Erika P. Hamilton, MD, discusses the updated safety analysis of the DESTINY-Breast03 trial and the patients who were enrolled in the study.
Erika P. Hamilton, MD, lead investigator and director of the Breast and Gynecologic Cancer Research Program at the Sarah Cannon Research Institute/Tennessee Oncology, discusses the updated safety analysis of the DESTINY-Breast03 trial (NCT03529110) and the patients who were enrolled in the study.
Hamilton presented findings of the DESTINY-Breast03 trial at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. During her session, she compared the safety of trastuzumab deruxtecan (Enhertu) with trastuzumab emtansine (TDM-1) for patients with HER2-positive unresectable or metastatic breast cancer.
In the trial, patients were randomized in a 1:1 ratio to receive either trastuzumab deruxtecan (n = 257) or trastuzumab emtansine (n = 261). While the efficacy data from the study was from a primary data cutoff of May 21, 2021, the updated safety findings were from a cutoff of September 7, 2021.
Transcription:
0:08 | This was the safety update for DESTINY-Breast03. As you recall, trastuzumab deruxtecan was initially approved based on DESTINY-Breast01 [NCT03248492]. DESTINY-Breast03 was a study that brought it up into an earlier-line setting, so patients that had seen trastuzumab and/or a taxane in the metastatic setting or relapsed within 6 months of neoadjuvant or adjuvant therapy. Based on DESTINY-Breast03, trastuzumab deruxtecan got a new expanded indication in earlier-line settings in May 2022.
0:42 | As opposed to the plenary [session], where DESTINY-Breast04 [NCT03734029] looked at patients who had HER2-low expression [and unresectable and/or metastatic breast cancer], this was a study of that 15% to 20% of patients with breast cancer who we know have too high [expression]. That's 3+ by immunohistochemistry, or fluorescence in situ hybridization–positive.
1:01 | This study, opposed to DESTINY-Breast01 that was with very heavily pretreated patients, looked at patients in the so-called second-line setting. They had seen trastuzumab and a taxane in the metastatic setting or relapsed within 6 months of receiving HER2 directed therapy in the neoadjuvant or adjuvant setting.
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