ASCENT-04

NCT05382286 📎

Regimen

Experimental
Sacituzumab govitecan-hziy 10 mg/kg D1,8 Q3W + pembrolizumab 200 mg Q3W.
Control
Pembrolizumab 200 mg Q3W + investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine/carboplatin) -- KEYNOTE-355 regimen.

Population

Previously untreated locally advanced unresectable or metastatic triple-negative breast cancer with PD-L1 CPS>=10.

Key finding

ASCENT-04 showed sacituzumab govitecan + pembrolizumab improves PFS over pembrolizumab + chemotherapy in PD-L1 CPS>=10 1L metastatic TNBC. Basis for NCCN v2.2026 upgrade of saci + pembro to category 1 first-line.

Source: PMID 41564397

Timeline

  • Publication: 2026 Jan 22

Guideline citations

  • NCCN BREAST