# Biomarker analyses in the phase III ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer

Source: https://onco.cc/key-papers/paper-bardia-ascent-trop2-biomarker-ann-oncol-2021/  
OnCo record `paper-bardia-ascent-trop2-biomarker-ann-oncol-2021` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

In ASCENT, sacituzumab govitecan beat chemotherapy in tumours with high and medium TROP2 protein, and worked whether or not the patient carried a germline BRCA mutation; the low-TROP2 group was too small to judge.

## Summary

Prespecified exploratory analysis of ASCENT (metastatic TNBC after two or more chemotherapies) relating tumour Trop-2 expression by validated immunohistochemistry H-score and germline BRCA1/2 status to outcome. Of 468 assessable patients, 290 had Trop-2 data and 292 known BRCA status. Median progression-free survival with sacituzumab versus chemotherapy was 6.9, 5.6 and 2.7 months versus 2.5, 2.2 and 1.6 months for high, medium and low Trop-2; overall survival 14.2, 14.9 and 9.3 versus 6.9, 6.9 and 7.6 months; response 44%, 38% and 22% versus 1%, 11% and 6%. Outcomes favoured sacituzumab with and without germline BRCA1/2 mutation.

## Fields

- Kind: Key paper
- Last checked: 2026-09-24
- Journal: Annals of Oncology
- Year: 2021
- DOI: 10.1016/j.annonc.2021.06.002
- Authors: Bardia A, Tolaney SM, Punie K, et al.
- Findings: High and medium Trop-2: PFS 6.9 and 5.6 versus 2.5 and 2.2 months; response 44% and 38% versus 1% and 11%.; Low Trop-2 group small (PFS 2.7 versus 1.6 months); no conclusion.; Benefit regardless of germline BRCA1/2 status.
- What it means: TROP2 IHC does not gate sacituzumab govitecan: the label requires no test, and the corpus records TROP2 as an expression readout without a threshold.
- Caveats: Trop-2 data in 62% of patients; exploratory.; H-score bands were defined by the sponsor's assay.

## Sources

- Bardia et al., Ann Oncol 2021: Trop-2 and germline BRCA biomarker analyses in ASCENT: https://doi.org/10.1016/j.annonc.2021.06.002
- PubMed: https://pubmed.ncbi.nlm.nih.gov/34116144/

## Connected records

- biomarkers: [TROP2 expression](https://onco.cc/biomarkers/trop2-expression/)
- cancers: [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- targets: [BRCA1 / BRCA2 (HRD)](https://onco.cc/targets/brca/), [TROP2](https://onco.cc/targets/trop2/)
- drugs: [Sacituzumab govitecan](https://onco.cc/drugs/sacituzumab-govitecan/)
- companies: [Gilead Sciences (incl. Kite)](https://onco.cc/companies/gilead/)
- terms: [Germline BRCA mutation (gBRCA)](https://onco.cc/terms/gbrca-mutation/), [Immunohistochemistry (IHC)](https://onco.cc/terms/ihc/)
- trials: [ASCENT](https://onco.cc/trials/ascent/)
- people: [Aditya Bardia](https://onco.cc/people/aditya-bardia/), [Kevin Kalinsky](https://onco.cc/people/kevin-kalinsky/), [Priyanka Sharma](https://onco.cc/people/priyanka-sharma/), [Sara M. Tolaney](https://onco.cc/people/sara-tolaney/)
- journals: [Annals of Oncology](https://onco.cc/journals/annals-of-oncology/)

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