Final OS Analysis Shows Benefit of Sacituzumab Govitecan in HR+/HER2- mBC

Sara Tolaney, MD, MPH, associate director of the Susan F. Smith Center for Women’s Cancers; director of Clinical Trials, Breast Oncology; and senior physician at Dana-Farber Cancer Institute, and assistant professor of medicine at Harvard Medical School, discusses sacituzumab govitecan-hziy (Trodelvy) as an effective and safe treatment for patients with hormone receptor (HR)-positive/HER2-negative metastatic breast cancer.

Despite decades of advances, patients with HR-positive adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancerare in need of new treatment options. However, the FDA recently granted approval to sacituzumab govitecan based on findings from the TROPiCS-02 study (NCT03901339).

According to the final overall survival (OS) analysis of TROPiCS-02, there was a confirmed clinically meaningful OS benefit with sacituzumab govitecan compared with single-agent chemotherapy in this patient population, further supporting the FDA approval. Additionally, this analysis which was presented at ASCO 2023 reinforces the use of sacituzumab govitecan for patients with HR-positive/HER2-negative metastatic breast and deems it an effective and safe treatment.

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0:08 | At ASCO this year, we're presenting the final overall survival analysis from TROPiCS-02. This is a phase 3 trial that compared sacituzumab govitecan with treatment of physicians choice chemotherapy in patients with pretreated metastatic hormone receptor-positive breast cancer. We've previously seen data where we saw that sacituzumab did improve progression-free survival compared with chemotherapy of physicians choice. Then we saw data about overall survival, suggesting that sacituzumab did also improve overall survival compared with treatment of physicians choice.

0:41 | But now at ASCO, we're seeing the final overall survival analysis from this trial. In fact, it continues to show an improvement in progression-free survival and continues to show an improvement in overall survival, going from about 11.2 to 14.5 months. I think [these are] really robust benefits that we're seeing. We also show that these benefits, we are seeing irrespective of TROP2 H-score, as well as irrespective of HER2 IHC score. Benefits are seen across most predefined subgroups.