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Showed that pairing an ADC with immunotherapy beats chemotherapy plus immunotherapy in first-line PD-L1-positive TNBC.
FDA reports 443 randomized patients with previously untreated advanced TNBC and PD-L1 CPS at least 10. Sacituzumab govitecan plus pembrolizumab versus chemotherapy plus pembrolizumab improved median PFS, 11.2 versus 7.8 months (HR 0.65, 95% CI 0.51 to 0.84). Overall survival was immature at approval. The June 24, 2026 approval concerns advanced disease, not postoperative recurrence prevention.
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 randomised.
95% CI 55 to 68 · 95% CI 48 to 62
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (BICR)primary | Sacituzumab govitecan plus pembrolizumab | - | 11.2 months | 0.65 (0.51 to 0.84) | 0.0009 | link |
| Chemotherapy plus pembrolizumab | - | 7.8 months | ||||
| Overall survival | Sacituzumab govitecan plus pembrolizumab | - | Immature at FDA approval on June 24, 2026. | - | - | link |
| Chemotherapy plus pembrolizumab | - | - | ||||
| Confirmed objective response rate (FDA approval analysis) | Sacituzumab govitecan plus pembrolizumab | - | 61% | - | - | link |
| Chemotherapy plus pembrolizumab | - | 55% |
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
NCCN is the source of the category grades on the triple-negative breast cancer page and the first major guideline to place an antibody-drug conjugate first line for the disease.
This is the paper Europe PMC returns for registry id NCT05382286 with the most citations, so it is the natural first reading for anyone following the ASCENT-04 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
Sacituzumab govitecan is a standard second-line or later treatment for metastatic triple-negative breast cancer, roughly doubling survival compared with the chemotherapies it was tested against. Patients should expect neutropenia and diarrhoea, which are manageable with growth factor support and loperamide. Trials are now testing it earlier, in first-line combinations with pembrolizumab and after surgery for residual disease.
Shares Breast Cancer, Version 4.2026, NCCN Clinical Practice Guidelines In Oncology, TROP2 PET to choose and sequence TROP2 ADCs, ASCENT, TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line.
Shares ADC + checkpoint inhibitor, Trials that include, and report, brain metastases in triple-negative breast cancer, KEYNOTE-355, TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line.
Shares Breast Cancer, Version 4.2026, NCCN Clinical Practice Guidelines In Oncology, TROP2 PET to choose and sequence TROP2 ADCs, TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET.
Shares Trials that include, and report, brain metastases in triple-negative breast cancer, TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line, Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem, Metastatic triple-negative breast cancer.
Shares ASCENT, ASCENT: sacituzumab govitecan doubles survival in heavily pretreated metastatic triple-negative breast cancer, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, ADC roadmap: from Mylotarg to bispecific and dual-payload ADCs.
Shares TROP2 PET to choose and sequence TROP2 ADCs, TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, ADC roadmap: from Mylotarg to bispecific and dual-payload ADCs.
Shares Gilead Sciences (incl. Kite), Sacituzumab govitecan, Metastatic triple-negative breast cancer, Topoisomerase-I inhibitors (and ADC payloads).
Shares KEYNOTE-355, ASCENT, Metastatic triple-negative breast cancer, Merck & Co. (MSD).
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/