Final ASCENT Trial Results: Sacituzumab Govitecan vs Chemotherapy in Triple-Negative Breast Cancer

By: Chris Schimpf, BS
Posted: Wednesday, May 22, 2024

The antibody-drug conjugate (ADC) sacituzumab govitecan-hziy appears to be more effective than single-agent chemotherapy in treating metastatic triple-negative breast cancer, according to the final results of the international, multicenter, phase III ASCENT clinical trial, published in the Journal of Clinical Oncology. Aditya Bardia, MD, MPH, of the Massachusetts General Hospital Cancer Center at Harvard Medical School, Boston, and colleagues reported the first-in-class anti–trophoblast cell surface antigen 2 (Trop-2) ADC treatment demonstrated superior efficacy over treatment with physician’s choice of single-agent chemotherapy, and its safety profile was manageable.

“These data reinforce sacituzumab govitecan as a standard-of-care treatment option in pretreated metastatic triple-negative breast cancer,” the researchers noted. “Sacituzumab govitecan is currently recommended in major guidelines for treating patients with metastatic triple-negative breast cancer who received at least two previous therapies (at least one in the metastatic setting) owing to the significant clinical benefit observed in the phase III ASCENT study.”

A total of 529 patients were randomly assigned to receive either sacituzumab govitecan (n = 267) or treatment with single-agent chemotherapy (n = 262) until unacceptable toxicity or disease progression. Upon final analysis, the investigators reported that sacituzumab govitecan improved median progression-free survival (4.8 vs 1.7 months; hazard ratio [HR] = 0.41; 95% confidence interval [CI] = 0.33–0.52) and median overall survival (11.8 vs 6.9 months; HR = 0.51; 95% CI = 0.42–0.63). Improved progression-free survival was also observed with sacituzumab govitecan vs single-agent chemotherapy in each Trop-2 expression quartile, and a trend for improved overall survival was observed across quartiles. Up to 5% of patients experienced treatment-related discontinuations from adverse events; there were no treatment-related deaths, and the safety profile was consistent across all subgroups, the study authors noted.

Disclosure: For full disclosures of the study authors, visit ascopubs.org.

Journal of Clinical Oncology

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