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BIOMARKER:

AR-V7 negative

10ms
Blood based biomarkers identify metastatic castration-resistant prostate cancer (mCRPC) with the greatest benefit from continuing enzalutamide (ENZ) beyond progression in combination with docetaxel (Doc): A pre-specified biomarker study of the phase IIIb PRESIDE trial (ESMO 2023)
Conclusions The benefit of continuing ENZ beyond progression with Doc vs Doc alone is greatest in patient with no evidence of plasma AR gain or AR-V7+ CTC. Plasma tumor DNA detection after 3 weeks Doc +/- ENZ identifies patients with shorter PFS.
P3 data • Combination therapy • Metastases
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AR (Androgen receptor)
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AR-V7 positive • AR wild-type • AR-V7 negative
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docetaxel • Xtandi (enzalutamide capsule)
2years
The expression of androgen receptor splice variant 7 at radical prostatectomy predicts the risk of progression in untreated non-metastatic prostate cancer patients (AUA 2022)
At this early stage, independently to ADT administration, AR-V7 positivity is associated to risk classification and it can predict biochemical and radiological progression after surgery. Validation of our findings in a larger cohort will be relevant for further studies to define a subset of PC cases submitted to RP in which intensification of adjuvant treatments could be indicated.
Clinical
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AR (Androgen receptor)
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AR expression • AR splice variant 7 • AR-V7 expression • AR-V7 positive • AR-V7 negative • AR splice variant 7 expression
2years
Circulating tumor cell gene expression and plasma AR gene copy number as biomarkers for castration-resistant prostate cancer patients treated with cabazitaxel. (PubMed, BMC Med)
Baseline CTC biomarkers may be prognosticators for cabazitaxel-treated mCRPC patients. Cabazitaxel at lower (20 mg/sqm) dose was associated with poorer outcomes in AR-V7 positive patients compared to AR-V7 negative patients in a post hoc subgroup analysis.
Journal • Circulating Tumor Cells
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AR (Androgen receptor) • AKR1C3 (Aldo-Keto Reductase Family 1 Member C3) • EPCAM (Epithelial cell adhesion molecule) • ALDH1A1 (Aldehyde Dehydrogenase 1 Family Member A1) • HPRT1 (Hypoxanthine Phosphoribosyltransferase 1) • MDK (Midkine)
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AR expression • AR-V7 expression • AR-V7 positive • KIT expression • AR-V7 negative • AR splice variant 7 expression • EPCAM expression
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docetaxel • cabazitaxel
over2years
Enrollment change • Checkpoint inhibition
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AR (Androgen receptor)
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AR expression • AR splice variant 7 • AR-V7 expression • AR-V7 positive • AR-V7 negative • AR splice variant 7 expression
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Opdivo (nivolumab) • Yervoy (ipilimumab) • Xtandi (enzalutamide capsule)
over2years
Impact of AR-V7 and other androgen receptor splice variant expression on outcomes of post-prostatectomy salvage therapy. (ASCO-GU 2022)
Using ultra-deep targeted RNA-Seq, we provide among the first comprehensive descriptions of the ARV landscape in primary prostate cancer. Moreover, we show that detectable AR-V7 in prostatectomy specimens was associated with inferior outcomes following salvage RT+ADT, suggesting for the first time that AR-V7 may modulate outcomes for localized as well as metastatic disease. Ongoing work includes comparison with Decipher score and validation in independent cohorts.
AR (Androgen receptor)
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AR expression • AR splice variant 7 • AR-V7 positive • AR-V7 negative
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Decipher Prostate Cancer Test
over2years
Impact of AR-V7 and Other Androgen Receptor Splice Variant Expression on Outcomes of Post-Prostatectomy Salvage Therapy. (PubMed, Int J Radiat Oncol Biol Phys)
Using a custom ultra-deep targeted RNA-Seq approach, we provide among the first comprehensive descriptions of the AR splice variant landscape in primary prostate cancer. Moreover, we show that detectable AR-V7 expression in prostatectomy specimens was associated with inferior outcomes following subsequent salvage RT+ADT, suggesting for the first time that AR-V7 may modulate outcomes for localized as well as metastatic disease.
Journal
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AR (Androgen receptor)
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AR expression • AR splice variant 7 • AR-V7 expression • AR-V7 positive • AR-V7 negative • AR splice variant 7 expression
over2years
STARVE-PC: Biomarker-Driven Therapy With Nivolumab and Ipilimumab in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Expressing AR-V7 (clinicaltrials.gov)
P2, N=15, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active, not recruiting --> Completed | Trial completion date: Sep 2022 --> Oct 2021 | Trial primary completion date: Sep 2021 --> Dec 2020
Clinical • Trial completion • Trial completion date • Trial primary completion date • Checkpoint inhibition
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AR (Androgen receptor)
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AR splice variant 7 • AR-V7 expression • AR-V7 positive • AR-V7 negative • AR splice variant 7 expression
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Opdivo (nivolumab) • Yervoy (ipilimumab)
over2years
Transcriptional network involving ERG and AR orchestrates Distal-less homeobox-1 mediated prostate cancer progression. (PubMed, Nat Commun)
Notably, inhibiting ERG/AR-mediated DLX1 transcription using BET inhibitor (BETi) or/and anti-androgen drugs reduce its expression and downstream oncogenic effects. Conclusively, this study establishes DLX1 as a direct-target of ERG/AR with an oncogenic role and demonstrates the clinical significance of BETi and anti-androgens for DLX1-positive patients.
Journal
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AR (Androgen receptor) • ERG (ETS Transcription Factor ERG) • FOXA1 (Forkhead Box A1) • DLX1 (Distal-Less Homeobox 1)
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ER positive • AR splice variant 7 • TMPRSS2-ERG fusion • AR-V7 negative
over2years
Androgen receptor splice variant-7 in breast cancer: clinical and pathologic correlations. (PubMed, Mod Pathol)
We conclude that positive AR IHC and apocrine morphology are pathologic features that may indicate testing for AR-V7 is warranted in both primary and metastatic BC in the appropriate clinical context. The study findings further encourage the assessment of AR-V7 as a predictive biomarker for AR antagonist benefit in ongoing clinical BC trials.
Journal • Clinical
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor)
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HER-2 positive • ER positive • HER-2 negative • AR splice variant 7 • AR-V7 positive • AR-V7 negative • ER positive + HER-2 negative
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MSK-IMPACT
3years
Exploring the association between metastatic sites and androgen receptor splice variant 7 (AR-V7) in castration-resistant prostate cancer patients: A meta-analysis of prospective clinical trials. (PubMed, Pathol Res Pract)
The results of this meta-analysis, the first in literature to be specifically focused on this topic so far, suggest that AR-V7 positivity may be associated with any site metastases and bone metastases; conversely, no association has been highlighted between AR-V7 expression and lymph node or visceral metastases. Although this meta-analysis should be interpreted with caution due to some limitations, our findings confirm that AR-V7 status could designate a unique and peculiar subtype of PC. Further studies aimed at improving and standardizing AR-V7 detection in clinical trials on CRPC patients are warranted.
Retrospective data • Journal
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AR (Androgen receptor)
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AR splice variant 7 • AR-V7 expression • AR-V7 positive • AR-V7 negative • AR splice variant 7 expression