The U.S. Food and Drug Administration (FDA) approved datopotamab deruxtecan-dlnk (Datroway), an antibody-drug conjugate targeting trophoblast cell surface antigen 2 (TROP2), for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval was granted on May 22, 2026.
TROPION-Breast02
Efficacy was evaluated in TROPION-Breast02 (ClinicalTrials.gov identifier NCT05374512), a multicenter, open-label, randomized trial of 644 patients with unresectable or metastatic TNBC who had not received prior chemotherapy or other systemic anticancer therapy for unresectable or metastatic breast cancer and who were not candidates for PD-1/PD-L1 inhibitor therapy.
Random assignment was stratified by geographic region (United States, Canada, and Europe, or rest of world), PD-L1 status (positive or negative), and disease-free interval history (de novo or ≤ 12 months or > 12 months). Patients were randomly assigned 1:1 to receive either datopotamab deruxtecan-dlnk (n = 323) or investigator’s choice of chemotherapy (n = 321)—either paclitaxel (28%), nab-paclitaxel (54%), capecitabine (2.2%), eribulin (11%), or carboplatin (4.7%).
The major efficacy outcome measures were progression-free survival as assessed by blinded independent central review based on Response Evaluation Criteria in Solid Tumors version 1.1 and overall survival; additional efficacy outcome measures included confirmed overall response rate by blinded independent central review.
Median progression-free survival was 10.8 months (95% confidence interval [CI] = 8.6–13.0 months) in the datopotamab deruxtecan-dlnk arm and 5.6 months (95% CI = 5.0–7.0 months) in the chemotherapy arm (hazard ratio [HR] = 0.57, 95% CI = 0.47–0.69, P < .0001). Median overall survival was 23.7 months (95% CI = 19.8–25.6 months) and 18.7 months (95% CI = 16.0–21.8 months) in the respective arms (HR = 0.79, 95% CI = 0.64–0.98, P = .0290). Confirmed overall response rate was 64% (95% CI = 58%–69%) and 30% (95% CI = 25%–36%) in the respective arms.
Visit FDA.org for additional information about dosage and safety. This application was granted Priority Review.
Reference
1. Cescon DW, et al: First-line datopotamab deruxtecan vs chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer for whom immunotherapy was not an option. Abstract 1002. 2026 ASCO Annual Meeting. Presented May 31, 2026.
