Table 3.
Outcome measures reported in the 12 reviewed ESMO 2022 trial presentations
| Study name | HR of recurrence (I versus C) | ORR (I versus C) | HR of progression (I versus C) | HR of death (I versus C) | QoL (I versus C) | % Serious TRAE (I versus C) | % TR deaths (I versus C) | ESMO-MCBS grading |
|---|---|---|---|---|---|---|---|---|
| TROPICS02 | NA | 21% versus 14% | 0.66 (CI 0.53-0.83) | 0.79 (CI 0.65-0.96) | Improved | 74% versus 60% | 2% versus 0% | 2 |
| MonarcHER | NA | NR | AT 0.94 (CI 0.64-1.38) AT + F 0.67 (CI 0.45-1.00) |
AT 0.84 (CI 0.57-1.23) AT + F 0.71 (CI 0.48-1.05) |
Equal | AT 56% versus AT + F 76% versus 54% | NR | 1 |
| CodeBreak200 | NA | 28.1% versus 13.2% | 0.66 (CI 0.51-0.86) | 1.01 (CI 0.77-1.33) | Improved | 40.4% versus 33.1% | 0.3% versus 0.6% | 2 |
| IPSOS | NA | 16.9% versus 7.9% | 0.87 (CI 0.70-1.07) | 0.78 (CI 0.63-0.97) | Equal | 16.3% versus 33.3% | 1% versus 2.7% | 2 |
| COSMIC313 | NA | 40.3% versus 36% | 0.73 (CI 0.57-0.94) | NR | NP | 73% versus 41% | 1% versus 1% | 1 |
| CheckMate 914 | 0.92 (CI 0.71-1.19) | NA | NA | NR | NP | 28% versus 2% | NR | 1 |
| HR-IRI-APC | NA | 13% versus 0.7% | 0.36 (CI 0.27-0.48) | 0.63 (CI 0.48-0.84) | NP | 53.1% versus 43.1% | NR | 3 |
| NICHE2 | NR | NA | NA | NR | NP | 3% versus 0% | NR | NA |
| 309/KEYNOTE-775 | NA | 33.8% versus 14.7% | 0.56 (CI 0.48-0.66) | 0.65 (CI 0.55-0.77) | Improved | 78.8% versus 60.1% | 1.5% versus 2.3% | 4 |
| SOLO/GOG-3004 | NA | NA | 0.33 (CI 0.25-0.43) | 0.55 (CI 0.40-0.76) | NP | 39.6% versus 20% | NR | 4 |
| DeFi | NA | 41% versus 8% | 0.29 (CI 0.15-0.55) | NP | Improved | 57% versus 17% | 0% versus 0.8% | 5 |
| TILs in melanoma | NA | 48.8% versus 21.4% | 0.50 (CI 0.35-0.72) | 0.89 (CI 0.54-1.27) | Unclear | 100% versus 57.3% | NR | 4 |
AT, abemaciclib + trastuzumab; C, comparator arm; CI, 95% confidence interval; DFS, disease-free survival; ESMO-MCBS, European Society for Medical Oncology-Magnitude of Clinical Benefit Scale; F, fulvestrant; HR, hazard ratio; I, intervention arm; NA, not applicable; NP, not performed; NR, not reported; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; QoL, quality of life; serious TRAE, treatment-related adverse event graded 3 or higher; TR, treatment-related.