Indirect comparison of reconstructed individual patient data from KEYNOTE-905/EV-303 and PURE-01: complementary analyses for interpreting event-free survival in muscle-invasive bladder cancer.
- 1Department of Medical Oncology, Comprehensive Cancer Center, IRCCS San Raffaele, Milan, Italy. Electronic address: [email protected].
- 2Department of Medical Oncology, Comprehensive Cancer Center, IRCCS San Raffaele, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy.
Abstract
Background
Neoadjuvant and perioperative immunotherapy have transformed the treatment landscape of muscle-invasive bladder cancer, with multiple strategies now available. In the absence of randomized head-to-head evidence, cross-trial comparisons are increasingly used to contextualize outcomes, but they may be affected by differences in study populations, treatment strategies, endpoint definitions, and follow-up maturity. We compared event-free survival (EFS) using reconstructed individual patient data from KEYNOTE-905/EV-303 and PURE-01.Patients and methods
Individual patient data were reconstructed from published Kaplan-Meier curves. EFS was compared using Kaplan-Meier estimates, Cox regression, and log-rank tests. Sensitivity analyses included proportional hazards assessment, restricted mean survival time, and common follow-up analyses at 12, 24, and 36 months.Results
The analysis included 325 patients (170 KEYNOTE-905/EV-303; 155 PURE-01) and 93 EFS events. EFS did not differ significantly between perioperative enfortumab vedotin-pembrolizumab and neoadjuvant pembrolizumab (hazard ratio 1.33, 95% confidence interval 0.87-2.03; P = 0.181), with evidence of nonproportional hazards (P = 0.021). Restricted mean survival time and common follow-up analyses yielded consistent results.Conclusions
This reconstructed indirect comparison does not permit inference on comparative efficacy or the contribution of individual therapeutic components. Differences in study populations, treatment strategies, and follow-up maturity warrant caution. Complementary survival analyses may help generate hypotheses for studies designed to disentangle individual agents and perioperative treatment phases.
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BibTeX
@article{maiorano2026indirect,
title = {{Indirect comparison of reconstructed individual patient data from KEYNOTE-905/EV-303 and PURE-01: complementary analyses for interpreting event-free survival in muscle-invasive bladder cancer.}},
author = {B A Maiorano and A Necchi},
journal = {ESMO open},
year = {2026},
month = sep,
doi = {10.1016/j.esmoop.2026.108597},
url = {https://europepmc.org/article/MED/42854586},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Indirect comparison of reconstructed individual patient data from KEYNOTE-905/EV-303 and PURE-01: complementary analyses for interpreting event-free survival in muscle-invasive bladder cancer.
AU - B A Maiorano
AU - A Necchi
PY - 2026
DA - 2026/09/22
JO - ESMO open
DO - 10.1016/j.esmoop.2026.108597
UR - https://europepmc.org/article/MED/42854586
AB - Background Neoadjuvant and perioperative immunotherapy have transformed the treatment landscape of muscle-invasive bladder cancer, with multiple strategies now available. In the absence of randomized head-to-head evidence, cross-trial comparisons are increasingly used to contextualize outcomes, but they may be affected by differences in study populations, treatment strategies, endpoint definitions, and follow-up maturity. We compared event-free survival (EFS) using reconstructed individual patient data from KEYNOTE-905/EV-303 and PURE-01.Patients and methods Individual patient data were reconstructed from published Kaplan-Meier curves. EFS was compared using Kaplan-Meier estimates, Cox regression, and log-rank tests. Sensitivity analyses included proportional hazards assessment, restricted mean survival time, and common follow-up analyses at 12, 24, and 36 months.Results The analysis included 325 patients (170 KEYNOTE-905/EV-303; 155 PURE-01) and 93 EFS events. EFS did not differ significantly between perioperative enfortumab vedotin-pembrolizumab and neoadjuvant pembrolizumab (hazard ratio 1.33, 95% confidence interval 0.87-2.03; P = 0.181), with evidence of nonproportional hazards (P = 0.021). Restricted mean survival time and common follow-up analyses yielded consistent results.Conclusions This reconstructed indirect comparison does not permit inference on comparative efficacy or the contribution of individual therapeutic components. Differences in study populations, treatment strategies, and follow-up maturity warrant caution. Complementary survival analyses may help generate hypotheses for studies designed to disentangle individual agents and perioperative treatment phases.
SN - 2059-7029
ER -