Clinical benefit according to ESMO-MCBS V.1.1 and concordance rate between ESMO Framework in this study and ESMO-MCBS scorecards
Trial name | Intervention group | PO | PO control group | PO gain | PO HR (95% CI) | Adjustments | ESMO-MCBS V.1.1 | Scorecards |
KATHERINE | T-DM1 | DFS | 3-year: 77.0% | 3-year: 11.3% | 0.50 (0.39 to 0.64) | NA | A (form 1) | A |
EMILIA | T-DM1 | PFS and OS | 25.9 months | 4.0 months | 0.75 (0.64 to 0.88) | Improved HRQoL | 3 (form 2a) | 4 |
EV-301 | EV | OS | 8.97 months | 3.91 months | 0.70 (0.56 to 0.89) | NA | 4 (form 2a) | 4 |
DESTINY-Breast01 | DS-8201 | ORR | – | – | – | NA | 2 (form 3) | 2 |
DESTINY-Breast03 | DS-8201 | PFS (OS improved) | 2-year: 69.9% | 2-year: 7.5% | 0.64 (0.47 to 0.87) | NA | 3 (form 2a) | 4 |
DESTINY-Breast04 | DS-8201 | PFS (OS improved) | 16.8 months | 6.6 months | 0.64 (0.49 to 0.84) | NA | 4 (form 2a) | 4 |
DESTINY-Gastric01 | DS-8201 | ORR | 14% | 37% | – | NA | 2 (form 2c) | 4 |
DESTINY-Lung02 | DS-8201 | ORR | – | – | – | NA | 3 (form 3) | NA |
ASCENT | SG | PFS (OS improved) | 6.9 months | 4.9 months | 0.51 (0.41 to 0.62) | Increased toxicity/improved HRQoL | 4 (form 2a) | 4 |
TROPiCS-02 | SG | PFS (OS improved) | 11.2 months | 3.2 months | 0.79 (0.65 to 0.96) | NA | 1 (form 2a) | 3 |
TROPHY-U-01 | SG | ORR | – | – | – | NA | 3 (form 3) | NA |
NCT02422979 | CS | ORR | – | – | – | NA | 2 (form 3) | NA |
NCT03556345 | DV | ORR | – | – | – | NA | 2 (form 3) | NA |
NCT03507166 | DV | ORR | – | – | – | NA | 3 (form 3) | NA |
innovaTV 204 | TV | ORR | – | – | – | NA | 2 (form 3) | 2 |
SORAYA | MS | ORR | – | – | – | NA | 2 (form 3) | 2 |
CS, cetuximab saratolacan; DFS, disease-free survival; DV, disitamab vedotin; ESMO-MCBS, European Society for Medical Oncology Magnitude of Clinical Benefit Scale; EV, enfortumab vedotin; MS, mirvetuximab soravtansine ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PO, primary outcome; SG, sacituzumab govitecan; T-DM1, trastuzumab emtansine; TV, tisotumab vedotin.