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William J. Gradishar, MD, FACP, FASCO
William J. Gradishar, MD, FACP, FASCO
Posted: Tuesday, September 17, 2024
In a study presented at the International Association for the Study of Lung Cancer (IASLC) European Society for Medical Oncology (ESMO) Congress 2024 (Abstract 344MO), researchers discussed the efficacy of a novel TROP2 antibody-drug conjugate—known as ESG401—used to treat patients with metastatic breast cancer who have brain metastases. Fei Ma, MD, of the National Cancer Center, Chinese Academy of Medical Sciences and Peking Union Medical College, and colleagues reported on the anticancer activity of this new agent.
A total of 134 patients with HER2-negative metastatic breast cancer were included in this phase Ia/b trial (ClinicalTrials.gov identifier NCT04892342). Patients with either treated/stable or new brain metastases were eligible. As of March 2024, 16 patients had efficacy-evaluable brain metastases. The dosing regimens included 6 patients treated at 12 mg/kg, 4 patients treated at 14 mg/kg, and 6 patients treated at 16 mg/kg on days 1, 8, and 15 of a 28-day cycle, respectively.
Of the 16 patients evaluated for efficacy, 9 had heavily pretreated triple-negative breast cancer, and 2 patients had treatment-naive triple-negative breast cancer. Efficacy findings revealed that two patients achieved a complete intracranial response, four had a partial intracranial response, and six had stable disease as the best intracranial response. Additionally, the intracranial disease control rate was 75% (95% confidence interval = 15.2%–64.6%). Further, the longest duration of treatment for one patient reached 17.7 months and was still ongoing at study completion. Finally, the safety profile of ESG401 appeared to be similar both in patients with and without brain metastases.
Disclosure: Dr. Ma reported no conflicts of interest. For full disclosures of the other study authors, visit cslide.ctimeetingtech.com.
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