Table 3.
Outcomes Data from Key Trials Supporting Recent and Possible Future Food and Drug Administration Approvals1
| Trial | Agent or Regimen |
PFS | HR for PFS |
ORR | DOR | CR Rate |
Median OS |
|---|---|---|---|---|---|---|---|
| PANORAMA1 | Panobinostat/Bortezomib/dex | 11.99 months* | 0.63 | 235/387 (60.7%)* | 13.14 months* | 42/387 (11%) | 33.64 months |
| Placebo/Bortezomib/dex | 8.08 months | 208/381 (54.6%) | 10.87 months | 22/381 (6%) | 30.39 months | ||
| ASPIRE | Carfilzomib/ Lenalidomide/dex | 26.3 months* | 0.69 | 345/396 (87.1%)* | 28.6 months* | 126/396 (31.8%)* | 73.3% at 24 months* |
| Lenalidomide/dex | 17.6 months | 264/396 (66.7%) | 21.2 months | 37/396 (9.3%) | 65% at 24 months | ||
| SIRIUS | Daratumumab | 3.7 months | N.A. | 31/106 (29.2%) | 7.4 months | 3/106 (2.8%) | 64.8% at 12 months |
| TOURMALINE 1 | Ixazomib/Lenalidomide/dex | 20.6 months* | 0.74 | 282/360 (78%)* | 20.5 months | 42/360 (12%)* | 81 deaths at 23-months |
| Placebo/Lenalidomide/dex | 14.7 months | 259/362 (72%) | 15.0 months | 24/362 (7%) | 90 deaths at 23-months | ||
| ELOQUENT 2 | Elotuzumab/Lenalidomide/dex | 19.4 months* | 0.70 | 252/321 (79%)* | 20.73 months | 14/321 (4%) | 14 deaths |
| Lenalidomide/dex | 14.9 months | 213/325 (66%) | 16.62 months | 24/325 (7%) | 22 deaths | ||
| ENDEAVOR | Carfilzomib/dex | 18.7 months* | 0.53 | 365/464 (76.7%)* | 21.3 months* | 58/464 (13%)* | 75 deaths |
| Bortezomib/dex | 9.4 months | 290/465 (62.3%) | 10.4 months | 29/465 (6%) | 88 deaths | ||
| CASTOR | Daratumumab/Bortezomib/dex | Not reached* | 0.39 | 199/240 (82.9%)* | Not reached* | 46/240 (19.2%) | 29 deaths |
| Bortezomib/dex | 7.2 months | 148/234 (63.2%) | 7.9 months | 21/234 (9.0%) | 36 deaths | ||
| POLLUX | Daratumumab/Lenalidomide/dex | Not reached* | 0.37 | 261/281 (92.9%)* | Not reached* | 121/281 (43.1%)* | 86.1% at 18 months |
| Lenalidomide/dex | 18.4 months | 211/276 (76.4%) | 17.4 months | 53/276 (19.2%) | 75.6% at 18 months* |
1
Abbreviations: CR, complete response; dex, dexamethasone; DOR, duration of response; HR, hazard ratio; N.A.; not applicable; OS, overall survival; ORR, overall response rate, defined as partial response or better; PFS, progression-free survival;
*
Indicates that the value in question is statistically significantly better than the relevant control, where significance is defined by a p value of <0.05