In this episode of Targeted Talks, Aditya Bardia, MD, MPH, FASCO, discusses the recent FDA approval of datopotamab deruxtecan in breast cancer.
In this episode of Targeted Talks, Aditya Bardia, MD, MPH, FASCO, discusses the recent FDA approval of datopotamab deruxtecan (Dato-DXd) for the treatment of patients with unresectable or metastatic hormone receptor-positive (HR+), HER2-negative (HER2–) breast cancer who have received prior systemic therapy.
0:45 | About the approval
1:16 | Dato-DXd's mechanism of action
2:00 | Behind TROPION-Breast01
3:03 | Key findings from the study
3:52 | Overall survival findings
4:57 | Future biomarkers
5:35 | Real world recommendations
7:14 | Future development of ADCs
“TROPION-Breast01 was a global phase 3 clinical trial that evaluated datopotamab deruxtecan for patients with hormone receptor-positive, HER2– metastatic breast cancer and also included patients with HER2-low disease. Patients who received datopotamab deruxtecan had a superior progression-free survival as compared with standard chemotherapy,” explains Bardia, professor, department of medicine, division of hematology/oncology, director of translational research integration, UCLA Health Jonsson Comprehensive Cancer Center, Los Angeles, CA, in the interview with Targeted OncologyTM.
Data from the phase 3 TROPION-Breast01 trial (NCT05104866) supported this regulatory decision. In the trial, the median progression-free survival (PFS) was 6.9 months (95% CI, 5.7-7.4) in the Dato-DXd arm and 4.9 months (95% CI, 4.2-5.5) in the chemotherapy arm (HR, 0.63; 95% CI, 0.52-0.76; two-sided P-value <.0001).
The median overall survival (OS) was 18.6 months (95% CI, 17.3-20.1) in the Dato-DXd arm and 18.3 months (95% CI, 17.3-20.5) in the chemotherapy arm (HR, 1.01; 95% CI, 0.83-1.22; two-sided P-value was not statistically significant). The confirmed overall response rate (ORR) was 36% (95% CI, 31-42) and 23% (95% CI, 19-28) and median duration of response (DOR) was 6.7 months (95% CI, 5.6-9.8) and 5.7 months (95% CI, 4.9-6.8) in the Dato-DXd and chemotherapy arms, respectively.
“Antibody-drug conjugates are slowly replacing chemotherapy, and we are seeing more and more antibody-drug conjugates come in for metastatic breast cancer in HR-positive setting, but also triple negative breast cancer [TNBC]. Specifically for Dato-DXd, it is being evaluated as a first-line therapy for patients with metastatic TNBC. It is also being evaluated for localized TNBC. So, a lot of exciting trials that are ongoing that will further change the therapeutic landscape in this setting,” adds Bardia.
