Drug Utilization Research / Other

6D-01 - Real-World Use and Survival Outcomes of Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer and Hormone Receptor-Positive/HER2-Negative Breast Cancer: Insights from the French Early Access Program

Tuesday, August 26, 2025

1:30 PM - 1:35 PM ET

Presenting Author(s)

Aya Elhusseiny SHAABAN, PharmD

PhD candidate - pharmacist, researcher and epidemiologist
EPI-PHARE, French National Agency for Medicine and Health Product Safety (ANSM) and the French National Health Insurance Center (CNAM), Paris Saclay University, Université Versailles Saint Quentin (UVSQ - EDSP)
Clichy, Ile-de-France, France

Co-Author(s)

HJ

Hugo Jourdain, PhD

EPI-PHARE, French National Agency for Medicine and Health Product Safety (ANSM) and the French National Health Insurance Center (CNAM)
ST DENIS, France
DD

David Desplas

EPI-PHARE, French National Agency for Medicine and Health Product Safety (ANSM) and the French National Health Insurance Center (CNAM)
ST DENIS, France
MZ

Mahmoud Zureik, PhD, MD

Professor in UVSQ Paris Saclay University, Head / Director of Epi Phare Laboratory Gis ANSM / CNAM
EPI-PHARE Scientific Interest Group in Epidemiology of Health Products from the French National Agency for the Safety of Medicines and Health Products and the French National Health Insurance, St Denis, France ; Paris Saclay University, Université Versailles Saint Quentin (UVSQ - EDSP)
ST DENIS, France
NH

Nadia Haddy, PhD, MD

EPI-PHARE, French National Agency for Medicine and Health Product Safety (ANSM) and the French National Health Insurance Center (CNAM)
ST DENIS, France

Background: Sacituzumab govitecan (SG), an antibody-drug conjugate for advanced breast cancer, received early access authorizations for third-line metastatic triple-negative breast cancer (mTNBC) in September 2021 and for hormone receptor-
positive/HER2-negative metastatic breast cancer (HR+/HER2− mBC) in February 2023. The accelerated integration of SG into clinical practice highlights the crucial need to evaluate its real-world use.

Objectives: This nationwide cohort study aimed to assess real-world SG use, patient characteristics and survival outcomes.

Methods: Using the French National Health Data System (SNDS), we identified all patients who initiated SG between July 1, 2021, and December 31, 2023, with follow-up until June 30, 2024. Patient characteristics included demographics, comorbidities, and prior treatments. Kaplan-Meier estimates were used for median time to treatment discontinuation (TTD) and median overall survival (OS), while multivariable Cox models identified prognostic factors for OS.

Results: We identified 2,527 mTNBC and 1,126 HR+/HER2− mBC patients, with median ages of 58 and 61.5 years, respectively. Both groups had a median of two metastatic sites. Median OS was 11.0 months (95% Confidence Interval [CI]: 10.4–11.7) for
mTNBC and 11.4 months (95% CI: 10.7–12.4) for HR+/HER2− mBC, with 1-year survival rates of 47.0% and 48.0%,
respectively. Median TTD was 4.3 months for mTNBC and 3.5 months for HR+/HER2− mBC. In multivariable analysis, poorer
overall survival was independently associated with inpatient initiation of SG and digestive or hepatic metastases in both
indications. In mTNBC specifically, additional adverse factors included brain metastases, respiratory disease history,
tobacco-related hospitalization, multiple metastatic sites, and prior anticancer treatments.

Conclusions: This is the largest study to highlights SG’s clinical relevance but also reflects the challenge of translating clinical trial efficacy into real-world outcomes. Median OS was longer than that in small-scale real-world studies but still shorter than in clinical trials, suggesting differences in patient selection and treatment settings. Further tolerability analyses are needed to optimize SG’s clinical use.