Biomarker analysis of the phase III IPATential150 trial of first-line ipatasertib (Ipat) plus abiraterone (Abi) in metastatic castration-resistant prostate cancer (mCRPC)

Zhen Shi; Christopher Sweeney; Sergio Bracarda; Cora N Sternberg; Kim N Chi; David Olmos; Shahneen Kaur Sandhu; Christophe Massard; Nobuaki Matsubara; Marie-Laurence Harle-Yge; Malgorzata Nowicka; Matthew Wongchenko; Johann S De Bono

Conference Proceedings

Biomarker analysis of the phase III IPATential150 trial of first-line ipatasertib (Ipat) plus abiraterone (Abi) in metastatic castration-resistant prostate cancer (mCRPC)

Zhen Shi, Christopher Sweeney, Sergio Bracarda, Cora N Sternberg, Kim N Chi, David Olmos, Shahneen Kaur Sandhu, Christophe Massard, Nobuaki Matsubara, Marie-Laurence Harle-Yge, Malgorzata Nowicka, Matthew Wongchenko, Johann S De Bono

JOURNAL OF CLINICAL ONCOLOGY | AMER SOC CLINICAL ONCOLOGY | Published : 2020

DOI: 10.1200/jco.2020.38.6_suppl.182

Abstract

182 Background: IPATential150 is a randomized trial comparing Ipat + Abi vs placebo + Abi in patients (pts) with 1L mCRPC (NCT03072238). We evaluated the potential associations between PTEN loss, genomic alterations, and country of enrollment (East Asian [EAS] vs non-EAS). Methods: Before randomization, tumor samples (archival > 90%) were centrally tested for PTEN loss by VENTANA PTEN (SP218) immunohistochemistry (IHC) assay (N = 1101). Tumor genetic alterations were profiled by Foundation Medicine FoundationOne CDx (F1CDx) NGS assay (n = 735). Results: Of 1101 pts enrolled, 521 (47%) had PTEN loss by IHC. An overall 76% agreement was observed between PTEN IHC and F1CDx. TMPRSS2 fusion, alt..

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