09 Dec Breast Cancer: PARP Inhibitor Veliparib Has Potential To Enhance Platinum Chemotherapy in Recurrent or Metastatic Disease
MedicalResearch.com Interview with:
Vince Giranda, M.D., PH.D.
AbbVie Oncology Development
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In this Phase 2 study, called BROCADE 2, veliparib combined with the platinum chemotherapy regimen carboplatin and paclitaxel showed positive trends in overall survival (OS) and progression-free survival (PFS), although these were not statistically significant. Importantly there were no meaningful increase in side effects with the addition of veliparib to carboplatin and paclitaxel. The veliparib combination regimen also demonstrated a significantly higher objective response rate.
MedicalResearch.com: What are the main findings?
Response: Brocade 2, as a phase 2 trial with approximately 90 patients per arm, was limited in its ability to detect improvements in PFS at the p < 0.05 level of significance. The Phase 2 trial was a signal generation trial, and the positive trends we observed in OS, PFS and ORR warranted further research of veliparib in BRCA-mutated breast cancer with a Phase 3 trial, which is ongoing. The signal observed in Phase 2 also helped us determine the appropriate cohort size for Phase 3.
MedicalResearch.com: What should readers take away from your report?
Response: There hasn’t been a lot of progress in the treatment of BRCA positive breast cancer; and treatment options have been limited for this patient population, which tends to skew younger. There is a great need for new research in BRCA1 and BRCA2 mutation cancers right now, and PARP inhibitors, like veliparib, are helping to fill that gap.
This is the first Phase 2 randomized study to show that a PARP inhibitor has the potential to enhance the efficacy of platinum chemotherapy in patients with locally recurrent or metastatic breast cancer. This approach is distinct from other late-stage clinical PARP inhibitors that are focused on treating BRCA breast cancer without addition of platinum-based chemotherapy. We hope that the larger Phase 3 study provides more definitive answers on whether veliparib has the potential to become a part of routine clinical care.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: The next milestone will be the results of the Phase 3 Brocade 3 trial. As mentioned, this trial will be sufficiently sized to observe statistically significant differences in endpoints.
The BROCADE 3 trial will confirm, in a larger and statistically sized trial, what we observed in Phase 2. We are currently enrolling for the Phase 3 BROCADE trial and people interested in more information about the trial can find it at www.clinicaltrials.gov.
MedicalResearch.com: Is there anything else you would like to add?
Response: Our veliparib research has focused on use in combination with platinum based chemotherapy, which appears to produce high response rates in BRCA-associated breast cancers. This is the first Phase 2 randomized study to show that a PARP inhibitor has the potential to enhance the efficacy of platinum chemotherapy. This approach is distinct from other late-stage clinical PARP inhibitors that are focused on treating BRCA breast cancer without addition of platinum-based chemotherapy, and we hope that it provides a much needed treatment option for patients with BRCA positive breast cancer.
These veliparib data add to AbbVie’s growing body of research that has recently been shared at ASH, SNO and SABCS for potential treatments in various forms of solid tumors, including non-small cell lung cancer, small cell lung cancer, glioblastoma, breast cancer and ovarian cancer.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Disclosure: Study supported by AbbVie
Han HS, Dieras V, Robson ME, et al. Efficacy and tolerability of veliparib (V; ABT-888) in combination with carboplatin (C) and paclitaxel (P) vs placebo (Plc)+C/P in patients (pts) with BRCA1 or BRCA2 mutations and metastatic breast cancer: A randomized, phase 2 study. Paper presented at: 39th San Antonio Breast Cancer Symposium; Dec 2016; San Antonio, TX.
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.
More Medical Research Interviews on MedicalResearch.com