Sacituzumab Govitecan Approval Gives ‘Meaningful’ Survival in Advanced HR+ Breast Cancer

The approval for sacituzumab govitecan (Trodelvy) in hormone receptor (HR)-positive, HER2-negative breast cancer is “tremendous,” as it introduces a treatment option that improves disease control and patient survival compared with standard chemotherapy, according to Sara M. Tolaney, MD, MPH. 

CancerNetwork^® spoke with Tolaney, chief of the Division of Breast Oncology and associate director of the Susan F. Smith Center for Women’s Cancer at Dana-Farber Cancer Institute and associate professor of medicine at Harvard Medical School, in an interview ahead of the FDA’s approval of sacituzumab govitecan regarding how the regulatory decision may positively impact those with HR-positive disease.¹ 

The FDA’s approval was supported by data from the phase 3 TROPiCS-02 trial (NCT03901339), in which sacituzumab govitecan produced a 34% reduction in the risk of disease progression or death compared with standard of care chemotherapy.²

Additionally, the agent yielded a median progression-free survival of 5.5 months compared with 4.0 months among patients receiving chemotherapy (HR, 0.66; 95% CI, 0.53-0.83; P = .0003.) The median overall survival was 14.4 months in the experimental arm vs 11.2 months in the control arm (HR, 0.79; 95% CI, 0.65-0.96; P = .02).

Transcript:

[The approval for sacituzumab govitecan] is tremendous because hormone receptor-positive disease is the most common subtype of breast cancer. We do know that patients who have progressed on prior chemotherapy unfortunately have pretty limited options, which is really just more standard chemotherapy where we see response rates are unfortunately lower and progression-free survival is not what we want it to be.

Having an agent that can not just improve the duration of control of [patients’] disease but actually allow them to live longer is really meaningful; it is so important for patients to have more options for treatment.

References

1. U.S FDA approves Trodelvy in pre-treated HR+/HER2- metastatic breast cancer. News release. Gilead. February 3, 2023. Accessed February 3, 2023. https://bwnews.pr/3Y0bftX
2. U.S. FDA accepts for priority review the supplemental biologics license application for Gilead’s Trodelvy® for pre-treated HR+/HER2- metastatic breast cancer. News release. Gilead Sciences. October 11, 2022. Accessed February 2, 2023. Bit.ly/3YifctN