# ASCENT-03

Source: https://onco.cc/trials/ascent-03/  
OnCo record `ascent-03` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Moved Trodelvy into first-line use for triple-negative patients who cannot receive immunotherapy.

## Summary

FDA reports 558 randomized patients with previously untreated unresectable locally advanced or metastatic TNBC who were not candidates for PD-1/PD-L1 therapy. Sacituzumab govitecan versus chemotherapy improved median PFS, 9.7 versus 6.9 months (HR 0.62, 95% CI 0.50 to 0.77). Overall survival was immature at approval. ClinicalTrials.gov lists 623 actual participants; the difference from the FDA efficacy-study population is retained without inventing a reconciliation. These are advanced-disease outcomes, not postoperative recurrence prevention.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-10-06
- Registry id: NCT05382299
- Phase: 3
- Setting: First-line metastatic TNBC, not candidates for PD-1 inhibitors: sacituzumab govitecan vs chemotherapy
- Sponsor: Gilead
- Enrolled: 558
- Result: FDA reports 558 randomized patients with previously untreated unresectable locally advanced or metastatic TNBC who were not candidates for PD-1/PD-L1 therapy. Sacituzumab govitecan versus chemotherapy improved median PFS, 9.7 versus 6.9 months (HR 0.62, 95% CI 0.50 to 0.77). Overall survival was immature at approval. ClinicalTrials.gov lists 623 actual participants; the difference from the FDA efficacy-study population is retained without inventing a reconciliation. These are advanced-disease outcomes, not postoperative recurrence prevention.
- Outcomes: Progression-free survival (BICR): Sacituzumab govitecan 9.7 months vs Chemotherapy 6.9 months, HR 0.62; Overall survival: Sacituzumab govitecan vs Chemotherapy; Confirmed objective response rate (FDA approval analysis): Sacituzumab govitecan 50% vs Chemotherapy 47%
- Replication: FDA-supporting advanced-disease randomized trial; postoperative benefit is not established.

## Notes

- Primary paper (NEJM 2025): 558 patients not candidates for PD-1 or PD-L1 inhibitors (99.5 percent CPS below 10) randomised 1 to 1; progression-free survival 9.7 versus 6.9 months (hazard ratio 0.62), confirmed response 48 versus 46 percent with a median duration of 12.2 versus 7.2 months; grade 3 or higher adverse events 66 versus 62 percent, discontinuation 4 versus 12 percent; 51 percent of patients had died at the label's data cut with overall survival immature. UK sites (registry, 3): Leeds Teaching Hospitals, Barts Health, University College London Hospitals. NICE appraisal GID-TA11489 awaiting development; EU indication listed in September 2026.

## Sources

- FDA approval and randomized efficacy results: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line
- ASCENT-03 (NEJM 2025): https://doi.org/10.1056/NEJMoa2511734
- Trodelvy label (openFDA): ASCENT-03 study section: https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22TRODELVY%22

## Connected records

- cancers: [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- drugs: [Sacituzumab govitecan](https://onco.cc/drugs/sacituzumab-govitecan/)
- companies: [Gilead Sciences (incl. Kite)](https://onco.cc/companies/gilead/)
- key papers: [ASCENT: sacituzumab govitecan doubles survival in heavily pretreated metastatic triple-negative breast cancer](https://onco.cc/key-papers/paper-ascent-nejm-2021/), [Breast Cancer, Version 4.2026, NCCN Clinical Practice Guidelines In Oncology](https://onco.cc/key-papers/paper-nccn-breast-cancer-v4-2026-jnccn-2026/), [Datopotamab deruxtecan in patients with untreated, advanced triple-negative breast cancer (TROPION-Breast02): a randomised, open-label, international, phase III trial](https://onco.cc/key-papers/paper-tropion-breast02-ann-oncol-2026/), [Sacituzumab Govitecan in Untreated, Advanced Triple-Negative Breast Cancer](https://onco.cc/key-papers/paper-ascent-03-n-engl-j-med-2025/)
- roadmaps: [TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line](https://onco.cc/roadmaps/tnbc-history/), [Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem](https://onco.cc/roadmaps/tnbc-roadmap/), [TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET](https://onco.cc/roadmaps/trop2-adc-roadmap/)
- ideas: [A randomised trial of antibody-drug conjugate sequence in metastatic triple-negative breast cancer](https://onco.cc/ideas/idea-tnbc-adc-sequencing-trial/), [TROP2 PET to choose and sequence TROP2 ADCs](https://onco.cc/ideas/idea-trop2-pet-selection/)
- terms: [Triple-negative breast cancer trials open today (registry snapshot and UK sites)](https://onco.cc/terms/tnbc-trials-open-today/)
- trials: [ASCENT](https://onco.cc/trials/ascent/)

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