U.S. FDA Approves Trodelvy® in Pre-treated HR+/HER2- Metastatic Breast Cancer
On February 3rd, U.S. FDA approves of Trodelvy® (sacituzumab govitecan-hziy) for adults with pre-treated HR+/HER2- metastatic breast cancer.
First Trop-2 Directed ADC to demonstrate Overall Survival Benefit in HR+/HER2- Metastatic Breast Cancer Patients who had received prior endocrine-based therapy and at least two chemotherapies - Trodelvy has now improved survival in both pre-treated HR+/HER2- Metastatic Breast Cancer and in Second-Line Metastatic Triple-Negative Breast Cancer
The approval is based on statistically significant and clinically meaningful overall survival and progression-free survival data from the Phase 3 TROPiCS-02 study. Trodelvy is the only FDA-approved Trop-2 directed antibody-drug conjugate to have demonstrated an overall survival benefit for this patient population. In addition, Trodelvy is now also recommended as a Category 1, preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network Guidelines® (NCCN®), as defined in the Clinical Practice Guidelines in Oncology (NCCN Guidelines®).
In the TROPiCS-02 study, Trodelvy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit of 3.2 months versus comparator single-agent chemotherapy (treatment of physician’s choice; TPC) (median OS: 14.4 months vs. 11.2 months; hazard ratio [HR]=0.79; 95% CI: 0.65-0.96; p=0.02). Trodelvy also demonstrated a 34% reduction in risk of disease progression or death (median PFS: 5.5 versus 4.0 months; HR: 0.66; 95% CI: 0.53-0.83; p=0.0003). Three times as many people treated with Trodelvy were progression free at one year versus those treated with chemotherapy (21% versus 7%). In a post-hoc analysis, data demonstrated Trodelvy’s efficacy across HER2-low and IHC0 status in pre-treated metastatic breast cancer patients in the TROPiCS-02 trial.
Trodelvy also significantly improved additional secondary endpoint measures, including objective response rate and time to deterioration (TTD) assessed by the Global Health Status/Quality of Life and Fatigue scale per EORTC-QLQ-C30. No statistically significant difference in TTD in Pain Scale was observed.
Gilead press release available at this link