ESMO 2025 Datopotamab deruxtecan effective in triple-negative breast cancer

MedNet.nl: In patients with metastatic or locally recurrent, inoperable triple-negative breast cancer (TNBC) who are not eligible for immunotherapy, datopotamab deruxtecan (Dato-DXd) leads to better survival than standard chemotherapy. According to the researchers of the phase 3 TROPION-Breast02 study, the treatment should become the new standard treatment in the first-line setting.

Approximately 70% of patients with advanced or metastatic TNBC are not eligible for first-line immunotherapy. For this group, the standard treatment consists of chemotherapy, but this treatment is not very effective in this patient group. Partly as a result of this, approximately half of the patients ultimately do not receive second-line treatment. In an attempt to improve the outcomes of first-line therapy, the researchers of the phase 3 TROPION-Breast02 study compared Dato-DXd with standard chemotherapy. Participants in the study were women with metastatic or locally recurrent, inoperable TNBC, who were randomized between Dato-DXd (n=323) and chemotherapy of the clinician's choice (paclitaxel, nab-paclitaxel, capecitabine, eribulin, carboplatin; n=321). The study had two primary endpoints: progression-free survival (PFS) and overall survival (OS).

After a median follow-up of 27.5 months, median PFS had nearly doubled in the Dato-DXd arm: 10.8 months versus 5.6 months (HR=0.57). After 12 and 18 months, 45.6% versus 25.6% and 32.7% versus 16.8% of patients were progression-free, respectively. Median OS was also better in the Dato-DXd arm: 23.7 months versus 18.7 months (HR=0.79), with survival at 12 and 18 months of 75.2% versus 67.8% and 61.2% versus 51.3%. The response rate was also significantly higher (62.5 vs 29.3%), with complete responses in 9.0% versus 2.5%.

The incidence of grade ≥3 treatment-related adverse events was comparable (33 vs 29%), but fewer patients in the Dato-DXd arm discontinued treatment due to adverse events (4 vs 7%).

Dent R, et al. First-line (1L) datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (mTNBC) for whom immunotherapy was not an option: primary results from the randomised, phase 3 TROPION-Breast02 trial. ESMO 2025, abstract LBA21.

This article was originally published in Dutch on MedNet.nl