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William J. Gradishar, MD, FACP, FASCO


ESMO 2022: Overall Survival Update From TROPiCS-02 Trial of Sacituzumab Govitecan in Metastatic Breast Cancer

By: Sarah Campen, PharmD
Posted: Monday, September 19, 2022

Sacituzumab govitecan-hziy was reported to improve overall survival in patients with heavily pretreated hormone receptor–positive/HER2-negative (HR+/HER2–) metastatic breast cancer, according to the second interim analysis of the TROPiCS-02 trial. Treatment with the anti–TROP2 antibody-drug conjugate resulted in a median 3.2-month improvement in survival—representing a 21% relative reduction in the risk of death. Hope S. Rugo, MD, FASCO, of the University of California, San Francisco, and colleagues presented their findings at the European Society for Medical Oncology (ESMO) Congress 2022 (Abstract LBA76).

This phase III trial included 543 patients with HR+/HER2– metastatic breast cancer who had previously received taxane, endocrine-based therapy, a CDK4/6 inhibitor, and two to four prior chemotherapeutic agents; most patients (95%) had visceral metastases. Patients were randomly assigned to receive sacituzumab govitecan (n = 272) intravenously at 10 mg/kg on days 1 and 8 of a 21-day cycle or treatment of physician’s choice of chemotherapy (n = 271).

Sacituzumab govitecan significantly improved overall survival compared with physician’s choice (median 14.4 vs. 11.2 months; hazard ratio 0.79 [95% confidence interval 0.65–0.96]; P = .02). Significant improvement in objective response rate (21% vs. 14%) was also observed.

Additionally, patients who received sacituzumab govitecan reported improvements in health-related quality of life compared with the control arm. They also had a significant delay in deterioration of fatigue and global health status quality of life.

“These data support the use of sacituzumab govitecan as a novel therapy for patients with pretreated HR+/HER2– metastatic breast cancer,” concluded the authors.

Disclosure: For full disclosures of the study authors, visit

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