TABLE A2.
Efficacy Comparison of Previous Data Cutoffs in the Treatment-Naïve Population
| Data Cutoff Date | December 16, 2019 | March 30, 2020 | June 15, 2021 | January 13, 2023 |
|---|---|---|---|---|
| No. | 39 | 48 | 69 | 69 |
| ORR by IRC, % (95% CI) | 85 (70 to 94) | 85 (72 to 94) | 84 (73 to 92) | 83 (72 to 91) |
| DoR | ||||
| Patients with censored data, No. (%) | 26 (78.8) | 31 (75.6) | 32 (55.2) | 25 (43.9) |
| DoR, months, median (95% CI) | NE (12.0 to NE) | NE (12.0 to NE) | 20.2 (13.0 to NE) | 20.3 (15.4 to 29.5) |
| Duration of follow-up, months, median | 7.4 | 9.8 | 20.3 | 37.1 |
| 1-year DoR, % (95% CI) | 63.5 (34.0 to 82.6) | 65.0 (42.8 to 80.3) | 66.1 (51.6 to 77.3) | 66.7 (52.4 to 77.6) |
| 2-year DoR, % (95% CI) | NR | NR | 41.6 (25.6 to 56.8) | 38.1 (24.5 to 51.6) |
| 3-year DoR, % (95% CI) | NR | NR | NR | 35.4 (22.0 to 49.0) |
| PFS | ||||
| Patients with censored data, No. (%) | 30 (76.9) | 34 (70.8) | 37 (53.6) | 31 (44.9) |
| PFS, months, median (95% CI) | NE (13.8 to NE) | NE (13.8 to NE) | 22.0 (13.8 to NE) | 22.0 (16.5 to 24.9) |
| Duration of follow-up, months, median | 9.2 | 10.8 | 21.9 | 38.9 |
| 1-year PFS, % (95% CI) | 75 (56 to 87) | 67.6 (49.5 to 80.3) | 70.6 (57.8 to 80.2) | 70.8 (58.0 to 80.3) |
| 2-year PFS, % (95% CI) | NR | NR | 41.6 (26.8 to 55.8) | 44.9 (31.8 to 57.3) |
| 3-year PFS, % (95% CI) | NR | NR | NR | 34.6 (22.3 to 47.3) |
Abbreviations: DoR, duration of response; IRC, independent review committee; NE, not estimable; NR, not reached; ORR, objective response rate; PFS, progression-free survival.