A Randomized, Open-Label, Phase 2/3 Study of Datopotamab Deruxtecan (Dato-DXd) Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) Who Progressed During or After Enfortumab Vedotin (EV) Plus Pembrolizumab Combination Treatment TROPION-Urothelial03 (TU03)

• Unresectable locally advanced or metastatic urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra
• No urachal, small cell, or adenocarcinoma are allowed
• Squamous differentiation or mixed cell types are eligible if histology is predominantly transitional cell
• Must have had progression of disease after the combination of enfortamab vedotin and pembrolizumab. Can have stopped EV+pembro due to toxicity as long as has had disease progression since then.
• No metastatic prostate cancer, but early stage prostate cancer is allowed if there is no rising PSA and is not currently getting ADT
• Must have tumor tissue sample (can be archival)
• Must be eligible to receive platinum containing chemotherapy
• If patient received gemcitabine, carboplatin, or cisplatin for early UC, at least 1 year must have passed since the last dose
• No prior TROP2 directed ADC therapy
• No uncontrolled or significant cardiac disease
• No history of pneumonitis or clinically severe pulmonary disease

• Primary
  • PFS
  • OS
• Secondary
  • DoR
  • Investigator PFS
  • ORR