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The FDA has approved datopotamab deruxtecan (Dato-DXd) for patients with unresectable or metastatic, HR-positive, HER2-negative breast cancer following prior endocrine-based therapy and chemotherapy. The approval stems from the TROPION-Breast01 trial, which demonstrated superior progression-free survival with Dato-DXd compared to standard chemotherapy options. This advancement provides a new treatment option for patients who have progressed on or become unsuitable for endocrine therapy.
Key Points:
- The TROPION-Breast01 trial enrolled 723 patients randomized to receive either Dato-DXd (n=365) or investigator’s choice of chemotherapy (n=367), including eribulin, capecitabine, vinorelbine, or gemcitabine. The trial design required patients to have experienced disease progression and be unsuitable for further endocrine therapy.
- Dato-DXd demonstrated significantly improved median progression-free survival at 6.9 months compared to 4.6 months with chemotherapy (HR, 0.63; P<.0001). Overall survival showed no significant difference between arms (18.6 vs 18.3 months).
- The objective response rate favored Dato-DXd at 36% versus 23% for chemotherapy, while the duration of response was identical at 5.7 months for both arms.
- Common adverse events (≥20%) included stomatitis, nausea, fatigue, and various laboratory abnormalities affecting blood counts, liver function, and calcium levels. Notably, patients experienced dry eye and keratitis.
- The approved dosing regimen is 6 mg/kg (maximum 540 mg for patients ≥90 kg) administered intravenously every 3 weeks until disease progression or unacceptable toxicity.
Trop-2 is found at high levels in multiple cancers such as prostate, pancreatic, urothelial, lung, and breast cancer. Among different breast cancer subtypes, Trop-2 is most highly expressed in triple negative breast cancer. (Cancers)
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