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Survival results are 'immature' when too few patients have died (or progressed) for the comparison to be reliable, so medians are 'not reached' and confidence intervals are wide. Mature data come with time and events; early positive looks can fade or strengthen.
Trials pre-specify the number of events needed for each analysis (the information fraction at an interim); with fewer events the hazard ratio is unstable and the median cannot be estimated. Regulators accept immature OS if PFS is positive and there is no detriment, but require the final analysis as a post-marketing commitment; ADAURA and KEYNOTE-522 were approved on DFS/EFS with OS immature, and both later matured positively, whereas other trials' early OS trends vanished. 'Not reached' medians in the experimental arm are a favourable sign but not a result. Censoring marks patients still event-free at the cut-off, and heavy early censoring (dropouts, loss to follow-up) can bias curves.
Shares Landmark and milestone survival (5-year survival, median follow-up), Kaplan-Meier curve, censoring and proportional hazards, ADAURA, Hazard ratio (HR).
Shares Statistical power, sample size and re-estimation, Primary, secondary and co-primary endpoints, Interim analysis, readout and data cut-off, Hazard ratio (HR).
Shares Statistical power, sample size and re-estimation, Primary, secondary and co-primary endpoints, Interim analysis, readout and data cut-off, ADAURA.
Shares Kaplan-Meier curve, censoring and proportional hazards, Hazard ratio (HR), Overall survival (OS).
Shares Kaplan-Meier curve, censoring and proportional hazards, Hazard ratio (HR), Overall survival (OS).
Shares Statistical power, sample size and re-estimation, Kaplan-Meier curve, censoring and proportional hazards, Hazard ratio (HR).
Shares Statistical power, sample size and re-estimation, Primary, secondary and co-primary endpoints, Interim analysis, readout and data cut-off.
Shares Kaplan-Meier curve, censoring and proportional hazards, Overall survival (OS).