Clinical Trial

Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan Maintenance With or Without Bevacizumab vs Standard of Care in Participants With Newly Diagnosed Advanced HRD Negative Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOT-ov85/GOG-3102)

MOA: Sacituzumabtirumotecan (Sac-TMT) is a TROP2 targeting ADC with a TOP1i payload.

Key Eligibility

• Confirmed FIGO Stage III or IV epithelial OC/FT/PPC
  • Allows high-grade serous, endometrioid, carcinosarcoma/mixed
    Müllerian with high-grade serous component, clear cell, low-grade
    serous histologies
• Has undergone debulking surgery (primary [PDS] or interval [IDS])
• Must have completed 4-6 cycles of 1L plt-based chemo
  • For IDS: ≥2 but preferably 3 cycles of 1L plt-based chemo after
    surgery
• ≤12 weeks between last dose of 1L plt-based chemo and randomization
• Has CR, PR, SD, or NED by the investigator to 1L plt-based chemo at
  screening (based on RECIST 1.1 and CA-125 levels and evaluated
  between 3-6 weeks after last dose of plt)
• Not eligible to receive PARPi as 1L maintenance tx
• HRD-negative and known TROP2 status by prospective central testing
• Prior tx with TROP2-targeted ADC or topoisomerase I-containing ADCs
  are excluded