ESMO Magnitude of Clinical Benefit Scale: Evaluation Forms version 1.1

The ESMO Magnitude of Clinical Benefit Scale uses a rational, structured and consistent approach to derive a relative ranking of the magnitude of clinically meaningful benefit that can be expected from a new anti-cancer treatment

There are several evaluation forms, which can be downloaded below:

Evaluation form 1

For new approaches to adjuvant therapy or new potentially curative therapies

Hyper mature data from studies that were un-blinded after compelling early results with subsequent access to the superior arm are contaminated, subsequently late intention to treat (ITT) follow-up data are not evaluable

Evaluation form 2a

For therapies that are not likely to be curative with primary endpoint of OS with separate sheets for:

  • IF median OS with the standard treatment is <12 months
  • IF median OS with the standard treatment is >12 months, <24 months
  • IF median OS with the standard treatment is >24 months

Evaluation form 2b

For therapies that are not likely to be curative with primary endpoint PFS with separate sheets for:

  • IF median PFS with standard treatment is <6 months
  • IF median PFS with standard treatment is >6 months

Evaluation form 2c

For therapies that are not likely to be curative with primary endpoint other than OS or PFS or equivalent (non-inferiority) studies

Evaluation form 3

For single-arm studies in “orphan diseases” and for diseases with “high unmet need” when primary outcome is PFS or ORR.