Table 2

Clinical benefit according to ESMO-MCBS V.1.1 and concordance rate between ESMO Framework in this study and ESMO-MCBS scorecards

Trial nameIntervention groupPOPO control groupPO gainPO HR (95% CI)AdjustmentsESMO-MCBS V.1.1Scorecards
KATHERINET-DM1DFS3-year: 77.0%3-year: 11.3%0.50 (0.39 to 0.64)NAA (form 1)A
EMILIAT-DM1PFS and OS25.9 months4.0 months0.75 (0.64 to 0.88)Improved HRQoL3 (form 2a)4
EV-301EVOS8.97 months3.91 months0.70 (0.56 to 0.89)NA4 (form 2a)4
DESTINY-Breast01DS-8201ORRNA2 (form 3)2
DESTINY-Breast03DS-8201PFS (OS improved)2-year: 69.9%2-year: 7.5%0.64 (0.47 to 0.87)NA3 (form 2a)4
DESTINY-Breast04DS-8201PFS (OS improved)16.8 months6.6 months0.64 (0.49 to 0.84)NA4 (form 2a)4
DESTINY-Gastric01DS-8201ORR14%37%NA2 (form 2c)4
DESTINY-Lung02DS-8201ORRNA3 (form 3)NA
ASCENTSGPFS (OS improved)6.9 months4.9 months0.51 (0.41 to 0.62)Increased toxicity/improved HRQoL4 (form 2a)4
TROPiCS-02SGPFS (OS improved)11.2 months3.2 months0.79 (0.65 to 0.96)NA1 (form 2a)3
TROPHY-U-01SGORRNA3 (form 3)NA
NCT02422979CSORRNA2 (form 3)NA
NCT03556345DVORRNA2 (form 3)NA
NCT03507166DVORRNA3 (form 3)NA
innovaTV 204TVORRNA2 (form 3)2
SORAYAMSORRNA2 (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.