1638P - Enzalutamide (enza) with or without leuprolide in patients (pts) with high-risk biochemically recurrent (hrBCR) prostate cancer (PC): EMBARK post hoc analysis by age

Background

Pts diagnosed with PC aged >70 years (y) are at greater risk of PC-related death vs pts diagnosed aged ≤70 y. In EMBARK, enza ± leuprolide significantly prolonged metastasis-free survival (MFS) by blinded independent central review vs leuprolide alone in pts with PC and hrBCR. Here, we present a post hoc analysis of outcomes by age.

Methods

EMBARK, a phase 3 trial (NCT02319837), included pts after local therapy with hrBCR: prostate-specific antigen (PSA) doubling time ≤9 months and PSA ≥2 ng/mL above nadir post radiotherapy (RT) or ≥1 ng/mL after radical prostatectomy (RP) ± postoperative RT. Pts were randomised (1:1:1) to enza + leuprolide (combo), leuprolide alone, or enza monotherapy (mono). A post hoc analysis of MFS and safety by median age in EMBARK was conducted (<70 vs ≥70 y).

Results

In total, 543 pts (50.8%) were aged

Conclusions

In this post hoc analysis from EMBARK, similar treatment benefits for enza combo and mono vs leuprolide alone were seen in pts with hrBCR aged <70 and ≥70 y. Tx-related serious AEs were more common in older pts, but were low regardless of age.

Clinical trial identification

NCT02319837.

Editorial acknowledgement

Medical writing and editorial support was provided by Adam Anazim, BSc, and Rosie Henderson, MSc, of Onyx (a division of Prime, London, UK) funded by Pfizer Inc. and Astellas Pharma Inc., co-developers of enzalutamide.

Legal entity responsible for the study

Pfizer Inc. and Astellas Pharma Inc.

Funding

The study was sponsored by Pfizer Inc. and Astellas Pharma Inc., the co-developers of enzalutamide.

Disclosure

N.D. Shore: Financial Interests, Personal, Advisory Board: AbbVie, Amgen, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Boston Scientific, Cold Genesys, Dendreon, Exact Imaging, Genesis Care Us, Invitae, Janssen, MDxhealth, Merck, Myovant, Myriad, Nymox, Pacific Edge, Pfizer, Propella, Sanofi Genzyme, Speciality Networks, Tolmar, Urogen, Clarity, Lantheus, Lilly, Photocure, Telix, Photocure, Asieris, Alessa Therapeutics, Arquer, Fize medical, GConcology, Guardant, Ferring, Foundation Medicine, Immunitybio, Incyte, Minomic, NGM, Nonagen, Novartis, PlatformQ, Promaxo, Protara, Accord, Antev, Aura biosciences, Sumitomo; Financial Interests, Personal, Member of Board of Directors: Photocure, Alessa Theraputics; Financial Interests, Personal and Institutional, Local PI: AstraZeneca, Bayer, Aura, Exact Imaging, Janssen, Merck, Myovant, Novartis, Pfizer, Propella, Bristol Myers Squibb, Dendreon, Pfizer, Urogen; Financial Interests, Institutional, Local PI: Alessa, GC Oncology, FORMA therapeutics, Pacific Edge, Point Biopharma, The MT group, Theralase, Verity, Astellas, Palette Life Sciences, Steba, Zenflow. U. De Giorgi: Financial Interests, Personal, Advisory Board: Pfizer, BMS, MSD, PharmaMar, Astellas, Bayer, Ipsen, Novartis, EISAI, Janssen; Financial Interests, Personal, Invited Speaker: Roche, BMS, Astrazeneca, Merck; Financial Interests, Institutional, Research Grant: Astrazeneca, Sanofi, Roche. M.E. Gleave: Financial Interests, Personal, Stocks or ownership: OncoGenex Technologies, Sustained Therapeutics, Sikta Pharmaceuticals; Financial Interests, Personal, Speaker, Consultant, Advisor: Astellas Pharma Inc., AstraZeneca, Bayer, GDx, Johnson & Johnson Innovative Medicine (formerly Janssen), Sanofi, Pfizer Inc., Roche; Financial Interests, Personal, Other, Holds patents for OGX-011, OGX-427, ST-CP, and ST-POP: OGX-011, OGX-427, ST-CP, and ST-POP. M. Kalac: Financial Interests, Institutional, Full or part-time Employment: Pfizer; Financial Interests, Personal, Stocks/Shares: Pfizer. Y. Tang: Financial Interests, Personal, Full or part-time Employment: Pfizer Inc.; Financial Interests, Personal, Stocks/Shares: Pfizer Inc. R. Croitoru: Financial Interests, Personal, Full or part-time Employment: Astellas Pharma Inc.; Financial Interests, Personal, Stocks/Shares: Astellas Pharma Inc. M. Rosales: Financial Interests, Institutional, Full or part-time Employment, Current employer: Astellas Pharma; Financial Interests, Institutional, Other, Current Employer: Astellas Pharma; Non-Financial Interests, Member: ASCO. M. Huynh: Financial Interests, Personal, Advisory Board: Astellas; Financial Interests, Personal, Invited Speaker: Knight Therapeutics. I. Jan de Jong: Financial Interests, Personal, Other, educational speakers fee: Bayer, AstraZeneca. F.M. Carcano: Financial Interests, Personal, Invited Speaker, Small group updating meeting in Brazil: Adium, Janssen, Ipsen. S.J. Freedland: Financial Interests, Personal, Advisory Board: Merck, AstraZeneca, Pfizer, Astellas, Janssen, Bayer, Myovant, Sanofi, Novartis, Eli Lilly. All other authors have declared no conflicts of interest.