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Gilead Highlights P-III (ASCENT-03) Trial Data of Trodelvy for Triple-Negative Breast Cancer (TNBC) at ESMO 2025

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  • The P-III (ASCENT-03) trial (n= 558) assessed Trodelvy (sacituzumab govitecan-hziy; 10mg/kg, IV, Day 1 & 8 of 21-day cycle) vs CT in 1L pts with locally advanced, inoperable, or metastatic TNBC without PD-L1 expression or PD-L1+ pts who were previously treated with a PD-L1 inhibitor
  • Trial met its 1EP of improved PFS by 38% (mPFS: 9.7 vs 6.9mos.) in pts ineligible for PD-1/PD-L1 inhibitors, with consistent PFS benefit seen across all subgroups, incl. pts with poorer prognosis & regardless of CT chosen
  • Trial also showed an ORR of 48% vs 46%, with mDoR of 12.2 vs 7.2mos.; OS (2EP) data remains immature & will be assessed later. Results were published in The NEJM

Ref: Gilead| Image: Gilead| Press Release

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