbVie Inc., North Chicago/US
  • 11 Global Oncology Development, AbbVie Inc., North Chicago/US
  • 12 Sackler Faculty Of Medicine, Tel Aviv University, Tel Aviv-Yafo/IL
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Abstract 140O

Background

In BROCADE3 (NCT02163694), addition of the PARP1/2 inhibitor veliparib (Vel) to carboplatin-paclitaxel (C-P) significantly prolonged progression-free survival (PFS) in patients (pts) with HER2-negative locally advanced/metastatic gBRCA-associated breast cancer (BC; hazard ratio=0.71 [95% CI 0.57, 0.88], P=.002). Here we report efficacy and safety in hormone receptor-positive (HR+) and triple-negative BC (TNBC) subgroups separately.

Methods

Pts with ≤2 prior lines of cytotoxic therapy for metastatic BC were randomized 2:1 to Vel (120 mg PO BID) + C-P or placebo (Pbo) + C-P. Vel-Pbo was given on days (d) –2 to 5, C (AUC 6 mg/mL/min IV) on d 1, and P (80 mg/m2 IV) on d 1, 8, and 15 (21-d cycles). Pts who discontinued C and P prior to progression (at investigator discretion) received blinded single-agent Vel or Pbo (300–400 mg BID) until progression. Primary endpoint was investigator-assessed PFS. Analysis of PFS in subgroups defined by hormone receptor status was preplanned. Analyses of PFS and overall survival (OS) were stratified by prior platinum status.

Results

Among the 509 pts in the intent-to-treat population, 266 (52%) were HR+ and 243 (48%) had TNBC. PFS and OS results in each subgroup are presented in the table below. Adverse events (not related to progression) led to study drug discontinuation in 8.0%/3.3% of HR+ pts and 10.5%/7.5% of TNBC pts in the Vel + C-P and Pbo + C-P arms, respectively. Table: 140O

HR+ SubgroupN=266 TNBC SubgroupN=243
Veliparib + C-P n=174 Placebo + C-P n=92 Veliparib + C-P n=163 Placebo + C-P n=80
mPFS per INV, mo (95% CI) 13.0 (12.1, 16.6) 12.5 (10.2, 13.2) 16.6 (12.3, 22.7) 14.1 (11.0, 15.8)
PFS hazard ratio (95% CI)P value a 0.69 (0.52, 0.93).013 0.72 (0.52, 1.00).051
PFS rate at 2 years, % (95% CI) 27.5 (20.6, 34.8) 15.3 (8.2, 24.5) 40.4 (32.3, 48.4) 25.0 (15.3, 35.9)
PFS rate at 3 years, % (95% CI) 17.5 (11.2, 25.0) 8.6 (3.3, 17.0) 35.3 (27.2, 43.6) 13.0 (5.3, 24.2)
mPFS per BICR, mo (95% CI) 18.7 (14.5, 22.9) 12.6 (11.4, 16.5) 21.0 (16.0, 29.3) 14.5 (12.5, 19.7)
PFS hazard ratio (95% CI) 0.68 (0.48, 0.97) 0.71 (0.49, 1.03)
PFS rate at 2 years, % (95% CI) 39.5 (30.6, 48.2) 25.5 (13.9, 39.0) 47.4 (38.3, 56.0) 29.0 (17.7, 41.3)
PFS rate at 3 years, % (95% CI) 35.1 (26.0, 44.3) 18.6 (8.1, 32.4) 39.7 (30.2, 48.9) 20.9 (9.5, 35.3)
mOS (mo, 95% CI) [interim] 32.4 (26.5, 37.9) 27.1 (22.9, 35.2) 35.0 (24.9, NR) 30.0 (24.5, NR)
OS hazard ratio (95% CI) 0.96 (0.68, 1.36) 0.92 (0.62, 1.36)
a

On the basis of stratified log-rank test. P values are nominal. BICR, blinded independent central review; C-P, carboplatin plus paclitaxel; ER, estrogen receptor; HR+, hormone receptor positive (ER and/or PgR); INV, investigator; m, median; NR, not reached; OS, overall survival; PFS, progression-free survival; PgR, progesterone receptor; TNBC, triple-negative breast cancer.

Conclusions

The addition of Vel to C-P improved PFS in gBRCA pts with HR+ BC and TNBC. In both subgroups, benefit of Vel was durable with an increase in proportion of pts progression free at 2 and 3 years compared with Pbo.

Clinical trial identification

NCT02163694.

Editorial acknowledgement

Medical writing support was provided by Mary L. Smith, PhD, CMPP, from Aptitude Health, Atlanta, GA, and funded by AbbVie.

Legal entity responsible for the study

AbbVie Inc.

Funding

AbbVie Inc.

Disclosure

J-P. Ayoub: Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Boston Biomedical; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Eisai; Advisory/Consultancy: Eli Lilly; Advisory/Consultancy: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy: Puma; Advisory/Consultancy: Roche. M.L. Friedlander: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy, Inc. Steering Committee: MSD; Advisory/Consultancy, Non-remunerated activity/ies: AbbVie; Honoraria (self), Advisory/Consultancy: Lilly; Honoraria (self), Advisory/Consultancy: Takeda; Honoraria (self), Advisory/Consultancy: Novartis; Research grant/Funding (self): BeiGene. V.C. Dieras: Advisory/Consultancy: Roche/Genentech; Advisory/Consultancy: Novartis; Advisory/Consultancy: Lilly; Advisory/Consultancy: Pfizer; Advisory/Consultancy: AbbVie; Advisory/Consultancy: MSD; Advisory/Consultancy: Daiichi Sankyo; Advisory/Consultancy: Seattle Genetics; Advisory/Consultancy: AstraZeneca. H. Wildiers: Honoraria (institution): Roche/Genentech; Honoraria (institution): AstraZeneca; Honoraria (institution): Amgen; Honoraria (institution): Lilly; Honoraria (institution): Novartis; Honoraria (institution): AbbVie; Honoraria (institution): Vifor Pharma; Honoraria (institution), Travel/Accommodation/Expenses: Pfizer; Honoraria (institution): Celldex Therapeutics; Honoraria (institution): Janssen-Cilag; Honoraria (institution): TRM Oncology; Honoraria (institution): PUMA Biotechnology; Honoraria (institution): Orion Corporation; Research grant/Funding (institution): Roche; Travel/Accommodation/Expenses: Roche. B. Arun: Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): PharmaMar; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Invitae; Non-remunerated activity/ies: AbbVie. H.S. Han: Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Prescient; Research grant/Funding (institution): Horizon; Research grant/Funding (institution): Karyopharm; Research grant/Funding (institution): BMS; Research grant/Funding (institution): Novartis; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Tesaro; Research grant/Funding (institution): TapImmune; Research grant/Funding (institution): Seattle Genetics; Research grant/Funding (institution), Grant: Department of Defense; Speaker Bureau/Expert testimony: Lilly. S. Puhalla: Advisory/Consultancy, Research grant/Funding (institution): AbbVie; Advisory/Consultancy: MedImmune; Advisory/Consultancy: Celldex; Advisory/Consultancy: Puma; Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Advisory/Consultancy: Eisai; Advisory/Consultancy: NanoString; Research grant/Funding (institution): Lilly; Research grant/Funding (institution): Novartis; Research grant/Funding (institution): Incyte; Research grant/Funding (institution): Covance-Bayer; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): Medivation. Y. Shparyk: Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self): Roche; Honoraria (self): AstraZeneca; Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Roche; Research grant/Funding (institution): MSD; Research grant/Funding (institution): Boehringer Ingelheim. E.H. Jakobsen: Advisory/Consultancy: Pfizer; Advisory/Consultancy: Novartis; Advisory/Consultancy: Roche; Advisory/Consultancy: Lilly; Advisory/Consultancy: Puma; Non-remunerated activity/ies, principal investigator BROCADE3 trial: AbbVie. M.G. Kundu: Shareholder/Stockholder/Stock options, Full/Part-time employment: AbbVie. M. Wu: Shareholder/Stockholder/Stock options, Full/Part-time employment: AbbVie. C. Ratajczak: Shareholder/Stockholder/Stock options, Full/Part-time employment: AbbVie. D. Maag: Shareholder/Stockholder/Stock options, Full/Part-time employment: AbbVie. B. Kaufman: Advisory/Consultancy: Roche; Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Lilly; Honoraria (self), Advisory/Consultancy: Pfizer; Advisory/Consultancy: AbbVie; Advisory/Consultancy: Tesaro; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self): Roche; Honoraria (self), Steering committee: AbbVie.

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