OnCo
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ASCENT-04 / KEYNOTE-D19

Showed that pairing an ADC with immunotherapy beats chemotherapy plus immunotherapy in first-line PD-L1-positive TNBC.

PFS 11.2 vs 7.8 months (HR 0.65); ASCO 2026 update showed improved PFS2. Approved 2026. Establishes ADC + checkpoint inhibitor as the new first-line standard for PD-L1+ disease.

Setting
First-line PD-L1+ (CPS ≥10) metastatic TNBC: sacituzumab govitecan + pembrolizumab vs chemotherapy + pembrolizumab
Phase
Phase 3
Sponsor
Gilead / Merck
Registry
Headline result
PFS HR 0.65; PFS2 improved.
Reported
2025
Enrolled
443
Replication
First trial of ADC + PD-1 in TNBC; the design mirrors EV-302 in urothelial cancer. TROPION-Breast05 (Dato-DXd + durvalumab) will be the confirmatory sibling.

Outcomes

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In plain words
What these results mean for people, not percentages
443 people took part
Progression-free survival (BICR)primarysurrogate endpoint
  • Median 11.2 vs 7.8 months with Sacituzumab govitecan + pembrolizumab compared with Chemotherapy + pembrolizumab; about 3.4 months longer for half the group.
  • A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
  • Put another way, the treated group had about 35 percent lower chance of the event at any given time (hazard ratio 0.65, likely range 0.51 to 0.84).
  • This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
Objective response rateresponse endpoint
  • 60 vs 53 out of 100 had their tumour shrink with Sacituzumab govitecan + pembrolizumab compared with Chemotherapy + pembrolizumab; 7 more per 100.
  • Roughly one extra person helped for every 14 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
  • A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
Overall survivalsurvival endpoint
  • Numbers are not recorded here for this endpoint. Sacituzumab govitecan + pembrolizumab: Immature; PFS2 favoured the ADC arm in the ASCO 2026 update.; Chemotherapy + pembrolizumab.
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
  • Immature; PFS2 favoured the ADC arm in the ASCO 2026 update.
Be careful
  • These results apply to the people the trial enrolled: First-line PD-L1+ (CPS ≥10) metastatic TNBC: sacituzumab govitecan + pembrolizumab vs chemotherapy + pembrolizumab. People in a different situation may not see the same effect.
  • The trial selected people by a biomarker (PD-L1); the result should not be assumed for people whose cancer does not have it.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

443 participants enrolled.

Progression-free survival (BICR)primary
HR 0.65 (0.51–0.84) · p = 0.0009
Sacituzumab govitecan + pembrolizumab
11.2 mo
Chemotherapy + pembrolizumab
7.8 mo
Source
Objective response rate
Sacituzumab govitecan + pembrolizumab60 of 100
Chemotherapy + pembrolizumab53 of 100
Overall survival

Immature; PFS2 favoured the ADC arm in the ASCO 2026 update.

EndpointArmnValueHR (95% CI)pSource
Progression-free survival (BICR)primarySacituzumab govitecan + pembrolizumab22111.2 months0.65 (0.51–0.84)0.0009link
Chemotherapy + pembrolizumab2227.8 months
Objective response rateSacituzumab govitecan + pembrolizumab60%
Chemotherapy + pembrolizumab53%
Overall survivalSacituzumab govitecan + pembrolizumabImmature; PFS2 favoured the ADC arm in the ASCO 2026 update.
Chemotherapy + pembrolizumab
Replication
First trial of ADC + PD-1 in TNBC; the design mirrors EV-302 in urothelial cancer. TROPION-Breast05 (Dato-DXd + durvalumab) will be the confirmatory sibling.

Key papers

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Connected

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not linked directly; found by shared links