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Poster session 14

1806P - Efficacy of niraparib and abiraterone acetate plus prednisone (NIRA+AAP) in homologous recombination repair gene-altered (HRR+) metastatic castration-resistant prostate cancer (mCRPC) by tissue and/or plasma assays in the MAGNITUDE trial

Date

21 Oct 2023

Session

Poster session 14

Topics

Tumour Site

Prostate Cancer

Presenters

Gerhardt Attard

Citation

Annals of Oncology (2023) 34 (suppl_2): S954-S1000. 10.1016/S0923-7534(23)01946-4

Authors

G. Attard1, S.K. Sandhu2, D. Rathkopf3, E. Castro4, M. Saad5, M.R. Smith6, E.J.J. Small7, D. Olmos4, A.J.P.D.S. Gomes8, G. Roubaud9, B. Zurawski10, E. Efstathiou11, D. Wu12, B. Diorio13, K. Urtishak14, U. Singh15, Y. Xu15, A. Lopez-Gitlitz12, A. del Corral16, K.N.N. Chi17

Author affiliations

  • 1 Research Department Of Oncology, University College London, WC1E 6JD - London/GB
  • 2 Division Of Cancer Medicine, Peter MacCallum Cancer Centre, 3000 - Melbourne/AU
  • 3 Department Of Medicine, Memorial Sloan Kettering Cancer Center, 10065 - New York/US
  • 4 Department Of Medical Oncology, Hospital Universitario 12 de Octubre, 28041 - Madrid/ES
  • 5 Department Of Clinical Oncology, UMMC - University Malaya Medical Centre, 59100 - Kuala Lumpur/MY
  • 6 Department Of Hematology/oncology, Massachusetts General Hospital Cancer Center, Harvard Medical School, 02114 - Boston/US
  • 7 Helen Diller Family Comprehensive Cancer Center, University of California San Francisco Medical Center, 94158 - San Francisco/US
  • 8 Department Of Medical Oncology, Liga Norte Riograndense Contra o Câncer, 59075-740 - Natal/BR
  • 9 Department Of Medical Oncology, Institute Bergonié, 33000 - Bordeaux/FR
  • 10 Department Of Clinical Oncology, Franciszek Łukaszczyk Oncology Centre, 85-796 - Bydgoszcz/PL
  • 11 Gu Medical Oncology Department, The M.D. Anderson Cancer Center, 77030 - Houston/US
  • 12 Clinical Oncology Department, Janssen Research & Development, LLC, 90024 - Los Angeles/US
  • 13 Clinical Oncology Department, Janssen Research & Development, LLC, 08560 - Titusville/US
  • 14 Department Of Oncology Translational Research, Janssen Research & Development, LLC, 19477 - Spring House/US
  • 15 Department Of Oncology Diagnostics, Janssen Research & Development, LLC, 08869 - Raritan/US
  • 16 Clinical Oncology Department, Janssen Research & Development, LLC, 08807 - Bridgewater/US
  • 17 Department Of Medical Oncology, BC Cancer - Vancouver, V5Z 4E6 - Vancouver/CA

Resources

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Abstract 1806P

Background

The randomized, double-blind, phase 3 MAGNITUDE study evaluated NIRA+AAP vs placebo and AAP (PBO+AAP) as 1st line therapy for mCRPC that was HRR+ based on targeted next-generation sequencing of tumor tissue and/or plasma-based assays.1 Here we aimed to assess treatment efficacy by assay.

Methods

Tumor tissue and/or plasma was collected from mCRPC patients (pts) who consented to the pre-screening protocol and tested using local tissue assays or centrally using the Foundation Medicine FoundationOne®CDx (F1CDX®) tissue assay or Agilent-Resolution Bioscience Resolution HRD™ Plasma assay. Pts HRR+ (BRCA1, BRCA2, FANCA, PALB2, CHEK2, BRIP1, HDAC2, ATM, CDK12) were randomized 1:1 to receive NIRA+AAP or PBO+AAP (NCT03748641). Primary (radiographic progression-free survival, rPFS) and secondary end-points (time to cytotoxic chemotherapy, TCC; time to symptomatic progression, TSP; and overall survival, OS) are reported for interim analysis 2 for each subgroup (events [NIRA+AAP/PBO+AAP], Hazard ratio and 95% CI).

Results

Overall, 423 pts were HRR+ with 225 BRCA+. Pts, 159 (96), were HRR+ (BRCA+) with both assays, the remaining pts were positive with either tissue/plasma (Table). Pts, 124 (62) HRR+ (BRCA+), were tissue positive but plasma negative, and 38 (17) HRR+ (BRCA+) pts were positive with plasma, but tissue negative. Hazard ratios for end-points, except OS, had p<0.05 for pts BRCA positive by either assay, with similar results for HRR+ pts.

Table: 1806P

Population, n (NIRA+APP / PBO+APP) rPFS TCC TSP OS
BRCA+ Overall 113/112 57/78 0.55 (0.39-0.78) 28/44 0.56 (0.35-0.90) 31/51 0.54 (0.35-0.85) 43/49 0.88 (0.58-1.34)
Plasma 71/79 0.63 (0.42-0.96) 0.49 (0.28-0.87) 0.51 (0.30-0.89) 0.88 (0.53-1.46)
Tissue 76/86 0.51 (0.33-0.77) 0.44 (0.24-0.82) 0.50 (0.28-0.89) 0.83 (0.49-1.40)
All HRR Overall 212/211 124/140 0.76 (0.60-0.97) 57/77 0.67 (0.47-0.94) 54/83 0.60 (0.42, 0.84) 90/89 1.01 (0.75-1.36)
Plasma 129/148 0.77 (0.57-1.04) 0.60 (0.39-0.92) 0.58 (0.38-0.88) 1.04 (0.73-1.49)
Tissue 144/147 0.80 (0.59-1.08) 0.62 (0.40-0.96) 0.56 (0.36-0.86) 0.97 (0.67-1.42)

Conclusions

Clinically meaningful benefit from NIRA+AAP are similar for BRCA+ pts detected by either tissue or plasma-based assays. Positivity by either test is sufficient to guide treatment decisions. 1. Efstathiou E, et al. J Clin Oncol. 2023;41(suppl 6):170.

Clinical trial identification

NCT03748641.

Editorial acknowledgement

Legal entity responsible for the study

Janssen Research & Development, LLC.

Funding

Janssen Research & Development, LLC.

Disclosure

G. Attard: Financial Interests, Personal, Invited Speaker: Janssen, Astellas, AstraZeneca; Financial Interests, Personal, Advisory Board: Janssen, Astellas, Novartis, Bayer, AstraZeneca, Pfizer, Sanofi, Sapience, Orion, Novartis; Financial Interests, Personal, Royalties, Included in list of rewards to discoverers of abiraterone: Institute of Cancer Research; Financial Interests, Institutional, Invited Speaker: Artera, Veracyte, Janssen, Novartis, Pfizer; Financial Interests, Institutional, Research Grant: Janssen, Astellas, Novartis; Non-Financial Interests, Principal Investigator: Janssen, Astellas; Non-Financial Interests, Advisory Role: Janssen, AstraZeneca; Non-Financial Interests, Project Lead: Artera, Veracyte. S.K. Sandhu: Financial Interests, Institutional, Advisory Board, I have served on advisory boards for BMS. The contracts for my role are set up with the institution and the funds go to a research fund at Peter MacCallum Cancer Centre: BMS; Financial Interests, Institutional, Advisory Board, I have served on advisory boards for MSD. The e contracts for my role are set up with the institution and the funds go to a research fund at Peter MacCallum Cancer Centre: Merck Sharp and Dohme; Financial Interests, Institutional, Advisory Board, I have served on advisory boards for AstraZeneca. The contracts for my role as an advisor are set up with the institution and the funds go to a research fund at Peter MacCallum Cancer Centre: AstraZeneca; Financial Interests, Institutional, Advisory Board, I have served on advisory boards for Novartis. The contracts for my role as an advisor are set up with the institution and the funds go to a research fund at Peter MacCallum Cancer Centre: Novartis; Financial Interests, Institutional, Advisory Board, I have served on an advisory board for Merck Serono. The contracts for my service are set up with the institution and funds go into a research fund at the Peter MacCallum Cancer Centre: Merck Serono; Financial Interests, Institutional, Research Grant, My institution receives grant funding to run an investigator initiated trial that I lead: Novartis, Genentech, Amgen, AstraZeneca, Merck Serono, Merck Sharp and Dohme; Financial Interests, Institutional, Funding, Pfizer are providing funding to my institution for the conduct of an investigator initiated clinical trial: Pfizer; Non-Financial Interests, Principal Investigator, I am a principal investigator on several of Janssen sponsored studies and don't receive any renumeration for this: Janssen; Non-Financial Interests, Principal Investigator, I am a principal investigator on several Novartis sponsored studies and don’t receive any renumeration for this: Novartis; Non-Financial Interests, Principal Investigator, I am a principal investigator on several of Genentech sponsored studies and don't receive any renumeration for this: Genentech; Non-Financial Interests, Principal Investigator, I am a principal investigator on several of BMS sponsored studies and don't receive any renumeration for this: BMS; Non-Financial Interests, Other, I serve on the Independent Safety and Data Monitoring committee for 2 of Novartis sponsored studies and don’t receive any compensation for this: Novartis; Non-Financial Interests, Principal Investigator, I am the Principal Investigator for several AstraZeneca sponsored studies and am not remunerated for this: AstraZeneca; Non-Financial Interests, Other, I serve on the steering committee for several Janssen sponsored trials and i do not receive compensation for this: Janssen; Non-Financial Interests, Other, I serve on the steering committee for one AstraZeneca sponsored trial and I do not receive compensation for this: AstraZeneca; Non-Financial Interests, Other, I serve on the steering committee for one Genentech sponsored trials and I do not receive compensation for this: Genentech; Non-Financial Interests, Other, I serve on the steering committee for a BMS sponsored trial and I do not receive renumeration for this: BMS. D. Rathkopf: Financial Interests, Trial Chair: Janssen; Financial Interests, Steering Committee Member: Janssen, Genentech; Financial Interests, Institutional, Research Grant, Clinical Trial Grant: Genentech; Non-Financial Interests, Advisory Role: Janssen, Genentech, AstraZeneca, Myovant, Bayer, BMS; Non-Financial Interests, Principal Investigator: Janssen, Genentech, Promontory, Celgene/BMS. E. Castro: Financial Interests, Personal, Advisory Board: Astellas, AstraZeneca, Janssen, MSD, Bayer, Pfizer; Financial Interests, Personal, Invited Speaker: Astellas, AstraZeneca, Janssen, Clovis, Pfizer; Financial Interests, Personal, Writing Engagement: Pfizer; Financial Interests, Institutional, Funding: AstraZeneca, Pfizer; Financial Interests, Institutional, Research Grant: Janssen, Bayer; Financial Interests, Institutional, Local PI: Janssen, Pfizer. M. Saad: Financial Interests, Speaker, Consultant, Advisor: AstraZeneca, BMS, Janssen, Merck, MSD, Novartis, Viatris; Financial Interests, Research Funding: Janssen, MSD; Financial Interests, Other, Honoraria: Amgen, Astellas, Cipla, Eisai, Ipsen, Pfizer. M.R. Smith: Financial Interests, Speaker, Consultant, Advisor: Amgen, Astellas, Bayer, Janssen, Lilly, Novartis, Pfizer; Financial Interests, Institutional, Research Funding: Bayer, ESSA, Janssen, Lilly, ORIC. E.J.J. Small: Financial Interests, Speaker, Consultant, Advisor: Fortis, Janssen, Teon Therapeutics; Financial Interests, Stocks/Shares: Fortis, Harpoon Therapeutics, Teon Therapeutics. D. Olmos: Financial Interests, Institutional, Advisory Role: AstraZeneca, Bayer, Janssen; Financial Interests, Speaker, Consultant, Advisor: Bayer, Clovis, Daiichi Sankyo, Janssen, MSD; Financial Interests, Institutional, Research Funding: Astellas, AstraZeneca, Bayer, Genentech/Roche, Janssen, MSD, Pfizer, Tokai. A.J.P.D.S. Gomes: Financial Interests, Speaker’s Bureau: Astellas, Bayer, Janssen; Financial Interests, Research Funding: AstraZeneca, Bayer, Janssen, MSD, Roche; Financial Interests, Advisory Role: Janssen; Financial Interests, Other, Honoraria: Astellas, AstraZeneca, Bayer, Janssen. G. Roubaud: Financial Interests, Speaker, Consultant, Advisor: Astellas, Janssen, MSD, Pfizer; Financial Interests, Research Funding: Bayer. B. Zurawski: Financial Interests, Speaker, Consultant, Advisor: Astellas, Roche; Financial Interests, Funding: BMS, GSK, Janssen, MSD, Merck Serono, Novartis, Roche. E. Efstathiou: Financial Interests, Speaker, Consultant, Advisor: Astellas, AstraZeneca, MSD, Myovant, Pfizer, Sanofi; Financial Interests, Research Funding: Astellas, AstraZeneca, MSD, Myovant, Pfizer, Sanofi. D. Wu, B. Diorio, K. Urtishak, U. Singh, Y. Xu, A. Lopez-Gitlitz, A. del Corral: Financial Interests, Full or part-time Employment: Janssen; Financial Interests, Stocks/Shares: Janssen. K.N.N. Chi: Financial Interests, Personal, Invited Speaker: Astellas, AstraZeneca, Janssen, Point Biopharma, Roche; Financial Interests, Personal, Advisory Board: AstraZeneca, AstraZeneca, Janssen, Merck, Novartis, Pfizer, Point Biopharma, Roche, BMS; Financial Interests, Institutional, Steering Committee Member: AstraZeneca, Janssen, Novartis, Roche; Financial Interests, Institutional, Trial Chair: AstraZeneca, Arvinas, Janssen, Novartis; Financial Interests, Institutional, Local PI: Arvinas.

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