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PD-L1 immunohistochemistry assay comparison in atezolizumab plus nab-paclitaxel-treated advanced triple-negative breast cancer

In the phase III IMpassion130 study, atezolizumab plus nab-paclitaxel (A+nP) showed clinical benefit in advanced or metastatic triple-negative breast cancer patients who were programmed death-ligand 1 (PD-L1)+ (tumor-infiltrating immune cells [IC] ≥1%) using the SP142 immunohistochemistry assay. Her...

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Main Authors: Rugo, Hope S. (Author) , Loi, Sherene (Author) , Adams, Sylvia (Author) , Schmid, Peter (Author) , Schneeweiss, Andreas (Author) , Barrios, Carlos H (Author) , Iwata, Hiroji (Author) , Diéras, Véronique (Author) , Winer, Eric P (Author) , Kockx, Mark M (Author) , Peeters, Dieter (Author) , Chui, Stephen Y (Author) , Lin, Jennifer C (Author) , Nguyen-Duc, Anh (Author) , Viale, Giuseppe (Author) , Molinero, Luciana (Author) , Emens, Leisha A (Author)
Format: Article (Journal)
Language:English
Published: June 7, 2021
In: Journal of the National Cancer Institute
Year: 2021, Volume: 113, Issue: 12, Pages: 1733-1743
ISSN:1460-2105
DOI:10.1093/jnci/djab108
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1093/jnci/djab108
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Author Notes:Hope S. Rugo, MD, Sherene Loi, MD, PhD, Sylvia Adams, MD, Peter Schmid, MD, PhD, Andreas Schneeweiss, MD, Carlos H. Barrios, MD, Hiroji Iwata, MD, PhD, Véronique Diéras, MD, Eric P. Winer, MD, Mark M. Kockx, MD, PhD, Dieter Peeters, MD, PhD, Stephen Y. Chui, MD, Jennifer C. Lin, PhD, Anh Nguyen-Duc, PhD, Giuseppe Viale, MD, Luciana Molinero, PhD, Leisha A. Emens, MD, PhD
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Summary:In the phase III IMpassion130 study, atezolizumab plus nab-paclitaxel (A+nP) showed clinical benefit in advanced or metastatic triple-negative breast cancer patients who were programmed death-ligand 1 (PD-L1)+ (tumor-infiltrating immune cells [IC] ≥1%) using the SP142 immunohistochemistry assay. Here we evaluate 2 other PD-L1 assays for analytical concordance with SP142 and patient-associated clinical outcomes.Samples from 614 patients (68.1% of intention-to-treat population) were centrally evaluated by immunohistochemistry for PD-L1 status on IC (VENTANA SP142, SP263, Dako 22C3) or as a combined positive score (CPS; 22C3).Using SP142, SP263, and 22C3 assays, PD-L1 IC ≥1% prevalence was 46.4% (95% confidence interval [CI] = 42.5% to 50.4%), 74.9% (95% CI = 71.5% to 78.3%), and 73.1% (95% CI = 69.6% to 76.6%), respectively; 80.9% were 22C3 CPS ≥1. At IC ≥1% (+), the analytical concordance between SP142 and SP263 and 22C3 was 69.2% and 68.7%, respectively. Almost all SP142+ cases were captured by other assays (double positive), but several SP263+ (29.6%) or 22C3+ (29.0%) cases were SP142- (single positive). A+nP clinical activity vs placebo+nP in SP263+ and 22C3+ patients (progression-free survival [PFS] hazard ratios [HRs] = 0.64 to 0.68; overall survival [OS] HRs = 0.75 to 0.79) was driven by double-positive cases (PFS HRs = 0.60 to 0.61; OS HRs = 0.71 to 0.75) rather than single-positive cases (PFS HRs = 0.68 to 0.81; OS HRs = 0.87 to 0.95). Concordance for harmonized cutoffs for SP263 (IC ≥4%) and 22C3 (CPS ≥10) to SP142 (IC ≥1%) was subpar (approximately 75%).22C3 and SP263 assays identified more patients as PD-L1+ (IC ≥1%) than SP142. No inter-assay analytical equivalency was observed. Consistent improved A+nP efficacy was captured by the SP142 PD-L1 IC ≥1% subgroup nested within 22C3 and SP263 PD-L1+ (IC ≥1%) populations.
Item Description:Gesehen am 05.10.2022
Physical Description:Online Resource
ISSN:1460-2105
DOI:10.1093/jnci/djab108

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