PROSELICA (NCT01308580) was a post-marketing requirement to demonstrate non-inferiority of C20 vs C25 in terms of overall survival (OS) in mCRPC pts who progressed on D.
Post-D mCRPC pts were randomized 1:1 to receive C25 or C20 (+ prednisone). To show non-inferiority of C20 (preservation of ≥ 50% of the incremental C25 efficacy over mitoxantrone in the TROPIC trial) with 95% confidence interval (CI), hazard ratio (HR) could not exceed 1.214 under a 1-sided 98.89% CI after interim analyses. Secondary endpoints: progression-free survival (PFS), prostate-specific antigen (PSA) and tumor response (TR), safety, HRQL (Functional Assessment of Cancer Therapy-Prostate [FACT-P] questionnaire) and pain response (PR; Present Pain Intensity score on McGill-Melzack scale). Post-hoc analyses assessed association of Grade 3–4 neutropenia on treatment and baseline (BL) neutrophil-lymphocyte ratio (NLR) with OS.
1200 pts were randomized (598 C20; 602 C25). BL pt characteristics were similar for C20 and C25. See Table for efficacy results. Rates of Grade 3–4 treatment-emergent adverse events were 39.7% C20, 54.5% C25. Change in FACT-P total score from BL was not significantly different for C20 and C25. Grade 3–4 neutropenia on treatment and BL NLR
In post-D mCRPC pts, C20 is non-inferior in terms of OS vs C25, meeting the study endpoint. Efficacy parameters favoured C25. Grade 3–4 neutropenia and low NLR may have prognostic value. Funding: Sanofi Genzyme.
Clinical trial identification
Legal entity responsible for the study
J.S. de Bono: Received honoraria from and provided a consulting/advisory role for Sanofi Genzyme. D. Ford: Received honoraria from and provided a consulting/advisory role for Janssen and Astellas, and received reimbursement for expenses from Astellas.
J. Carles: Provided a consulting/advisory role for Johson&Johnson, Astellas, Bayer, Amgen, Pfizer, and BMS, and has participated in a speakers bureau for Bayer.
G. Kacsó: Was employed by and provided a leadership role for RTC Amethyst, has received honoraria from Sanofi Genzyme, Astra-Zeneca, Janssen, Astellas, has provided a consulting/advisory role for Janssen and Astellas, has received funding from Janssen and CNCSIS.
M. Chadjaa: Is an employee of Sanofi Genzyme.
W. Zhang: Is an employee of Sanofi Genzyme and owns stock in Sanofi Genzyme.
J. Bernard: Is an employee of Sanofi Genzyme.
M. Eisenberger: Provided a consulting/advisory role for and received reimbursement for expenses from Astellas, Bayer and Sanofi Genzyme, has received honoraria from Sanofi Genzyme and research funding from Sanofi Genzyme, Tokai Pharmaceuticals and Genentech.
All other authors have declared no conflicts of interest.