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ASCENT-04

ASCENT-04/KEYNOTE-D19: sacituzumab govitecan plus pembrolizumab versus chemotherapy plus pembrolizumab in previously untreated PD-L1-positive advanced triple-negative breast cancer

Phase 3N = 443NCT05382286

Population
Previously untreated PD-L1-positive, locally advanced unresectable or metastatic triple-negative breast cancer (CPS 10 or more by the 22C3 assay per the FDA notice)
Design
International, open-label phase 3 trial, randomised 1:1 to sacituzumab govitecan plus pembrolizumab or chemotherapy plus pembrolizumab. Primary endpoint PFS by blinded independent central review.
Primary endpoint
PFS
Arms
  • Sacituzumab govitecan plus pembrolizumab (experimental, n = 221): Sacituzumab govitecan plus pembrolizumab
  • Chemotherapy plus pembrolizumab (control, n = 222): Chemotherapy plus pembrolizumab
People
Tolaney SM, senior author Schmid P, ASCENT-04/KEYNOTE-D19 Clinical Trial Investigators
PFSHR 0.65 (95% CI 0.51–0.84)Δ median PFS+3.4 monthsΔ ORR+7 pointsΔ median DOR+7.3 months
Show the numbers
Results reported for ASCENT-04
EndpointAnalysisSacituzumab govitecan plus pembrolizumabChemotherapy plus pembrolizumabEffect
PFSAll randomised patientsBlinded independent central reviewprimaryTolaney 2026median 11.2 months (9.3–16.7)median 7.8 months (7.3–9.3)HR 0.65 (95% CI 0.51–0.84)P<0.001Two-sided P. Data for overall survival were immature (per the abstract). Grade 3 or higher adverse events 71% vs 70%; discontinuation due to adverse events 12% vs 31%.
ORRAll randomised patientsprimaryTolaney 202660% (53–66%)53% (46–60%)Objective response (complete or partial) by blinded independent central review.
DORAll randomised patientsprimaryTolaney 2026median 16.5 months (12.7–19.5)median 9.2 months (7.6–11.3)Median duration of response among responders.
Results reported for ASCENT-04
EndpointAnalysisSacituzumab govitecan plus pembrolizumabChemotherapy plus pembrolizumabEffect
PFSAll randomised patientsBlinded independent central reviewprimaryTolaney 2026median 11.2 months (9.3–16.7)median 7.8 months (7.3–9.3)HR 0.65 (95% CI 0.51–0.84)P<0.001Two-sided P. Data for overall survival were immature (per the abstract). Grade 3 or higher adverse events 71% vs 70%; discontinuation due to adverse events 12% vs 31%.
ORRAll randomised patientsprimaryTolaney 202660% (53–66%)53% (46–60%)Objective response (complete or partial) by blinded independent central review.
DORAll randomised patientsprimaryTolaney 2026median 16.5 months (12.7–19.5)median 9.2 months (7.6–11.3)Median duration of response among responders.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.650.51–0.84
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Sacituzumab govitecan plus pembrolizumab (experimental)
  • Chemotherapy plus pembrolizumab (control)

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

Data table (modelled values)
MonthsSacituzumab govitecan plus pembrolizumabChemotherapy plus pembrolizumab
0100.0%100.0%
764.8%53.7%
1442.0%28.8%
2127.3%15.5%
2817.7%8.3%
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%010203040Months (modelled)
  • Sacituzumab govitecan plus pembrolizumab (experimental)
  • Chemotherapy plus pembrolizumab (control)

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

Data table (modelled values)
MonthsSacituzumab govitecan plus pembrolizumabChemotherapy plus pembrolizumab
0100.0%100.0%
1065.7%47.1%
2141.4%20.6%
3127.2%9.7%
4117.9%4.6%
Primary publication: Tolaney SM, de Azambuja E, Kalinsky K, Loi S, Kim SB, Yam C, et al. Sacituzumab Govitecan plus Pembrolizumab for Advanced Triple-Negative Breast Cancer. N Engl J Med. 2026;394(4):354-366. PubMedDOI

Appears in

Sources

  1. Tolaney SM, de Azambuja E, Kalinsky K, Loi S, Kim SB, Yam C, et al. Sacituzumab Govitecan plus Pembrolizumab for Advanced Triple-Negative Breast Cancer. N Engl J Med. 2026;394(4):354-366.

    PubMedDOI