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William J. Gradishar, MD, FACP, FASCO
William J. Gradishar, MD, FACP, FASCO
Posted: Tuesday, September 12, 2023
The Lancet has published the final analysis of overall survival in the phase III TROPiCS-02 trial of sacituzumab govitecan-hziy in patients with hormone receptor–positive, HER2-negative metastatic breast cancer. According to to Sara M. Tolaney, MD, MPH, of Dana-Farber Cancer Institute, Boston, and colleagues, the TROP-2–directed antibody-drug conjugate demonstrated a statistically significant improvement in overall survival compared with chemotherapy, as well as prolonged quality of life and a manageable safety profile consistent with previous reports.
“These data reinforce that sacituzumab govitecan is leading to improvements in both progression-free and overall survival and that patients saw benefit irrespective of their tumor’s TROP-2 expression,” said Dr. Tolaney in a Dana-Farber press release. “This updated analysis continues to support sacituzumab govitecan as a standard treatment for patients with pretreated, endocrine-resistant hormone receptor–positive, HER2-negative metastatic breast cancer.”
A total of 543 patients took part in the randomized, open-label trial—spanning 91 centers across North America and Europe—of whom 272 were randomly assigned to receive sacituzumab govitecan, and the remaining 271 received chemotherapy. The investigators found that overall survival was 14.4 months with sacituzumab govitecan versus 11.2 months with chemotherapy, and this survival benefit was consistent across TROP-2 expression level subgroups. They also observed superior response rates and prolonged median progression-free survival among those who received sacituzumab govitecan, noting a 34% lower risk of cancer progression or death than among those treated with chemotherapy.
On the basis of these findings, sacituzumab govitecan has been approved in the United States and the European Union for patients who fit this profile who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. Further study with longer follow-up is planned.
Disclosure: For full disclosures of the study authors, visit thelancet.com.
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