Table 3.

ESMO Magnitude of Clinical Benefit Scale (MCBS) Form 3: Evaluation Scale for Benefit as Observed in Single Arm Studies in “Orphan Diseases” and for Diseases With “High Unmet Need” With Primary Outcome Progression-Free Survival or Objective Response Rate. Non-Curative Setting Grading 5 and 4 Indicates a Substantial Magnitude of Clinical Benefit³¹

Grade	Criteria
3	PFS ≥ 6 months ORR (PR + CR) ≥ 60% ORR (PR + CR) ≥ 20% - < 60% AND Duration of response ≥ 9 months
2	PFS ≥ 3 - < 6 months ORR (PR + CR) ≥ 40% - < 60% ORR (PR + CR) ≥ 20% - < 40% AND Duration of response ≥ 6 - < 9 months
1	PFS 2 - < 3 months ORR (PR + CR) ≥ 20%–< 40% AND Duration of response < 6 months ORR (PR + CR) ≥ 10% - < 20% AND Duration of response ≥ 6 months

Adjustments: Final adjusted magnitude of clinical benefit grade.

Downgrade 1 level if there are ≥30% grade 3–4 toxicities impacting daily well-being*.

Upgrade 1 level if improved Quality of Life.

Upgrade 1 level for confirmatory, adequately sized, phase 4 experience.

Abbreviations: PFS: Progression-Free Survival; ORR: Objective response rate. ESMO: European Society for Medical Oncology.