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ASCENT-03

Sacituzumab govitecan versus chemotherapy in previously untreated advanced triple-negative breast cancer in patients who are not candidates for PD-1 or PD-L1 inhibitors

Phase 3N = 558NCT05382299

Population
Previously untreated locally advanced unresectable or metastatic TNBC, not candidates for PD-1 or PD-L1 inhibitors owing to previous use or coexisting conditions; PD-L1 CPS below 10, or CPS 10 or higher
Design
International, open-label phase 3 trial, randomised 1:1 to sacituzumab govitecan or chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin). Primary endpoint PFS by blinded independent central review.
Primary endpoint
PFS
Arms
  • Sacituzumab govitecan (experimental): Sacituzumab govitecan
  • Chemotherapy (control): Paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin
People
Cortés J, senior author Tolaney SM, ASCENT-03 Clinical Trial Investigators
PFSHR 0.62 (95% CI 0.50–0.77)Δ median PFS+2.8 monthsΔ ORR+2 pointsΔ median DOR+5 months
Show the numbers
Results reported for ASCENT-03
EndpointAnalysisSacituzumab govitecanChemotherapyEffect
PFSAll randomised patientsBlinded independent central reviewprimaryCortés 2025median 9.7 months (8.1–11.1)median 6.9 months (5.6–8.2)HR 0.62 (95% CI 0.50–0.77)P<0.001Stratified hazard ratio. Overall survival was a secondary endpoint; no OS values are given in the abstract. Grade 3 or higher adverse events 66% vs 62%.
ORRAll randomised patientsprimaryCortés 202548% (42–54%)46% (40–52%)Confirmed objective response.
DORAll randomised patientsprimaryCortés 2025median 12.2 months (9.7–13.8)median 7.2 months (5.7–8.4)Median response duration.
Results reported for ASCENT-03
EndpointAnalysisSacituzumab govitecanChemotherapyEffect
PFSAll randomised patientsBlinded independent central reviewprimaryCortés 2025median 9.7 months (8.1–11.1)median 6.9 months (5.6–8.2)HR 0.62 (95% CI 0.50–0.77)P<0.001Stratified hazard ratio. Overall survival was a secondary endpoint; no OS values are given in the abstract. Grade 3 or higher adverse events 66% vs 62%.
ORRAll randomised patientsprimaryCortés 202548% (42–54%)46% (40–52%)Confirmed objective response.
DORAll randomised patientsprimaryCortés 2025median 12.2 months (9.7–13.8)median 7.2 months (5.7–8.4)Median response duration.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.620.5–0.77
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Sacituzumab govitecan (experimental)
  • Chemotherapy (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsSacituzumab govitecanChemotherapy
0100.0%100.0%
665.1%54.7%
1242.4%30.0%
1827.6%16.4%
2418.0%9.0%
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%051015202530Months (modelled)
  • Sacituzumab govitecan (experimental)
  • Chemotherapy (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsSacituzumab govitecanChemotherapy
0100.0%100.0%
863.5%46.3%
1542.6%23.6%
2327.1%10.9%
3117.2%5.1%
Primary publication: Cortés J, Punie K, Barrios C, Hurvitz SA, Schneeweiss A, Sohn J, et al. Sacituzumab Govitecan in Untreated, Advanced Triple-Negative Breast Cancer. N Engl J Med. 2025;393(19):1912-1925. PubMedDOI

Appears in

Sources

  1. Cortés J, Punie K, Barrios C, Hurvitz SA, Schneeweiss A, Sohn J, et al. Sacituzumab Govitecan in Untreated, Advanced Triple-Negative Breast Cancer. N Engl J Med. 2025;393(19):1912-1925.

    PubMedDOI