Table 1

The ESMO-MCBS dual rule: implemented combined thresholds for the HR and the minimum absolute benefit (AB) gain for OS and PFS that could be considered as deserving the maximal preliminary grade.

Non-curative setting
Maximal preliminary gradePrimary endpoint (time-to-event)Criteria
OS - median (control)HR*AB gain
4≤12 months≤0.65AND≥3 months
>12 months≤0.70AND≥5 months
PFS- median (control)HR*AB gain
3≤6 months≤0.65AND≥1.5 months
>6 months≤0.65AND≥3 months
  • *Thresholds refer to the lower limit of the 95% CI.

  • ESMO, European Society for Medical Oncology; MCBS, Magnitude of Clinical Benefit Scale; OS, overall survival; PFS, progression-free survival.