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Datopotamab deruxtecan in patients with untreated, advanced triple-negative breast cancer (TROPION-Breast02): a
1Department of Medical Oncology, National Cancer Center Singapore, Singapore and Duke-NUS Medical School, Singapore, Singapore.
Background:
Prognosis is poor, and treatment options are limited for patients with previously untreated, advanced triple-negative breast cancer (TNBC), especially for those who are not candidates for immunotherapy.
Patients And Methods:
In the randomised, open-label, phase III TROPION-Breast02 trial, patients with previously untreated, locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option were randomly assigned 1:1 to datopotamab deruxtecan (Dato-DXd; 6 mg/kg intravenously every 3 weeks) or investigator's choice of chemotherapy. Randomisation was stratified by geographic location, disease-free interval, and programmed cell death ligand-1 status. Dual primary endpoints were progression-free survival (PFS; blinded independent central review per RECIST version 1.1) and overall survival (OS). Efficacy analyses were performed in the intention-to-treat population. Safety analyses included all patients who received ≥1 dose of study treatment.
Results:
Between 16 May 2022 and 11 June 2024, 644 patients were randomly assigned to receive Dato-DXd (n = 323) or chemotherapy (n = 321). Median PFS was 10.8 months [95% confidence interval (CI) 8.6-13.0] with Dato-DXd and 5.6 months (95% CI 5.0-7.0) with chemotherapy [hazard ratio 0.57 (99% CI 0.44-0.73); P < 0.0001]. Median OS was 23.7 months (95% CI 19.8-25.6) and 18.7 months (95% CI 16.0-21.8) with Dato-DXd and chemotherapy, respectively [hazard ratio 0.79 (95.01% CI 0.64-0.98); P = 0.029]. Treatment-related adverse events (TRAEs) of grade ≥3 were reported in 105 (33%) and 89 (29%) patients who received Dato-DXd and chemotherapy, respectively, and TRAEs led to treatment discontinuation in 14 (4%) and 23 (7%) patients. There were no treatment-related deaths in either arm.
Conclusions:
Dato-DXd demonstrated significantly improved PFS and OS versus chemotherapy in patients with previously untreated, locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. Safety was consistent with the known profile for Dato-DXd.
Insights
Datopotamab deruxtecan (Dato-DXd) significantly improved progression-free survival and overall survival in patients with advanced triple-negative breast cancer (TNBC) when immunotherapy was not an option. This new treatment offers a promising alternative to chemotherapy for eligible TNBC patients.
Area of Science:
- Oncology
- Clinical Trials
- Pharmacology
Background:
- Advanced triple-negative breast cancer (TNBC) presents a poor prognosis with limited treatment alternatives.
- Patients unsuitable for immunotherapy require novel therapeutic strategies.
- Existing chemotherapy options offer suboptimal outcomes for advanced TNBC.
Purpose of the Study:
- To evaluate the efficacy and safety of datopotamab deruxtecan (Dato-DXd) compared to chemotherapy.
- To assess Dato-DXd as a first-line treatment for patients with advanced TNBC ineligible for immunotherapy.
- To determine the impact of Dato-DXd on progression-free survival (PFS) and overall survival (OS).
Main Methods:
- A randomized, open-label, phase III trial (TROPION-Breast02) involving 644 patients.
- Patients received either Dato-DXd (6 mg/kg IV every 3 weeks) or investigator's choice of chemotherapy.
- Primary endpoints included PFS and OS, analyzed in the intention-to-treat population.
Main Results:
- Median PFS was 10.8 months with Dato-DXd versus 5.6 months with chemotherapy (hazard ratio 0.57).
- Median OS was 23.7 months with Dato-DXd compared to 18.7 months with chemotherapy (hazard ratio 0.79).
- Grade ≥3 treatment-related adverse events occurred in 33% of patients on Dato-DXd and 29% on chemotherapy.
Conclusions:
- Datopotamab deruxtecan (Dato-DXd) demonstrated statistically significant improvements in PFS and OS.
- Dato-DXd represents a superior treatment option over chemotherapy for previously untreated advanced TNBC patients not eligible for immunotherapy.
- The safety profile of Dato-DXd was consistent with its known characteristics.
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