What is the role of Sacituzumab Govitecan (Trodelvy), a novel antibody-drug conjugate, in the treatment of Triple-Negative Breast Cancer (TNBC)?

From the Guidelines

Sacituzumab govitecan (Trodelvy) is a highly effective treatment option for patients with metastatic triple-negative breast cancer (TNBC) who have received at least two prior therapies for metastatic disease, as evidenced by the ASCENT5 trial 1. The ASCENT5 trial demonstrated that sacituzumab govitecan improved progression-free survival (PFS) and overall survival (OS) compared to standard therapy in patients with metastatic TNBC, with a median PFS of 5.6 months versus 1.7 months and a median OS of 12.1 months versus 6.7 months 1. Key benefits of sacituzumab govitecan include:

• Improved PFS and OS in patients with metastatic TNBC
• Targeted mechanism of action, delivering a cytotoxic payload directly to cancer cells
• Potential for reduced systemic toxicity compared to traditional chemotherapy The standard dosing regimen for sacituzumab govitecan is 10 mg/kg administered as an intravenous infusion on days 1 and 8 of a 21-day treatment cycle, continued until disease progression or unacceptable toxicity. Common side effects of sacituzumab govitecan include:
• Neutropenia
• Diarrhea
• Leukopenia
• Anemia
• Febrile neutropenia Patients should be monitored closely for these side effects, and prophylactic medications may be recommended to prevent reactions. Regular blood count monitoring is essential, and patients should be educated about the risk of severe diarrhea, which may require prompt antidiarrheal treatment. Overall, sacituzumab govitecan represents an important treatment option for TNBC, a historically difficult-to-treat breast cancer subtype with limited targeted therapies 1.

From the FDA Drug Label

TRODELVY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with: Locally Advanced or Metastatic Breast Cancer Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.

The role of Sacituzumab Govitecan (Trodelvy) in the treatment of Triple-Negative Breast Cancer (TNBC) is for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease 2.

• Key Points:
  • Indication: Unresectable locally advanced or metastatic TNBC
  • Patient Population: Adults who have received two or more prior systemic therapies
  • Disease Status: Metastatic disease The recommended dose is 10 mg/kg once weekly on Days 1 and 8 of continuous 21-day treatment cycles until disease progression or unacceptable toxicity 2.

From the Research

Role of Sacituzumab Govitecan in TNBC Treatment

• Sacituzumab govitecan (SG) is a Trop-2-directed antibody-drug conjugate approved for patients with metastatic triple-negative breast cancer (mTNBC) who have received ≥2 prior systemic therapies 3, 4, 5, 6.
• The drug has shown promising anti-cancer activity in patients with mTNBC, with a manageable side effect profile 3, 4, 5, 6.
• The most common adverse events associated with SG are neutropenia, diarrhea, nausea, and fatigue 3, 4, 7, 6.

Efficacy of Sacituzumab Govitecan

• Studies have demonstrated that SG significantly improves progression-free survival (PFS) and overall survival (OS) in patients with mTNBC compared to single-agent chemotherapy 3, 6.
• The median PFS and OS with SG were 5.6 months and 12.1 months, respectively, compared to 1.7 months and 6.7 months with chemotherapy 6.
• The objective response rate with SG was 35%, compared to 5% with chemotherapy 6.

Safety Profile

• The safety profile of SG is characterized by myelosuppression (neutropenia, leukopenia, anemia) and gastrointestinal toxicity (diarrhea, nausea) 3, 4, 7, 6.
• The incidence of grade 3 or higher adverse events with SG includes neutropenia (51%), leukopenia (10%), diarrhea (10%), anemia (8%), and febrile neutropenia (6%) 6.
• Dose reductions or interruptions due to adverse events were common, with 39.5% of patients requiring a dose reduction or interruption 7.