TY - JOUR
T1 - Patient-reported Outcomes in KEYLYNK-010
T2 - Pembrolizumab Plus Olaparib Versus Abiraterone or Enzalutamide for Participants with Biomarker-unselected, Previously Treated Metastatic Castration-resistant Prostate Cancer
AU - Mehra, Niven
AU - Antonarakis, Emmanuel S.
AU - Park, Se Hoon
AU - Goh, Jeffrey C.
AU - McDermott, Ray
AU - Sala Gonzalez, Nuria
AU - Fong, Peter C.
AU - Greil, Richard
AU - De Santis, Maria
AU - Yanez, Patricio Eduardo
AU - Huang, Yi Hsiu
AU - Begbie, Stephen D.
AU - Rey, Felipe
AU - Kramer, Gero
AU - Suzuki, Hiroyoshi
AU - Saretsky, Todd L.
AU - Ghate, Sameer R.
AU - Cui, Yi
AU - Hosius, Christian
AU - Yu, Evan Y.
N1 - Publisher Copyright:
Copyright © 2025 Merck & Co., Inc., Rahway, NJ, USA and its affiliates, The Author(s). Published by Elsevier B.V. All rights reserved.
PY - 2025/8/1
Y1 - 2025/8/1
N2 - BACKGROUND AND OBJECTIVE: Pembrolizumab plus olaparib did not significantly improve radiographic progression-free survival or overall survival versus a next-generation hormonal agent (NHA) in participants with biomarker-unselected, pretreated metastatic castration-resistant prostate cancer (mCRPC) in the phase 3 KEYLYNK-010 trial. We present prespecified patient-reported outcomes (PROs) from KEYLYNK-010. METHODS: Participants were randomly assigned 2:1 to receive pembrolizumab plus olaparib or an NHA (abiraterone acetate or enzalutamide). PROs were evaluated using the Brief Pain Inventory-Short Form (BPI-SF), Functional Assessment of Cancer Therapy-Prostate Cancer (FACT-P), and EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaires. The PRO endpoints included time to pain progression (TTPP) as per BPI-SF and the least squares mean (LSM) change from baseline to week 15 in FACT-P total, BPI-SF, and EQ-5D visual analog scale (VAS) scores. KEY FINDINGS AND LIMITATIONS: The PRO analysis population included 774 participants (pembrolizumab plus olaparib, n = 520; NHA, n = 254). The median follow-up was 18.7 (range, 6.1-31.7) mo. No meaningful differences were observed in TTPP for pembrolizumab plus olaparib versus NHA (median: 13.5 vs 12.0 mo; hazard ratio 0.95; 95% confidence interval 0.72-1.26). From baseline to week 15, no meaningful LSM differences were observed between the treatment groups in FACT-P total, BPI-SF, and EQ-5D VAS scores. Limitations include no formal hypothesis testing. CONCLUSIONS AND CLINICAL IMPLICATIONS: No meaningful differences were observed in health-related quality of life (HRQoL) or disease-related symptom scores for pembrolizumab plus olaparib versus NHA in participants with biomarker-unselected, pretreated mCRPC. These findings suggest that pembrolizumab plus olaparib did not negatively impact HRQoL in participants with pretreated mCRPC. CLINICAL TRIAL REGISTRY: NCT03834519.
AB - BACKGROUND AND OBJECTIVE: Pembrolizumab plus olaparib did not significantly improve radiographic progression-free survival or overall survival versus a next-generation hormonal agent (NHA) in participants with biomarker-unselected, pretreated metastatic castration-resistant prostate cancer (mCRPC) in the phase 3 KEYLYNK-010 trial. We present prespecified patient-reported outcomes (PROs) from KEYLYNK-010. METHODS: Participants were randomly assigned 2:1 to receive pembrolizumab plus olaparib or an NHA (abiraterone acetate or enzalutamide). PROs were evaluated using the Brief Pain Inventory-Short Form (BPI-SF), Functional Assessment of Cancer Therapy-Prostate Cancer (FACT-P), and EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaires. The PRO endpoints included time to pain progression (TTPP) as per BPI-SF and the least squares mean (LSM) change from baseline to week 15 in FACT-P total, BPI-SF, and EQ-5D visual analog scale (VAS) scores. KEY FINDINGS AND LIMITATIONS: The PRO analysis population included 774 participants (pembrolizumab plus olaparib, n = 520; NHA, n = 254). The median follow-up was 18.7 (range, 6.1-31.7) mo. No meaningful differences were observed in TTPP for pembrolizumab plus olaparib versus NHA (median: 13.5 vs 12.0 mo; hazard ratio 0.95; 95% confidence interval 0.72-1.26). From baseline to week 15, no meaningful LSM differences were observed between the treatment groups in FACT-P total, BPI-SF, and EQ-5D VAS scores. Limitations include no formal hypothesis testing. CONCLUSIONS AND CLINICAL IMPLICATIONS: No meaningful differences were observed in health-related quality of life (HRQoL) or disease-related symptom scores for pembrolizumab plus olaparib versus NHA in participants with biomarker-unselected, pretreated mCRPC. These findings suggest that pembrolizumab plus olaparib did not negatively impact HRQoL in participants with pretreated mCRPC. CLINICAL TRIAL REGISTRY: NCT03834519.
KW - Health-related quality of life
KW - Metastatic castration-resistant prostate cancer
KW - Next-generation hormonal agent
KW - Olaparib
KW - Pembrolizumab
UR - https://www.scopus.com/pages/publications/105016616605
U2 - 10.1016/j.euo.2025.04.018
DO - 10.1016/j.euo.2025.04.018
M3 - Article
C2 - 40685311
AN - SCOPUS:105016616605
SN - 2588-9311
VL - 8
SP - 1030
EP - 1040
JO - European urology oncology
JF - European urology oncology
IS - 4
ER -
