MedicalResearch.com Interview with:
Aditya Bardia, MBBS, MPH
Director, Precision Medicine, Center for Breast Cancer,
Massachusetts General Hospital Cancer Center
Harvard Medical School
Boston, MA 02114
MedicalResearch.com: What is the background for this study?
Response: Metastatic triple negative breast cancer is associated with aggressive tumor biology, and tends to affect younger patients and African Amerians. The response rate with standard chemotherapy regimens in patients with pre-treated metastatic TNBC ranges from 10-15%, and median progression-free survival ranges from 3-4 months. The median survival of metastatic TNBC is around 12 months and has not changed in the past 20 years. Thus, treatment of metastatic triple negative breast cancer represents an unmet clinical need.
MedicalResearch.com: What are the main findings?
Response: In this study of patients with metastatic triple negative breast cancer, who were heavily pre-treated, the overall response rate was 33.3 % based on local assessment and 34.3% based on blinded independent central review (BICR). The median duration of response of 7.7 months (local assessment) and 9.1 months (BICR), and median PFS of 5.5 months was noted.
Efficacy was observed in patients who had received prior taxanes and anthracyclines, suggesting a lack of cross-resistance to previous cytotoxic chemotherapy. Treatment duration with sacituzumab govitecan (5.1 months) was longer than with the immediate prior anti-tumor therapy (2.5 months), providing further evidence of clinical activity in patients with difficult-to-treat mTNBC.
The major adverse effects, included neutropenia (low white blood cell count), nausea, and diarrhea, which were reversible and manageable with supportive therapy and dose-interruptions/reductions. Peripheral neuropathy, which is a common adverse event with chemotherapy such as taxanes, platinums, and Eribulin, was not observed with this study, likely because of the SN-38 payload which targets topi-isomerase-I, as opposed to microtubules. Taxanes and Eribulin target microtubules which likely contributes towards peripheral neuropathy.
MedicalResearch.com: What should readers take away from your report?
Response: Future studies are needed to evaluate combination therapy with sacituzumab govitecan based backbone, as well as evaluate efficacy of sacituzumab govitecan monotherapy in other solid tumors.
Consulting or advisory roles with Genentech/Roche, Immunomedics, Novartis, Pfizer, Merck, Radius Health, Spectrum Pharma, and Taiho Pharma; institutional research funding from Novartis, Pfizer, Genentech, Merck, Radius Health, Immunomedics, Mersana Pharma; and a research grant from Biotheranostics.
Aditya Bardia, M.D., Ingrid A. Mayer, M.D., Linda T. Vahdat, M.D., M.B.A., Sara M. Tolaney, M.D., M.P.H., Steven J. Isakoff, M.D., Ph.D., Jennifer R. Diamond, M.D., Joyce O’Shaughnessy, M.D., Rebecca L. Moroose, M.D., Alessandro D. Santin, M.D., Vandana G. Abramson, M.D., Nikita C. Shah, M.D., Hope S. Rugo, M.D., et al
February 21, 2019
N Engl J Med 2019; 380:741-751
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