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.
Leslie Reviews Relevant Data for Treatment of Relapsed/Refractory CLL
May 8th 2024During a Case-Based Roundtable® event, Lori A. Leslie, MD, discussed Bruton tyrosine kinase inhibition options for a patient with relapsed/refractory chronic lymphocytic leukemia in the first article of a 2-part series.
Read More
Breast Cancer Leans into the Decade of Antibody-Drug Conjugates, Experts Discuss
September 25th 2020In season 1, episode 3 of Targeted Talks, the importance of precision medicine in breast cancer, and how that vitally differs in community oncology compared with academic settings, is the topic of discussion.
Listen
NGS and ctDNA Considered in Advanced Breast Cancer After Progression
May 3rd 2024During a Case-Based Roundtable® event, Ruth M. O'Regan, MD, led a discussion on whether to order next-generation sequencing and/or circulating tumor DNA testing for a patient with hormone receptor–positive breast cancer after progression in the first article of a 2-part series.
Read More
Comparing Choices for IO/TKI Combinations in Advanced RCC
May 2nd 2024During a Case-Based Roundtable® event, Shilpa Gupta, MD, led a discussion on the combination of immunotherapy and tyrosine kinase inhibitors for patients with advanced renal cell carcinoma in the second article of a 2-part series.
Read More