{"entity":{"id":"paper-bardia-ascent-trop2-biomarker-ann-oncol-2021","kind":"paper","name":"Biomarker analyses in the phase III ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer","aka":[],"tldr":"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.","asOf":"2026-09-24","links":[{"label":"Bardia et al., Ann Oncol 2021: Trop-2 and germline BRCA biomarker analyses in ASCENT","url":"https://doi.org/10.1016/j.annonc.2021.06.002"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/34116144/"}],"tags":[],"related":["trop2-expression"],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":[],"targets":["trop2","brca"],"drugs":["sacituzumab-govitecan"],"companies":["gilead"],"institutions":[],"pathways":[],"terms":["ihc","gbrca-mutation"],"trials":["ascent"],"people":["aditya-bardia","sara-tolaney","kevin-kalinsky","priyanka-sharma"],"bottlenecks":[],"keyPapers":[],"journals":["annals-of-oncology"],"dependsOn":[],"notes":[],"journal":"Annals of Oncology","year":2021,"doi":"10.1016/j.annonc.2021.06.002","pmid":"34116144","authors":"Bardia A, Tolaney SM, Punie K, et al.","paperType":"rct","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."],"whatItMeans":"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."],"changedPractice":false,"participants":468},"route":"/key-papers/paper-bardia-ascent-trop2-biomarker-ann-oncol-2021/","neighbours":{"biomarker":[{"id":"trop2-expression","kind":"biomarker","name":"TROP2 expression","route":"/biomarkers/trop2-expression/"}],"cancer":[{"id":"tnbc-metastatic","kind":"cancer","name":"Metastatic triple-negative breast cancer","route":"/cancers/tnbc-metastatic/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"target":[{"id":"brca","kind":"target","name":"BRCA1 / BRCA2 (HRD)","route":"/targets/brca/"},{"id":"trop2","kind":"target","name":"TROP2","route":"/targets/trop2/"}],"drug":[{"id":"sacituzumab-govitecan","kind":"drug","name":"Sacituzumab govitecan","route":"/drugs/sacituzumab-govitecan/"}],"company":[{"id":"gilead","kind":"company","name":"Gilead Sciences (incl. Kite)","route":"/companies/gilead/"}],"term":[{"id":"gbrca-mutation","kind":"term","name":"Germline BRCA mutation (gBRCA)","route":"/terms/gbrca-mutation/"},{"id":"ihc","kind":"term","name":"Immunohistochemistry (IHC)","route":"/terms/ihc/"}],"trial":[{"id":"ascent","kind":"trial","name":"ASCENT","route":"/trials/ascent/"}],"person":[{"id":"aditya-bardia","kind":"person","name":"Aditya Bardia","route":"/people/aditya-bardia/"},{"id":"kevin-kalinsky","kind":"person","name":"Kevin Kalinsky","route":"/people/kevin-kalinsky/"},{"id":"priyanka-sharma","kind":"person","name":"Priyanka Sharma","route":"/people/priyanka-sharma/"},{"id":"sara-tolaney","kind":"person","name":"Sara M. Tolaney","route":"/people/sara-tolaney/"}],"journal":[{"id":"annals-of-oncology","kind":"journal","name":"Annals of Oncology","route":"/journals/annals-of-oncology/"}]}}