ESMO 2020 | ASCENT trial: sacituzumab govitecan for TNBC
Aditya Bardia, MD, MPH, Massachusetts General Hospital, Boston, MA, discusses the results from the ASCENT trial (NCT02574455). This trial is a randomized Phase III study which investigates the efficacy of sacituzumab govitecan (SG) vs treatment of physician’s choice (TPC) in patients with previously treated metastatic triple-negative breast cancer (TNBC). This study met its primary end point of progression-free survival. This interview was recorded via an online conference call with The Video Journal of Oncology (VJOncology).
Transcript (edited for clarity)
The ASCENT is a phase three randomized clinical trial, evaluating the efficacy of sacituzumab govitecan, was this treatment of physician’s choice in patients with previously treated metastatic breast cancer. The rationale for the study is that patients who have metastatic triple-negative breast cancer have a poor prognosis. And the response rate with standard chemotherapy in this setting is in the range of 10% or so with a median progression-free survival of about two months, thus clinically, there’s an unmet need for better treatments for patients with metastatic triple-negative breast cancer...
The ASCENT is a phase three randomized clinical trial, evaluating the efficacy of sacituzumab govitecan, was this treatment of physician’s choice in patients with previously treated metastatic breast cancer. The rationale for the study is that patients who have metastatic triple-negative breast cancer have a poor prognosis. And the response rate with standard chemotherapy in this setting is in the range of 10% or so with a median progression-free survival of about two months, thus clinically, there’s an unmet need for better treatments for patients with metastatic triple-negative breast cancer. sacituzumab govitecan is a novel antibody-drug conjugate. The antibody targets Trop-2 which is overexpressed in triple-negative breast cancer. It has a hydrolysable linker and it’s linked to SN-38, which is a topoisomerase inhibitor and the active metabolite of irinotecan. The drug also has a bystander effect and by the bystander effect, the SN-38 is released extracellularly and can affect other cells in the tumor microenvironment.
So at ESMO 2020 we presented the results from the phase three trial, the ASCENT trial, looking at sacituzumab govitecan versus treatment of physician’s choice for patients with relapse/refractory metastatic triple-negative breast cancer. The eligibility included patients with metastatic triple-negative breast cancer who had received at least two prior lines of chemotherapy for advanced disease. The primary endpoint of the study was progression-free survival. So what did the results show? The study was positive.
It showed that patients who received sacituzumab govitecan had a superior progression-free survival as compared to standard chemotherapy. Patients who received sacituzumab govitecan had a median progression-free survival of 5.6 months as compared to 1.7 months with standard chemotherapy and this corresponded to a hazard ratio of 0.41. And this was highly statistically significant with a p-value of less than 0.001. We also looked at overall survival and similar to progression-free survival. We saw a benefit with sacituzumab govitecan versus standard chemotherapy. Patients who received and had a median overall survival of 12.1 months as compared to 6.7 months with standard chemotherapy and this corresponded to a hazard ratio of 0.4, that was both clinically meaningful and statistically significant. In other words, there was a doubling of overall survival with sacituzumab govitecan.
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