1781P - Health-related quality of life (HRQoL) deterioration-free survival (DetFS) by prostate-specific antigen (PSA) decline in darolutamide (DARO)-treated patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) from ARAMIS

Background

In ARAMIS (NCT02200614), DARO plus androgen-deprivation therapy (ADT) significantly increased metastasis-free survival by nearly 2 years and reduced the risk of death by 31% in patients (pts) with nmCRPC. DARO also significantly delayed time to deterioration of HRQoL and had a positive impact on local disease recurrence and symptom control. We report the effect of DARO on HRQoL DetFS by PSA decline in ARAMIS.

Methods

Pts with nmCRPC were randomized 2:1 to DARO or placebo, both with ADT. Using the primary analysis data cutoff (Sept 3, 2018), DARO-treated pts were grouped by PSA decline from baseline at wk 16 of ≥90% (PSA90), ≥50% to <90% (PSA50-90), and <50% (PSA50). DetFS was defined as the time from randomization until the earliest event of deterioration in HRQoL (EORTC Quality of Life Questionnaire Prostate Cancer Module urinary and bowel symptoms subscales and Functional Assessment of Cancer Therapy-Prostate [FACT-P] prostate cancer subscale [PCS] and Total), metastasis, death, or treatment discontinuation. Median (95% CIs) DetFS was calculated using Kaplan-Meier estimates.

Results

Of 955 DARO pts, 899 had PSA values at wk 16 and 403 (44.8%) achieved PSA90. Pts achieving PSA90 decline had longer median DetFS of HRQoL for urinary and bowel symptoms and for FACT-P Total and PCS vs those with PSA50-90 and <50% PSA decline (Table). For pts with PSA90, PSA50-90, and <50% PSA decline, 3-year DetFS rates were 38.0%, 31.2%, and 14.6% for urinary symptoms and 33.8%, 17.4%, and 13.3% for bowel symptoms.

Table: 1781P

HRQoL DetFS in DARO-treated pts by PSA decline from baseline at wk 16

NR, not reached.

Conclusions

In ARAMIS, a high proportion of DARO pts achieved PSA90. DARO demonstrated local symptom control for urinary and bowel measures and better HRQoL in pts who achieved PSA90. These findings confirm the cancer control and HRQoL benefits of early DARO treatment for pts with nmCRPC.

Clinical trial identification

NCT02200614.

Editorial acknowledgement

Medical writing support was provided by Michelle McDermott, of OPEN Health Communications (London, UK).

Legal entity responsible for the study

Bayer AG and Orion Pharma.

Funding

Bayer AG and Orion Pharma.

Disclosure

A.K. Morgans: Financial Interests, Personal, Other, Honoraria: Advanced Accelerator Applications, Astellas, AstraZeneca, Bayer, Clovis, Exelixis, Genentech, Janssen, Merck, Myovant, Pfizer, Sanofi, Telix; Financial Interests, Personal, Other, travel support: Sanofi; Financial Interests, Institutional, Research Funding: Astellas, AstraZeneca, Bayer, Genentech, Myovant, Sanofi, Seattle Genetics. C. Sweeney: Financial Interests, Personal, Advisory Board, Consultancy: Genentech_Roche, Bayer, Astellas, Pfizer, Pfizer, Sanofi, Lilly; Financial Interests, Personal, Other, Consultancy: Janssen; Financial Interests, Personal, Advisory Board: Point, Cellcentric; Financial Interests, Personal, Stocks/Shares: Leuchemix; Financial Interests, Institutional, Research Grant: Bayer, Janssen, Astellas, Pfizer, Dendreon, Sanofi. C. Wallis: Financial Interests, Personal, Other, Honoraria: Bayer, EMD Serono, Knight Therapeutics, Haymarket Media, Science & Medicine Canada, TerSera Canada, Tolmar Pharmaceuticals Canada; Financial Interests, Personal, Speaker, Consultant, Advisor: Janssen Oncology, SESEN Bio, Precision Point Specialty LLC; Financial Interests, Institutional, Research Funding: Knight Therapeutics. S. Halabi: Financial Interests, Personal, Other, Member of DSMB: Sanofi, Aveo Oncology, BMS, Janssen; Financial Interests, Institutional, Funding: ASCO. A.J. Armstrong: Financial Interests, Personal, Advisory Role: Bayer, Pfizer, Astellas Scientific and Medical Affairs Inc, AstraZeneca, Merck, BMS, Janssen, FORMA Therapeutics, Novartis, Exelixis, Myovant Sciences, GoodRx, Epic Sciences, IDEAYA Biosciences; Financial Interests, Personal, Other, travel, accommodations, expenses: Astellas Scientific and Medical Affairs Inc; Financial Interests, Personal, Licencing Fees or royalty for IP: Circulating tumor cell novel capture technologies; Financial Interests, Institutional, Research Funding: Dendreon, Bayer, Pfizer, Novartis, Janssen Oncology, Astellas Pharma, Gilead Sciences, Roche/Genentech, BMS, Constellation Pharmaceuticals, Merck, AstraZeneca, BeiGene, Amgen, FORMA Therapeutics. P. Adorjan: Financial Interests, Personal, Full or part-time Employment: Bayer; Financial Interests, Personal, Stocks or ownership: Biogen. A.F. Mohamed, F. Verholen, S. Srinivasan: Financial Interests, Personal, Full or part-time Employment: Bayer. M. Grimm: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, Ipsen Pharma, Merck Serono, MSD, Pfizer, EUSA, Janssen, Oncinfo; Financial Interests, Personal, Advisory Board: AstraZeneca, Bayer, BMS, EUSA Pharma, Ipsen Pharma, Merck Serono, MSD, Pfizer, Roche, Eisai, Takeda, Janssen Cilag, Gilead, Novartis; Financial Interests, Personal, Member of Board of Directors: Deutsche Gesellschaft für Urologie; Financial Interests, Personal and Institutional, Coordinating PI: BMS; Financial Interests, Institutional, Local PI: Intuitive Surgical; Financial Interests, Institutional, Coordinating PI: Bayer.