ASCO 2023 | ASCENT-05: sacituzumab govitecan and pembrolizumab in TNBC
Sara Tolaney, MD, MPH, Dana-Farber Cancer Institute, Boston, MA, provides an overview of the Phase III ASCENT-05/OptimICE-RD study (NCT05633654), which aims to assess the effectiveness and safety of sacituzumab govitecan in combination with pembrolizumab compared to pembrolizumab alone or pembrolizumab with capecitabine in patients with residual disease after neoadjuvant therapy for triple-negative breast cancer (TNBC). The primary endpoint is invasive disease-free survival, while secondary endpoints include overall survival, distant disease-free survival, adverse events, laboratory abnormalities, and quality of life. The trial is currently recruiting approximately 1500 patients globally. This interview took place at the American Society of Clinical Oncology (ASCO) 2023 Annual Congress in Chicago, IL.
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Transcript (edited for clarity)
So ASCENT-05 is also known as OptimICE-RD, which is an Alliance Foundation trial being done in collaboration with Gilead, which is focused on looking at patients who have early stage, triple negative breast cancer, who received preoperative chemotherapy and have residual disease. And so this is a group of patients we know, that unfortunately has a very high risk of recurrence. And currently the standard of care for these patients is if they had received prior immunotherapy in the pre-op setting, were usually just continuing pembro out back...
So ASCENT-05 is also known as OptimICE-RD, which is an Alliance Foundation trial being done in collaboration with Gilead, which is focused on looking at patients who have early stage, triple negative breast cancer, who received preoperative chemotherapy and have residual disease. And so this is a group of patients we know, that unfortunately has a very high risk of recurrence. And currently the standard of care for these patients is if they had received prior immunotherapy in the pre-op setting, were usually just continuing pembro out back. Some people are sometimes adding capecitabine, given data from CREATE-X to that group of patients. But again, we know that they have high risk of disease recurrence. And so this study is looking to see if we could use sacituzumab in combination with pembrolizumab for that residual disease population and comparing it to giving pembrolizumab plus capecitabine per physician’s choice, really trying to see if we can prevent recurrence by use of the combination of sacituzumab and pembrolizumab in this population.
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