TALAPRO-3 (NCT04821622) demonstrated statistically significant and clinically meaningful improvement in investigator-assessed radiographic progression-free survival with TALA + ENZA (n=300) vs PBO + ENZA (n=299) in men with HRR-deficient mCSPC (HR 0.48; 95% CI 0.36–0.65; p<0.001). Here, we report PRO endpoints.
Prespecified PROs were evaluated per EORTC QLQ-C30, EORTC QLQ-PR25, and BPI-SF. Higher global health status/quality of life (GHS/QoL) and functional scale scores, and lower symptom scale and pain scores, represent better QoL. Differences in the estimated overall mean scores between arms were assessed by a longitudinal mixed-effects model for repeated measures (MMRM). Time to [definitive] deterioration (TT[D]D) in EORTC measures was a ≥10-point within patient change from baseline (BL) that was subsequently maintained. TTD in worst pain per the BPI-SF was the first of either a ≥2-point increase from BL or an increase in WHO analgesic usage score. A stratified log-rank test and Cox proportional hazards model were used to compare time-to-events between arms.
At data cutoff (Feb 18, 2026), 474/599 men (240, TALA + ENZA; 234, PBO + ENZA) had 1 BL + ≥1 post-BL PRO assessment. Median treatment duration was 35.0 mo for TALA and 35.9 mo for ENZA (TALA arm), and 32.9 mo for both PBO and ENZA (ENZA arm). There were no clinically meaningful differences between arms (≥5-point threshold) in overall estimated mean scores in GHS/QoL, functioning, and symptom scales, except appetite loss. TTDD in GHS/QoL and urinary symptoms and TTD in worst pain were comparable between arms (Table). Table: 2222RO
| MMRM | Estimated Overall Mean Score Difference,(TALA + ENZA) – (PBO + ENZA) [95% CI] | |
| QLQ-C30 functioning (scale 0–100) | GHS/QoL | –3.7 [–6.5 to –1.0] |
| Physical | –2.5 [–5.1 to 0.1] | |
| Role | –2.7 [–6.0 to 0.6] | |
| Cognitive | –0.9 [–3.5 to 1.7] | |
| Emotional | –1.3 [–3.7 to 1.0] | |
| Social | –1.9 [–4.9 to 1.1] | |
| QLQ-C30 symptoms (scale 0–100) | Fatigue | 3.2 [0.2 to 6.2] |
| Nausea + vomiting | 1.2 [0.2 to 2.3] | |
| Pain | 0.4 [–2.4 to 3.2] | |
| Appetite loss | 5.2 [2.5 to 8.0] | |
| Constipation | 4.2 [1.3 to 7.1] | |
| Diarrhea | 0.5 [–1.5 to 2.5] | |
| Dyspnea | 3.0 [0.1 to 5.8] | |
| Insomnia | 2.6 [–0.9 to 6.0] | |
| Time-to-Event | TALA + ENZA vs PBO + ENZA HR [95% CI] | |
| TTDD | GHS/QoL | 1.16 [0.85 to 1.58] |
| Urinary symptoms | 0.94 [0.61 to 1.44] | |
| TTD | BPI-SF–worst pain | 0.82 [0.61 to 1.11] |
Adding TALA to ENZA generally did not result in clinically meaningful differences in PROs vs ENZA alone. These data further inform the benefit–risk profile of TALA + ENZA in men with HRR-deficient mCSPC.
NCT04821622.
Medical writing support, under the guidance of the authors, was provided by Vasupradha Vethantham, PhD, and Emily Messina, PhD, employees from the Publications and Medical Affairs Division of Omnicom Health Medical Communications, and was funded by Pfizer, New York, NY, USA, in accordance with Good Publication Practice 2022 guidelines (Ann Intern Med. 2022;175:1298-1304).
Pfizer.
Pfizer Inc.