ASCENT Trial: Antibody-Drug Conjugate Improves Outcomes in Triple-Negative Breast Cancer
Posted: Monday, June 21, 2021
Antibody-drug conjugate (ADC) therapy may improve the prognosis for many patients with refractory metastatic triple-negative breast cancer, according to results from the multicenter phase III ASCENT trial. Specifically, the ADC sacituzumab govitecan-hziy nearly doubled overall survival in this patient population compared with single-agent chemotherapy. However, both myelosuppression and diarrhea occurred more often with the ADC therapy. These findings were published in The New England Journal of Medicine.
“We believe antibody-drug conjugates are particularly promising as building blocks for effective new combination treatments,” stated study author Aditya Bardia, MD, MPH, of Massachusetts General Cancer Center, Boston, in an institutional press release. “The goal is to not only improve patient outcomes, but also to establish ADCs as first-line therapy or even earlier so that these powerful agents can play a role in preventing the spread of triple-negative breast cancer.”
Patients without brain metastases who had relapsed or refractory metastatic triple-negative breast cancer following two or more previous standard chemotherapy regimens were enrolled (n = 468). Patients were randomly assigned to receive either sacituzumab govitecan or single-agent chemotherapy of the physician’s choice (eribulin, vinorelbine, capecitabine, or gemcitabine). Clinical endpoints were determined through blinded independent central review.
The median progression-free survival in patients who received sacituzumab govitecan was reported to be significantly longer (5.6 months) than that with single-agent chemotherapy (1.7 months, P < .001). Similarly, overall survival was nearly doubled with sacituzumab govitecan therapy (12.1 months) compared with chemotherapy (6.7 months; P < .001). Further, patients in the sacituzumab govitecan group achieved an objective response rate of 35%, compared with 5% in the chemotherapy group.
The most common treatment-related adverse events of grade 3 or higher associated with the ADC were neutropenia, leukopenia, diarrhea, anemia, and febrile neutropenia. No deaths were directly attributed to sacituzumab govitecan treatment.
Disclosure: For full disclosures of the study authors, visit nejm.org.