Clinical Trial

A phase III, open-label, randomised study of Datopotamab Deruxtecan (Dato-DXd) with or without Durvalumab compared with investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel or gemcitabine + carboplatin) in combination with pembrolizumab in patients with PD-L1 positive locally recurrent inoperable or metastatic Triple-negative Breast Cancer (TROPION-Breast05)

MOA:

Dato-DXd is a TROP2 targeted ADC with a topoisomerase I inhibitor payload

Durvalumab is a PD-L1
inhibitor

Key Eligibility Criteria:

• Locally recurrent inoperable or metastatic TNBC
  • ER, PgRIHC < 1%, HER2 IHC 0, 1+ or 2+ with ISH
  • de novo mTNBC eligible if anthracycline is contraindicated
• PD-L1+ by 22C3 assay, CPS ≥10 by IHC (centrally confirmed)
• No prior chemo or targeted systemic tx in metastatic setting
  • PD must be ≥6 months after completion of tx with curative intent
  • Adjuvant radiation therapy not considered tx with curative intent for DFI
• (Neo)adjuvant anthracycline required unless contraindicated
• Prior (neo)adjuvant tx with PD-(L)1 inhibitor allowed
• Germline BRCAm with no other tx option are eligible
• Metastatic tumor sample must be provided. Archival tissue from early-stage
  TNBC can be considered if collected ≤3 years prior to consent
• Measurable disease per RECIST v1.1. Bone-only disease is not eligible
• Prior tx containing topo I inhibitor-targeted tx (incl ADC) and TROP2-targeted tx
  are excluded
• Neoplastic spinal cord compression or active brain metastases are excluded