Sacituzumab Shows Consistent PFS and OS Benefit in mTNBC
Ruta D. Rao, MD, discussed the trial design and final efficacy results of the ASCENT trial of sacituzumab govitecan in patients with metastatic triple-negative breast cancer.
Ruta D. Rao, MD, director, Coleman Foundation Comprehensive Breast Cancer Clinic, medical director of Rush University Cancer Center, and associate professor at Rush Medical College, discussed the trial design and final efficacy results of the ASCENT trial (NCT02574455) of sacituzumab govitecan (Trodelvy) in patients with metastatic triple-negative breast cancer (TNBC).
The phase 3 ASCENT trial enrolled patients who had received at least 2 prior lines of therapy, including a taxane, to receive sacituzumab or a single-agent chemotherapy of physician’s choice, which could be eribulin (Halaven), vinorelbine (Navelbine), capecitabine (Xeloda), or gemcitabine. The primary end point was progression-free survival (PFS).
The results were initially published in 2021, but final data were presented in 2022. This showed a median PFS of 4.8 months for sacituzumab versus 1.7 months for physician’s choice (HR: 0.41; P < .0001), as well as a median overall survival of 11.8 months for sacituzumab versus 6.9 months for patients on physician’s choice chemotherapy (HR: 0.51; P < .0001). These data were consistent with the original publication, which led to the approval of sacituzumab for patients with metastatic TNBC.
TRANSCRIPTION:
0:08 | The ASCENT trial was a randomized phase 3 trial, and these were patients who had metastatic TNBC, and they were [randomly assigned] to receive either sacituzumab or single-agent chemotherapy of physician's choice. And those chemotherapy agents could be eribulin, vinorelbine, capecitabine, or gemcitabine. The primary end point for this trial was PFS. These patients, to be eligible to the trial, had relapsed or refractory metastatic breast cancer that had progressed on 2 or more prior regimens, and they had to have received a taxane either in the early stage or metastatic setting.
1:08 | The trial led [then] to the approval of sacituzumab for TNBC based on meeting its primary end point; it showed an improvement in median PFS. The most recent data showed that the median PFS was 1.7 months for the group of patients who received treatment of physician's choice compared [with] 4.8 months for those who received sacituzumab with a HR of 0.41. [Median] OS was improved by about 5 months from 6.9 [months] to 11.8 months.
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