Sacituzumab govitecan can improve progression-free survival (PFS), when compared with chemotherapy, in patients with hormone receptor (HR)-positive, HER2-negative, endocrine-resistant breast cancer, a phase 3 study suggests.
Researchers found that sacituzumab govitecan was associated with a 34% reduction in the risk of progression or death, when compared with physician’s choice of chemotherapy. These results were published in the Journal of Clinical Oncology.
This phase 3 trial (TROPiCS-02, ClinicalTrials.gov Identifier: NCT03901339) enrolled patients with heavily pretreated, endocrine-resistant, HR+/HER2- locally recurrent inoperable or metastatic breast cancer.
Patients were randomly assigned to receive sacituzumab govitecan (n=272) or physician’s choice of chemotherapy (n=271). Chemotherapy options included eribulin (48%), vinorelbine (23%), gemcitabine (21%), and capecitabine (8%).
The median follow-up was 10.2 months. The median PFS was 5.5 months with sacituzumab govitecan and 4.0 months with chemotherapy (hazard ratio [HR], 0.66; 95% CI, 0.53-0.83; P =.0003).
PFS was higher with sacituzumab govitecan at both landmark time points. The 6-month PFS rate was 46% with sacituzumab govitecan and 30% with chemotherapy. The 12-month PFS rate was 21% and 7%, respectively.
The median overall survival at the first interim analysis was 13.9 months with sacituzumab govitecan and 12.3 months with chemotherapy (HR, 0.84; 95% CI, 0.67-1.06; P =.14). The researchers noted that these results are not yet mature, and follow-up is ongoing.
The most common grade 3 or higher treatment-related adverse events (with sacituzumab govitecan and chemotherapy, respectively) were neutropenia (51% vs 38%), leukopenia (9% vs 5%), diarrhea (9% vs 1%), anemia (6% vs 3%), and fatigue (6% vs 2%).
Disclosures: This research was supported by Gilead Sciences. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Rugo HS, Bardia A, Marme F, et al. Sacituzumab govitecan in hormone receptor–positive/human epidermal growth factor receptor 2–negative metastatic breast cancer. J Clin Oncol. Published online August 26, 2022. doi:10.1200/JCO.22.01002.