Efficacy outcomes by renal impairment subgroup
| . | CrCL, mL/min . | |||||
|---|---|---|---|---|---|---|
| ≥15 to <50 . | 50 to <80 . | ≥80 . | ||||
| Kd56 (n = 85) . | Vd (n = 99) . | Kd56 (n = 186) . | Vd (n = 177) . | Kd56 (n = 193) . | Vd (n = 189) . | |
| Median PFS, mo* | 14.9 | 6.5 | 18.6 | 9.4 | Not reached | 12.2 |
| HR for Kd56 vs Vd (95% CI) | 0.49 (0.320-0.757) | 0.48 (0.351-0.652) | 0.60 (0.434-0.827) | |||
| Median OS, mo | 42.1 | 23.7 | 42.5 | 32.8 | Not reached | 42.3 |
| HR for Kd56 vs Vd (95% CI) | 0.66 (0.443-0.989) | 0.83 (0.626-1.104) | 0.75 (0.554-1.009) | |||
| ORR, %* | 74.1 | 49.5 | 78.5 | 69.5 | 76.7 | 63.0 |
| Odds ratio (95% CI) | 2.922 (1.564-5.460) | 1.602 (0.997-2.574) | 1.935 (1.239-3.021) | |||
| ≥CR, %* | 8.2 | 4.0 | 9.1 | 7.3 | 17.6 | 6.3 |
| ≥VGPR, %* | 51.8 | 28.3 | 55.4 | 26.0 | 54.4 | 31.2 |
| Median DOR, mo* | 16.6 | 9.3 | 17.6 | 9.3 | Not reached | 14.0 |
| Complete renal response, % | 15.3 | 14.1 | — | — | — | — |
| PFS by prior line of therapy | ||||||
| 1 prior line, n | 39 | 43 | 96 | 85 | 96 | 101 |
| Median PFS, mo | 17.7 | 9.3 | 18.7 | 9.5 | Not reached | 12.1 |
| HR for Kd56 vs Vd (95% CI) | 0.44 (0.212-0.918) | 0.46 (0.288-0.731) | 0.42 (0.251-0.685) | |||
| 2-3 prior lines | 46 | 56 | 90 | 92 | 97 | 88 |
| Median PFS, mo | 11.1 | 6.1 | 15.7 | 7.5 | Not reached | 12.4 |
| HR for Kd56 vs Vd (95% CI) | 0.47 (0.274-0.817) | 0.51 (0.339-0.778) | 0.77 (0.505-1.186) | |||
| OS by prior line of therapy | ||||||
| 1 prior line, n | 39 | 43 | 96 | 85 | 96 | 101 |
| Median OS, mo | 51.3 | 26.5 | 48.8 | 43.2 | Not reached | 44.5 |
| HR for Kd56 vs Vd (95% CI) | 0.53 (0.272-1.029) | 0.88 (0.577-1.353) | 0.77 (0.491-1.203) | |||
| 2-3 prior lines | 46 | 56 | 90 | 92 | 97 | 88 |
| Median OS, mo | 28.6 | 21.7 | 36.1 | 28.2 | Not reached | 32.9 |
| HR for Kd56 vs Vd (95% CI) | 0.79 (0.475-1.298) | 0.81 (0.552-1.186) | 0.70 (0.469-1.059) | |||
| . | CrCL, mL/min . | |||||
|---|---|---|---|---|---|---|
| ≥15 to <50 . | 50 to <80 . | ≥80 . | ||||
| Kd56 (n = 85) . | Vd (n = 99) . | Kd56 (n = 186) . | Vd (n = 177) . | Kd56 (n = 193) . | Vd (n = 189) . | |
| Median PFS, mo* | 14.9 | 6.5 | 18.6 | 9.4 | Not reached | 12.2 |
| HR for Kd56 vs Vd (95% CI) | 0.49 (0.320-0.757) | 0.48 (0.351-0.652) | 0.60 (0.434-0.827) | |||
| Median OS, mo | 42.1 | 23.7 | 42.5 | 32.8 | Not reached | 42.3 |
| HR for Kd56 vs Vd (95% CI) | 0.66 (0.443-0.989) | 0.83 (0.626-1.104) | 0.75 (0.554-1.009) | |||
| ORR, %* | 74.1 | 49.5 | 78.5 | 69.5 | 76.7 | 63.0 |
| Odds ratio (95% CI) | 2.922 (1.564-5.460) | 1.602 (0.997-2.574) | 1.935 (1.239-3.021) | |||
| ≥CR, %* | 8.2 | 4.0 | 9.1 | 7.3 | 17.6 | 6.3 |
| ≥VGPR, %* | 51.8 | 28.3 | 55.4 | 26.0 | 54.4 | 31.2 |
| Median DOR, mo* | 16.6 | 9.3 | 17.6 | 9.3 | Not reached | 14.0 |
| Complete renal response, % | 15.3 | 14.1 | — | — | — | — |
| PFS by prior line of therapy | ||||||
| 1 prior line, n | 39 | 43 | 96 | 85 | 96 | 101 |
| Median PFS, mo | 17.7 | 9.3 | 18.7 | 9.5 | Not reached | 12.1 |
| HR for Kd56 vs Vd (95% CI) | 0.44 (0.212-0.918) | 0.46 (0.288-0.731) | 0.42 (0.251-0.685) | |||
| 2-3 prior lines | 46 | 56 | 90 | 92 | 97 | 88 |
| Median PFS, mo | 11.1 | 6.1 | 15.7 | 7.5 | Not reached | 12.4 |
| HR for Kd56 vs Vd (95% CI) | 0.47 (0.274-0.817) | 0.51 (0.339-0.778) | 0.77 (0.505-1.186) | |||
| OS by prior line of therapy | ||||||
| 1 prior line, n | 39 | 43 | 96 | 85 | 96 | 101 |
| Median OS, mo | 51.3 | 26.5 | 48.8 | 43.2 | Not reached | 44.5 |
| HR for Kd56 vs Vd (95% CI) | 0.53 (0.272-1.029) | 0.88 (0.577-1.353) | 0.77 (0.491-1.203) | |||
| 2-3 prior lines | 46 | 56 | 90 | 92 | 97 | 88 |
| Median OS, mo | 28.6 | 21.7 | 36.1 | 28.2 | Not reached | 32.9 |
| HR for Kd56 vs Vd (95% CI) | 0.79 (0.475-1.298) | 0.81 (0.552-1.186) | 0.70 (0.469-1.059) | |||
CR, complete response; DOR, duration of response; VGPR, very good partial response.
Data are from the primary analysis data cut.