Dr. Bardia on Sacituzumab Govitecan in Triple-Negative Breast Cancer

Aditya Bardia, MD, MPH
Published: Tuesday, Jan 30, 2018



Aditya Bardia, MD, MPH, assistant professor of medicine, Harvard Medical School, attending physician, Medical Oncology, Massachusetts General Hospital, discusses a trial investigating sacituzumab govitecan for patients with triple-negative breast cancer (TNBC).

Sacituzumab govitecan is an antibody-drug conjugate that has an TROP-2 antibody that is linked with SN-38, which is the active metabolite of irinotecan. In February of 2016, the drug was awarded breakthrough therapy designation status by the FDA.

Patients were treated with sacituzumab govitecan on day 1 and 8 every 21 days intravenously. The main adverse event (AE) that was noticed in this trial was neutropenia. Besides neutropenia, nausea, vomiting, and diarrhea were also seen, but the incidence of grade 3 gastrointestinal AEs was in the single digits. The side effects were manageable with supportive therapy. Only 2 patients (1.8%) discontinued because of AEs and the others continued the treatment until disease progression or unacceptable toxicity.

In terms of efficacy, the observed an objective response rate (ORR) was 34%. This was a confirmed ORR in an intent-to-treat analysis. Complete responses were also noted with sacituzumab govitecan. According to Bardia, it was impressive to see the efficacy results with this agent in patients with metastatic TNBC.
 


Aditya Bardia, MD, MPH, assistant professor of medicine, Harvard Medical School, attending physician, Medical Oncology, Massachusetts General Hospital, discusses a trial investigating sacituzumab govitecan for patients with triple-negative breast cancer (TNBC).

Sacituzumab govitecan is an antibody-drug conjugate that has an TROP-2 antibody that is linked with SN-38, which is the active metabolite of irinotecan. In February of 2016, the drug was awarded breakthrough therapy designation status by the FDA.

Patients were treated with sacituzumab govitecan on day 1 and 8 every 21 days intravenously. The main adverse event (AE) that was noticed in this trial was neutropenia. Besides neutropenia, nausea, vomiting, and diarrhea were also seen, but the incidence of grade 3 gastrointestinal AEs was in the single digits. The side effects were manageable with supportive therapy. Only 2 patients (1.8%) discontinued because of AEs and the others continued the treatment until disease progression or unacceptable toxicity.

In terms of efficacy, the observed an objective response rate (ORR) was 34%. This was a confirmed ORR in an intent-to-treat analysis. Complete responses were also noted with sacituzumab govitecan. According to Bardia, it was impressive to see the efficacy results with this agent in patients with metastatic TNBC.
 

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