作者
E Yu, JM Piulats, G Gravis, P Fong, T Todenhöfer, B Laguerre, J Arranz, S Oudard, C Massard, M Stoeckle, LT Nordquist, J Carles, M Huang, Y Li, P Qiu, CH Poehlein, C Schloss, J de Bono
发表日期
2021/9/1
期刊
Annals of Oncology
卷号
32
页码范围
S387
出版商
Elsevier
简介
Background
Mutations in homologous recombination repair genes (HRRm)(eg, BRCAm) are found in mCRPC and associated with response to PARP1 inhibitors including ola. Pembro+ ola showed antitumor activity and acceptable tolerability in molecularly unselected patients (pts) with docetaxel-pretreated mCRPC (phase 1/2 KEYNOTE-365 study, cohort A [NCT02861573]). We evaluated the prevalence of BRCAm and HRRm and their association with antitumor activity.
Methods
Docetaxel-pretreated pts in cohort A of KEYNOTE-365 received pembro 200 mg IV Q3W+ ola 400-mg capsule or 300-mg tablet PO BID. Antitumor activity was evaluated via PSA response rate (≥ 50% reduction from baseline) and ORR per RECIST v1. 1 by central review. ctDNA biomarker studies used Guardant Health (GH) 360 or GH Omni assays; FFPE tissue analyses used FoundationOne® CDx (F1CDx).
Results
BRCAm was detected …
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