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Sacituzumab Govitecan-hziy in Heavily Pretreated, Metastatic Triple-Negative Breast Cancer

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Key Points

  • Objective response was observed in 33% of patients.
  • Median duration of response was 7.7 months.

In a phase I/II trial reported in The New England Journal of Medicine, Bardia et al found durable responses with the antibody-drug conjugate sacituzumab govitecan-hziy in patients with heavily pretreated, metastatic triple-negative breast cancer. The monoclonal antibody sacituzumab targets the human trophoblast cell-surface antigen 2 (Trop-2).

In the multicenter study, 108 patients who had received at least 2 prior therapies for metastatic disease received sacituzumab govitecan-hziy given intravenously at 10 mg/kg on days 1 and 8 of 21-day cycles until disease progression or unacceptable toxicity. Patients had received a median of 3 prior therapies (range = 2–10).

Treatment Response

On investigator assessment, the objective response rate was 33.3% (3 complete and 33 partial responses) and median duration of response was 7.7 months. The clinical benefit rate was 45.4%.

On post hoc independent central review, the response rate was 34.3% and median duration of response was 9.1 months. Median progression-free survival was 5.5 months, and median overall survival was 13.0 months.

Adverse Events

Grade 3 or 4 adverse events occurred in 85% of patients, with the most common being neutropenia (42%), anemia (11%), and decreased white blood cell count (11%). Febrile neutropenia occurred in 9% of patients.

Serious adverse events occurred in 32%, with the most common being febrile neutropenia (7%) and vomiting (6%). Adverse events led to treatment discontinuation in 3%. Adverse events led to death in 4 patients.

The investigators concluded, “Sacituzumab govitecan-hziy was associated with durable objective responses in patients with heavily pretreated metastatic triple-negative breast cancer. Myelotoxic effects were the main adverse reactions.”

Disclosure: The study was funded by Immunomedics. The study authors' full disclosures can be found at nejm.org.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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