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Poster session 10

1607P - Association of the lipid biomarker, PCPro, and clinical outcomes in the ENZAMET trial (ANZUP 1304)

Date

14 Sep 2024

Session

Poster session 10

Topics

Translational Research;  Endocrine Therapy

Tumour Site

Prostate Cancer

Presenters

Lisa Horvath

Citation

Annals of Oncology (2024) 35 (suppl_2): S962-S1003. 10.1016/annonc/annonc1607

Authors

L.G. Horvath1, H. Lin2, I.D. Davis3, A. Martin4, T. Scheinberg1, P. Meikle5, A. Joshua6, M. Mcjannett7, V. Subhash7, S. Yip8, S. North9, R.S. McDermott10, K.N. Chi11, M.R. Stockler12, C. Sweeney13

Author affiliations

  • 1 Medical Oncology, Chris O'Brien Lifehouse, 2050 - Camperdown/AU
  • 2 Cancer, Garvan Institute of Medical Research, 2010 - Darlinghurst/AU
  • 3 Eastern Health Clinical School, Eastern Health Clinical School - Monash University, 3128 - Box Hill/AU
  • 4 Centre For Clinical Research, University of Queensland, 4006 - Brisbane/AU
  • 5 Obesity And Lipids Program, Baker Heart and Diabetes Institute, 3004 - Melbourne/AU
  • 6 Medical Oncology, The Kinghorn Cancer Centre, 2010 - Sydney/AU
  • 7 Clinical Trials Research, ANZUP Cancer Clinical Trials, 2000 - Sydney/AU
  • 8 Clinical Trials Research, NHMRC Clinical Trials Centre, 1450 - Camperdown/AU
  • 9 Medical Oncology Department, University of Alberta Cross Cancer Institute, T6G 1Z2 - Edmonton/CA
  • 10 Medical Oncology, St Vincent's University Hospital and Cancer Trials Ireland, D24 NR0A - Dublin/IE
  • 11 Medical Oncology Department, BC Cancer Agency - Vancouver, V5Z 4E6 - Vancouver/CA
  • 12 Nhmrc Clinical Trials Centre, NHMRC Clinical Trials Centre, 1450 - Camperdown/AU
  • 13 South Australian Immunogenomics Cancer Institute, The University of Adelaide, 5005 - Adelaide/AU

Resources

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Abstract 1607P

Background

Enzalutamide (ENZ) significantly improves overall survival (OS) of patients (pts) with metastatic hormone sensitive prostate cancer (mHSPC). However, a subgroup of pts progress early and the cancer causes death within 2 years of diagnosis. Pts treated with ENZ, who tested positive for PCPro, a validated circulating lipid panel, have shorter progression-free survival (PFS) and OS in castrate-resistant PC. We assessed the relationship between PCPro and clinical outcome in mHSPC treated with ENZ through a post-hoc analysis of ENZAMET (NCT02446405).

Methods

In ENZAMET, 1125 pts were randomised to testosterone suppression (TS) plus either a non-steroidal anti-androgen (NSAA) or ENZ. Stratification factors included volume of disease and planned use of concurrent docetaxel (DTX). Circulating lipids in baseline plasma from 866 pts were profiled by liquid chromatography-mass spectrometry and used to ascertain PCPro status. Kaplan-Meier/Cox regression modeling assessed the association with survival endpoints.

Results

The 866 pts subset was representative of the whole cohort and 116/866 (13.3%) of the pts were PCPro positive. PCPro-positive pts had shorter clinical PFS (HR 1.65, 95% CI 1.32-2.07, p<0.0001) and OS (HR 1.81, 95%CI 1.40-2.33, p<0.0001) than PCPro-negative pts. PCPro is an independent prognostic factor when modeled with clinical factors (Table). The effect of ENZ versus NSAA on OS differed by PCPro status (interaction p=0.024) – PCPro is associated with lack of OS benefit with ENZ (HR 1.10, 95% CI 0.69-1.74, p=0.7). PCPro-negative pts had the expected benefit from ENZ (HR 0.61, 95% CI 0.49-0.76, p<0.0001).

Conclusions

PCPro is an independent prognostic biomarker for shorter OS in pts with mHSPC treated with TS + ENZ or NSAA. PCPro is predictive for lack of enzalutamide OS benefit in mHSPC compared to NSAA. These data provide a rationale for assessing the role of lipid metabolic modulators in pts with PCPro in future clinical trials. Table: 1607P

Multivariable analysis for OS

Variable Hazard ratio 95% CI p-value
PCPro, positive vs negative 1.63 1.26-2.11

Clinical trial identification

NCT02446405.

Editorial acknowledgement

Legal entity responsible for the study

The Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP).

Funding

Astellas.

Disclosure

L.G. Horvath: Financial Interests, Personal, Advisory Board, Honorarium donated back to Chris O'Brien Lifehouse (My hospital): Imagion Biosystems; Financial Interests, Institutional, Invited Speaker: Astellas, Janssen, Amgen; Financial Interests, Institutional, Advisory Board: Astellas, Bayer; Financial Interests, Institutional, Invited Speaker, Bayer paid for travel to Lisbon APEX meeting and accommodation. I gave 3 talks and honorarium paid to be institution: Bayer; Financial Interests, Personal, Member of Board of Directors, No payment: ANZUP (Australia and New Zealand Urogenital and Prostate) Clinical Trials Group; Financial Interests, Personal, Full or part-time Employment, I am a medical oncologist, Director of Research and Chief Clinical Officer of this cancer centre: Chris O'Brien Lifehouse; Financial Interests, Personal, Full or part-time Employment, I am a member of the Garvan Faculty and Laboratory Head: Garvan Institute of Medical Research; Financial Interests, Personal, Stocks/Shares, Stock options: Imagion Biosystems; Financial Interests, Personal, Stocks/Shares: My Emergency Doctor; Financial Interests, Institutional, Other, I am inventor of a patent lead by my institution above: International (PCT) Patent Application No. PCT/AU2023/050849Prognostic Markers (plasma lipid prognostic signature in metastatic prostate cancer).Inventors: Horvath L, Meikle P, Scheinberg S, Lin HM, Sullivan D: Chris O'Brien Lifehouse; Financial Interests, Institutional, Research Grant: Astellas; Financial Interests, Institutional, Local PI, MK7684-001MK3475-991: MSD; Financial Interests, Institutional, Local PI, AMG160 Phase 1AMG509 Phase 1AMG757 Phase 1: Amgen; Financial Interests, Institutional, Local PI, 9785-CL-0335 (ARCHES): Astellas; Financial Interests, Institutional, Local PI, SHR3680-002: Jiangsu Hengrui Medicines; Financial Interests, Institutional, Local PI, TALAPRO2, TALAPRO3: Pfizer; Financial Interests, Institutional, Local PI, CYCLONE-2, CYCLONE-3: Eli Lilly; Financial Interests, Institutional, Steering Committee Member, ENZAMET, ENZARAD, DASL-HiCAP, GUIDE, ANZAdapt: ANZUP; Financial Interests, Institutional, Local PI, GALAHADACISPrevalence: Janssen-Cilag; Financial Interests, Institutional, Local PI, GSK204697: GSK; Financial Interests, Institutional, Local PI, XL184-021: Exelexis; Financial Interests, Institutional, Local PI, BGB-A317BGB-283BGB-A317-290: BeiGene; Financial Interests, Institutional, Local PI, FPT155-001: Five Prime; Financial Interests, Institutional, Local PI, AB928CSP0003: ARCUS; Financial Interests, Institutional, Local PI, ATG-017 and ATG-019: Antagene; Financial Interests, Institutional, Local PI, JANUX007: Janux; Financial Interests, Institutional, Local PI, Petranha: AstraZeneca; Financial Interests, Institutional, Local PI, ENZAMET, ENZA-P, Upfront PSMA, ANZAdapt, GUIDE: ANZUP; Financial Interests, Institutional, Local PI, HP-518-CS-001: Hinova; Financial Interests, Institutional, Local PI, JANX007: Janux Therapeutics; Non-Financial Interests, Leadership Role, Professor of Medical Oncology (Genitourinary cancer): University of Sydney; Non-Financial Interests, Leadership Role, Adjunct Professor: University of New South Wales. H. Lin: Other, Institutional, Other, International (PCT) Patent Application No. PCT/AU2023/050849 Prognostic Markers (plasma lipid prognostic signature in metastatic prostate cancer). Inventors: Horvath L, Meikle P, Scheinberg S, Lin HM, Sullivan D: Garvan Institute. I.D. Davis: Financial Interests, Personal, Full or part-time Employment, Professor of Medicine and Head of Eastern Health Clinical School: Monash University; Financial Interests, Personal, Full or part-time Employment, Professor of Medicine; Head, Eastern Health Clinical School; medical oncologist: Eastern Health; Financial Interests, Institutional, Local PI, Institutional support for clinical research: Movember Foundation, Merck/MSD, Bristol Myers Squibb, Exelixis, Astellas, Pfizer, AstraZeneca, Roche / Genentech, Eisai, Bayer, Janssen, Ipsen, Seagen; Financial Interests, Institutional, Local PI, EPI-7386-CS-010 trial: ESSA Pharma; Non-Financial Interests, Member of Board of Directors, Director and Chair; unremunerated: ANZUP Cancer Trials Group; Non-Financial Interests, Advisory Role, All honoraria and payments are made directly to ANZUP Cancer Trials Group with no pass-through payment: Roche, Eisai, Xennials Therapeutics, Telix Therapeutics, AstraZeneca, Bayer; Non-Financial Interests, Other, Member of Council: Clinical Oncology Society of Australia; Non-Financial Interests, Member: ASCO, Clinical Oncology Society of Australia, Medical Oncology Group of Australia, American Association for Cancer Research, Australian Academy of Health and Medical Sciences. T. Scheinberg: Financial Interests, Personal, Other, Provisional Patent for PCPro: NA. P. Meikle: Other, Institutional, Other, International (PCT) Patent Application No. PCT/AU2023/050849 Prognostic Markers (plasma lipid prognostic signature in metastatic prostate cancer). Inventors: Horvath L, Meikle P, Scheinberg S, Lin HM, Sullivan D: Baker Institute; Financial Interests, Personal and Institutional, Advisory Board: BCAL. A. Joshua: Financial Interests, Personal, Stocks/Shares,

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