Regimens for patients with lenalidomide-refractory disease
| . | Regimen . | Median prior lines of therapy . | Len-refractory n (% of total study population) . | mPFS for all population . | mPFS for first relapse . | mPFS, mo for len refractory . | PFS HR for len refractory . | mPFS, months for len refractory at first relapse or HR . | Approved therapy . |
|---|---|---|---|---|---|---|---|---|---|
| CASTOR | Dara-Vd | 2 (1-10) | 60 (24) | 16.7 | 27 | 7.8 | 0.44 | NR | YES after at least 1 prior line |
| Vd | 81 (33) | 7.1 | 7.9 | 4.9 | NR | ||||
| CANDOR | Dara-Kd56 | 2 (1-3) | 99 (32) | NE | NE (HR, 0.68) | NE | 0.474 | HR, 0.11 (0.02-0.52) | YES (FDA: after 1-3 prior lines; Dara-Kd56 & Dara-Kd70; EMA: after 1 prior line only Dara-Kd56) |
| Kd56 | 55 (36) | 15.8 | 11.1 | ||||||
| IKEMA | Isa-Kd56 | 2 (1-3) | 57 (32) | NE | NE (HR, 0.59) | NE | 0.60 (0.34-1.06) | HR, 0.69 for refractory to len at last line | YES (FDA: after 1-3 prior lines; EMA: after 1 prior line) |
| Kd56 | 42 (34) | 19.15 | 15.7 | ||||||
| APOLLO | Dara-Pd | 2 (1-5) | 120 (79) | 12.4 | 14.1 | 9.9 | 0.66 | NR | YES |
| Pd | 122 (80) | 6.9 | 12.6 | 6.5 | NR | ||||
| ICARIA | Isa-Pd | 3 (2-11) | 144 (94) | 11.5 | − | 11.4 | 0.59 | 11.6 vs 5.7 if Len-refractory at last line (HR, 0.50) | YES (after >2 lines of therapy) |
| Pd | 140 (92) | 6.5 | − | 5.59 | |||||
| ELOQUENT-3 | Elo-Pd | 3 (2-8) | 59 (98) | 10.3 | − | NR | NR | NR | YES (after >2 lines of therapy) |
| Pd | 55 (96) | 4.7 | − | NR | NR | NR | |||
| ENDEAVOR | Kd | 2 (1-3) | 113 (24) | 18.7 | 22.2 | 8.6 | 0.80 | <18 mo of prior len: 10.8 vs 6.7 mo | YES after at least 1 prior line |
| Vd | 122 (26) | 9.4 | 10.1 | 6.6 | |||||
| OPTIMISMM | Bort-Pd | 2 (1-3) | 200 (71) | 11.2 | 20.7 | NR | 0.65 | 17.6 vs 9.5; HR, 0.55 | YES (EMA: after at least 1 prior line that included lenalidomide) |
| Pd | 191 (69) | 7.1 | 11.6 | NR | |||||
| BOSTON | Sel-Vd | 1 (1-3) | 77 (39) | 13.93 | 16.62 | 9.59 | 0.63 | NR | YES (FDA only: after at least 1 prior line) |
| Vd | 77 (37) | 9.46 | 10.68 | 7.23 | NR | ||||
| BELLINI | Ven-Vd | 1 (1-3) | 38 (20) | 22.4 | 22.4 | NE | 0.75 | NR | NO |
| Vd | 27 (28) | 11.5 | 11.4 | 14.8 | NR |
| . | Regimen . | Median prior lines of therapy . | Len-refractory n (% of total study population) . | mPFS for all population . | mPFS for first relapse . | mPFS, mo for len refractory . | PFS HR for len refractory . | mPFS, months for len refractory at first relapse or HR . | Approved therapy . |
|---|---|---|---|---|---|---|---|---|---|
| CASTOR | Dara-Vd | 2 (1-10) | 60 (24) | 16.7 | 27 | 7.8 | 0.44 | NR | YES after at least 1 prior line |
| Vd | 81 (33) | 7.1 | 7.9 | 4.9 | NR | ||||
| CANDOR | Dara-Kd56 | 2 (1-3) | 99 (32) | NE | NE (HR, 0.68) | NE | 0.474 | HR, 0.11 (0.02-0.52) | YES (FDA: after 1-3 prior lines; Dara-Kd56 & Dara-Kd70; EMA: after 1 prior line only Dara-Kd56) |
| Kd56 | 55 (36) | 15.8 | 11.1 | ||||||
| IKEMA | Isa-Kd56 | 2 (1-3) | 57 (32) | NE | NE (HR, 0.59) | NE | 0.60 (0.34-1.06) | HR, 0.69 for refractory to len at last line | YES (FDA: after 1-3 prior lines; EMA: after 1 prior line) |
| Kd56 | 42 (34) | 19.15 | 15.7 | ||||||
| APOLLO | Dara-Pd | 2 (1-5) | 120 (79) | 12.4 | 14.1 | 9.9 | 0.66 | NR | YES |
| Pd | 122 (80) | 6.9 | 12.6 | 6.5 | NR | ||||
| ICARIA | Isa-Pd | 3 (2-11) | 144 (94) | 11.5 | − | 11.4 | 0.59 | 11.6 vs 5.7 if Len-refractory at last line (HR, 0.50) | YES (after >2 lines of therapy) |
| Pd | 140 (92) | 6.5 | − | 5.59 | |||||
| ELOQUENT-3 | Elo-Pd | 3 (2-8) | 59 (98) | 10.3 | − | NR | NR | NR | YES (after >2 lines of therapy) |
| Pd | 55 (96) | 4.7 | − | NR | NR | NR | |||
| ENDEAVOR | Kd | 2 (1-3) | 113 (24) | 18.7 | 22.2 | 8.6 | 0.80 | <18 mo of prior len: 10.8 vs 6.7 mo | YES after at least 1 prior line |
| Vd | 122 (26) | 9.4 | 10.1 | 6.6 | |||||
| OPTIMISMM | Bort-Pd | 2 (1-3) | 200 (71) | 11.2 | 20.7 | NR | 0.65 | 17.6 vs 9.5; HR, 0.55 | YES (EMA: after at least 1 prior line that included lenalidomide) |
| Pd | 191 (69) | 7.1 | 11.6 | NR | |||||
| BOSTON | Sel-Vd | 1 (1-3) | 77 (39) | 13.93 | 16.62 | 9.59 | 0.63 | NR | YES (FDA only: after at least 1 prior line) |
| Vd | 77 (37) | 9.46 | 10.68 | 7.23 | NR | ||||
| BELLINI | Ven-Vd | 1 (1-3) | 38 (20) | 22.4 | 22.4 | NE | 0.75 | NR | NO |
| Vd | 27 (28) | 11.5 | 11.4 | 14.8 | NR |
EMA, European Medicines Agency; FDA, Food and Drug Administration; NE, not evaluable/not reached; NR, not reported.