Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

e-Poster Display Session

222P - Tolerability and treatment response to darolutamide (DARO) in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) in the phase III ARAMIS trial

Date

22 Nov 2020

Session

e-Poster Display Session

Topics

Tumour Site

Prostate Cancer

Presenters

Matthew R. Smith

Citation

Annals of Oncology (2020) 31 (suppl_6): S1325-S1333. 10.1016/annonc/annonc369

Authors

M.R. Smith1, N.D. Shore2, T.L.J. Tammela3, M. Le Berre4, O. Petrenciuc5, C. Zurth6, I. Kuss7, K. Fizazi8

Author affiliations

  • 1 Massachusetts General Hospital Cancer Center And Harvard Medical School, Urologic Oncology, 02114 - Boston/US
  • 2 Carolina Urologic Research Center, Atlantic Urology Clinics, Myrtle Beach/US
  • 3 Tampere University Hospital And Tampere University, Urology, Tampere/FI
  • 4 Bayer Healthcare Sas, Pharmaceuticals, Loos/FR
  • 5 Bayer Healthcare, Pharmaceuticals, Whippany/US
  • 6 Bayer Ag, Clinical Pharmacokinetics Oncology, Berlin/DE
  • 7 Bayer Ag, Pharmaceuticals, Berlin/DE
  • 8 Institut Gustave Roussy, University Of Paris-saclay, Cancer Medicine, 94805 - Villejuif/FR

Resources

Login to get immediate access to this content.

If you do not have an ESMO account, please create one for free.

Abstract 222P

Background

Androgen receptor inhibitors (ARIs) approved for treating nmCRPC are associated in varying degrees with certain adverse events (AEs), e.g., fatigue, risk of falls or rash. In phase III studies, dose modification and discontinuation due to AEs was higher with ARIs vs placebo. Reduced dose, compliance patterns and treatment adherence may impact drug efficacy. Tolerability of DARO and association of prostate-specific antigen (PSA) decline in response to DARO treatment with metastasis-free survival (MFS) in the ARAMIS trial are reviewed.

Methods

1509 patients with nmCRPC and PSA doubling time (PSADT) ≤10 months were randomised 2:1 to DARO 600 mg twice daily (n=955) or placebo (PBO; n=554) while continuing androgen deprivation therapy. AEs and dose modifications were assessed every 16 weeks. The association between PSA decline from baseline in response to DARO treatment and MFS was evaluated using the Cox proportional hazards model. An association with overall survival will be investigated.

Results

DARO was well tolerated; 97.2% of patients on DARO received the full planned dose. Permanent treatment discontinuation due to AEs was similar for patients treated with DARO as compared with PBO (8.9% vs 8.7%). Few patients had dose modifications for AEs or any other reason (15.2% vs 9.7% for DARO vs PBO). Almost all of the patients on DARO who had dose interruptions or modifications were able to resume and re-establish the indicated dose (91.7% vs 88.9% for DARO vs PBO). In the ARAMIS trial, 50.9% of patients on DARO had a maximal PSA response (≥90% decrease from baseline) vs 1.8% of patients on PBO. Pharmacodynamic modelling showed that longer MFS was positively associated with maximum decrease in PSA from baseline. Prostate cancer-related quality of life was maintained with DARO treatment.

Conclusions

Favourable tolerability of DARO at the recommended dose of 600 mg twice daily was associated with low rates of dose reduction and treatment discontinuation, which in turn may lead to extended survival with longer duration of treatment with DARO. It is important to further assess the real-world tolerance of different ARIs in men with nmCRPC.

Clinical trial identification

NCT02200614.

Editorial acknowledgement

Editorial assistance was provided by Lucy Smithers, PhD, and Annabel Ola, MSc, both of Scion, London, and supported by Bayer.

Legal entity responsible for the study

Bayer AG and Orion Pharma.

Funding

Bayer AG and Orion Pharma.

Disclosure

M.R. Smith: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Bayer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Amgen; Honoraria (self), Advisory/Consultancy: Astellas; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Janssen; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Lilly; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Pfizer. N.D. Shore: Advisory/Consultancy, Speaker Bureau/Expert testimony: Bayer; Advisory/Consultancy, Speaker Bureau/Expert testimony: Janssen; Advisory/Consultancy: Tolmar; Advisory/Consultancy: Ferring; Advisory/Consultancy: Medivation; Advisory/Consultancy: Amgen; Advisory/Consultancy: Pfizer; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Genentech/Roche; Advisory/Consultancy: Myovant Sciences; Advisory/Consultancy: Astellas Pharma; Advisory/Consultancy: Merck; Advisory/Consultancy, Speaker Bureau/Expert testimony: Dendreon. T.L.J. Tammela: Research grant/Funding (institution): Bayer; Advisory/Consultancy: Janssen; Research grant/Funding (institution): Lidds AB; Research grant/Funding (institution): Astellas Pharma. M-A. Le Berre: Full/Part-time employment: Bayer. O. Petrenciuc: Full/Part-time employment: Bayer. C. Zurth: Full/Part-time employment: Bayer. I. Kuss: Shareholder/Stockholder/Stock options, Full/Part-time employment: Bayer. K. Fizazi: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Honoraria (self), Advisory/Consultancy: Bayer; Honoraria (self), Advisory/Consultancy: Astellas Pharma; Honoraria (self), Advisory/Consultancy: Sanofi; Advisory/Consultancy: Orion Pharma GmbH; Advisory/Consultancy: Curevac; Honoraria (institution): AstraZeneca; Advisory/Consultancy: ESSA; Advisory/Consultancy, Travel/Accommodation/Expenses: Amgen; Advisory/Consultancy: Roche.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.