Results of phase 3 randomized studies which evaluated regimens for patient with 1 to 3 prior lines of therapy
. | Dara-Rd . | Rd . | K-Rd . | Rd . | Elo-Rd . | Rd . | Ixa-Rd . | Rd . | Kd . | Vd . | Dara-Vd . | Vd . | Dara-Kd . | Kd . | Isa-Kd . | Kd . | SVd . | Vd . | Ven-Vd . | Vd . |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Median of prior lines of therapy in the study (range) | 1 (1-11) | 2 (1-3) | 2 (1-4) | 1 (1-3) | 2 (1-3) | 2 (1-10) | 2 (1-3) | 1 (1-3) | 1 (1-3) | 2 (1-3) | ||||||||||
Exclusion per prior therapy | Lenalidomide- resistant | Lenalidomide- resistant and bortezomib- resistant if at last line | Lenalidomide- resistant | Lenalidomide- or bortezomib- resistant | Bortezomib- resistant | Bortezomib- resistant | previous resistance to carfilzomib, or refractory to anti-CD38 | previous treatment with carfilzomib, or refractory to anti-CD38 | Bortezomib- resistant | Bortezomib- resistant | ||||||||||
ITT population | 283 | 286 | 396 | 396 | 321 | 325 | 360 | 362 | 464 | 465 | 251 | 247 | 312 | 154 | 179 | 123 | 195 | 207 | 194 | 97 |
PFS | 46 | 17.5 | 26.3 | 17.6 | 19.4 | 14.9 | 20.6 | 14.7 | 18.7 | 9.4 | 16.7 | 7.1 | NE | 15.8 | NE | 19.1 | 13.9 | 9.4 | 22.4 | 11.5 |
HR (95% CI) | 0.42 (0.33-0.52) | 0.69 (0.57-0.83) | 0.71 (0.59-0.86) | 0.74 (0.59-0.94) | 0.53 (0.44-0.65) | 0.31 (0.25-0.39) | 0.63 (0.46-0.85) | 0.53 (0.32-0.89) | 0.70 (0.53-0.93) | 0.63 (0.44-0.90) | ||||||||||
1 prior line | 149 | 146 | 184 | 157 | 151 | 159 | 212 | 213 | 231 | 229 | 247 | 251 | 144 | 70 | 80 | 55 | 99 | 99 | 91 | 44 |
PFS | 53.3 | 19.6 | 29.6 | 17.6 | NA | NA | 20.6 | 16.6 | 22.2 | 10.1 | 27 | 7.9 | NA | NA | 22.4 | 11.4 | ||||
HR | 0.42 (0.30-0.57) | 0.713 (0.532-0.957 | 0.77 (0.59-1.01) | 0.882 (0.65-1.197) | 0.447 (0.330-0.606) | 0.22 (0.15-0.32) | 0.68 (0.40-1.14) | 0.589 (0.309-1.123) | 0.63 (0.41-0.96) | 0.75 (0.45-1.26) | ||||||||||
2-3 prior lines | 123 | 118 | 212 | 239 | 170 | 166 | 148 | 149 | 232 | 233 | 106 | 107 | 179 | 87 | 99 | 68 | 96 | 108 | 103 | 53 |
PFS | NA | NA | 25.8 | 16.7 | NA | NA | NE | 12.9 | 14.9 | 8.4 | NA | NA | NA | NA | NA | NA | NA | NA | NE | 14 |
HR (95% CI) | 2 prior lines: 0.39 (0.26-0.58) | 0.720 (0.561-0.923) | 0.68 (0.53-0.87) | 0.58 (0.401-0.838) | 0.604 (0.466-0.783) | 2 prior lines: 0.46 (0.30-0.72) | 0.61 (0.42-0.88) | 0.479 (0.294-0.778) | 2 prior lines: 0.65 (0.40-1.07) | 0.54 (0.33-0.88) | ||||||||||
3 prior lines: 0.48 (0.25-0.94) | 3 prior lines: 0.60 (0.33-1.07) |
. | Dara-Rd . | Rd . | K-Rd . | Rd . | Elo-Rd . | Rd . | Ixa-Rd . | Rd . | Kd . | Vd . | Dara-Vd . | Vd . | Dara-Kd . | Kd . | Isa-Kd . | Kd . | SVd . | Vd . | Ven-Vd . | Vd . |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Median of prior lines of therapy in the study (range) | 1 (1-11) | 2 (1-3) | 2 (1-4) | 1 (1-3) | 2 (1-3) | 2 (1-10) | 2 (1-3) | 1 (1-3) | 1 (1-3) | 2 (1-3) | ||||||||||
Exclusion per prior therapy | Lenalidomide- resistant | Lenalidomide- resistant and bortezomib- resistant if at last line | Lenalidomide- resistant | Lenalidomide- or bortezomib- resistant | Bortezomib- resistant | Bortezomib- resistant | previous resistance to carfilzomib, or refractory to anti-CD38 | previous treatment with carfilzomib, or refractory to anti-CD38 | Bortezomib- resistant | Bortezomib- resistant | ||||||||||
ITT population | 283 | 286 | 396 | 396 | 321 | 325 | 360 | 362 | 464 | 465 | 251 | 247 | 312 | 154 | 179 | 123 | 195 | 207 | 194 | 97 |
PFS | 46 | 17.5 | 26.3 | 17.6 | 19.4 | 14.9 | 20.6 | 14.7 | 18.7 | 9.4 | 16.7 | 7.1 | NE | 15.8 | NE | 19.1 | 13.9 | 9.4 | 22.4 | 11.5 |
HR (95% CI) | 0.42 (0.33-0.52) | 0.69 (0.57-0.83) | 0.71 (0.59-0.86) | 0.74 (0.59-0.94) | 0.53 (0.44-0.65) | 0.31 (0.25-0.39) | 0.63 (0.46-0.85) | 0.53 (0.32-0.89) | 0.70 (0.53-0.93) | 0.63 (0.44-0.90) | ||||||||||
1 prior line | 149 | 146 | 184 | 157 | 151 | 159 | 212 | 213 | 231 | 229 | 247 | 251 | 144 | 70 | 80 | 55 | 99 | 99 | 91 | 44 |
PFS | 53.3 | 19.6 | 29.6 | 17.6 | NA | NA | 20.6 | 16.6 | 22.2 | 10.1 | 27 | 7.9 | NA | NA | 22.4 | 11.4 | ||||
HR | 0.42 (0.30-0.57) | 0.713 (0.532-0.957 | 0.77 (0.59-1.01) | 0.882 (0.65-1.197) | 0.447 (0.330-0.606) | 0.22 (0.15-0.32) | 0.68 (0.40-1.14) | 0.589 (0.309-1.123) | 0.63 (0.41-0.96) | 0.75 (0.45-1.26) | ||||||||||
2-3 prior lines | 123 | 118 | 212 | 239 | 170 | 166 | 148 | 149 | 232 | 233 | 106 | 107 | 179 | 87 | 99 | 68 | 96 | 108 | 103 | 53 |
PFS | NA | NA | 25.8 | 16.7 | NA | NA | NE | 12.9 | 14.9 | 8.4 | NA | NA | NA | NA | NA | NA | NA | NA | NE | 14 |
HR (95% CI) | 2 prior lines: 0.39 (0.26-0.58) | 0.720 (0.561-0.923) | 0.68 (0.53-0.87) | 0.58 (0.401-0.838) | 0.604 (0.466-0.783) | 2 prior lines: 0.46 (0.30-0.72) | 0.61 (0.42-0.88) | 0.479 (0.294-0.778) | 2 prior lines: 0.65 (0.40-1.07) | 0.54 (0.33-0.88) | ||||||||||
3 prior lines: 0.48 (0.25-0.94) | 3 prior lines: 0.60 (0.33-1.07) |
The results according to the number of prior lines of therapy are also reported where available.
NA, not available; NE, not estimable/not reached.