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William J. Gradishar, MD, FACP, FASCO
William J. Gradishar, MD, FACP, FASCO
Posted: Wednesday, June 5, 2024
Binghe Xu, MD, PhD, of Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China, and colleagues evaluated the efficacy of sacituzumab tirumotecan—a TROP2 antibody drug conjugate—compared with chemotherapy in patients with advanced triple-negative breast cancer and high TROP2 expression. Presented during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 104), the results of the OptiTROP-Breast01 study (ClinicalTrials.gov identifier NCT05347134) demonstrated “statistically significant and clinically meaningful” progression-free survival and overall survival benefit over chemotherapy.
This phase III trial enrolled 263 patients with locally recurrent or metastatic triple-negative breast cancer who received at least two prior therapies, with at least one in the metastatic setting. Participants were randomly assigned on a 1:1 basis to receive sacituzumab tirumotecan (n = 130) or chemotherapy (n = 133).
The primary endpoint of progression-free survival was met, with a 69% reduction in the risk of disease progression or death in patients treated with sacituzumab tirumotecan compared with chemotherapy (P < .00001). Median progression-free survival was 5.7 and 2.3 months in the sacituzumab tirumotecan and chemotherapy groups, respectively; the 6-month rates were 43.4% and 11.1%, respectively. This benefit was substantial among patients with a TROP2 H-score higher than 200 who received sacituzumab tirumotecan vs chemotherapy (5.8 vs 1.9 months).
At a median follow-up of 10.4 months, overall survival was significantly improved with sacituzumab tirumotecan vs chemotherapy (P = .0005); median overall survival was not reached and 9.4 months, respectively. Additionally, the objective response rate was significantly higher in the sacituzumab tirumotecan group (43.8%) compared with the chemotherapy group (12.8%).
The safety profile of this antibody-drug conjugate was reported to be “manageable” in this heavily pretreated population. Of note, the most common grade 3 or higher treatment-related adverse events were decreased white blood cell count, anemia, and decreased neutrophil count.
Disclosure: Dr. Xu reported no conflicts of interest. For full disclosures of the other study authors, visit coi.asco.org.
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