Efficacy of second-line new agents: summary of phase 2 trials
| Agent: Therapeutic class . | Reference . | Dose and administration . | Inclusion criteria . | No. of patients . | No. of prior lines . | RR, % . | CR + VGPR, % . | DOR, mo . | Median PFS, mo . | Median OS, mo . | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Pomalidomide: IMID | 23 | 2 mg/d po + Dex | 1-3 prior lines Len-refract | 60 | 2 | 63 | 33 | NR at 7 mo | 11.6 | NR | |
| 24 | 2 mg/d po + Dex | Len-refract | 34 | 4 | 32 | 9 | 9.1 | 4.8 | 13.9 | ||
| 25 | 2 mg/d po + Dex | Len-refract | 35 | 6 | 25 | 14 | NR at 14 mo | 6.5 | NR | ||
| 4 mg/d po + Dex | Bort-refract | 35 | 6 | 29 | 12 | 3.9 | 3.2 | NR | |||
| 26 | 4 mg/d po + Dex 21/28 d | >1 line | 43 | 5 | 35 | 4 | 6.4 | 5.4 | 14.9 | ||
| 4 mg/d po + Dex 28 d | 76% Len and Bort-refract | 41 | 5 | 34 | 7 | 8.3 | 4.8 | 14.8 | |||
| 27 | 4 mg/d + Dex 21/28 d | 2 or more prior lines | 123 | 5 | 33 | 3% CR | 10.7 | 4.6 | 16.5 | ||
| 4 mg/d, 21/28 d | 62% Len and Bort-refract | 108 | 5 | 18 | 2% CR | 8.3 | 2.7 | 13.6 | |||
| Carfilzomib: PI | 28 | 20/27 mg/m2 | 2 or more prior lines | 266 | 5 | 23.7 | 5.5 | 7.8 | 3.7 | 15.4 | |
| Days 1-2, 8-9, 15-16 | 28-d cycles | 80% Len and Bort-refract | |||||||||
| 29 | 20 mg/m2 IV | 28-d cycles | 1-3 prior lines | 59 | 2 | 42.4 | 17 | 8.2 | |||
| 20 mg/27 mg/m2 | Days l, 2, 8, 9, 15, 16 | Bort-naive | 70 | 2 | 52.2 | 28.4 | NR | ||||
| Ixazomib: PI | 30 | 4 mg/d, days 1, 8, 15 | 28-d cycles | >1 prior line | 35 | 4 | 31 | 22 | 16.7 | 8.4 | 100% at 6 mo |
| 5.5 mg/d, days 1, 8, 15 | 28-d cycles | Not Bort-refract | 35 | 4 | 19 | 31 | 16.3 | 7.8 | 100% at 6 mo | ||
| Daratumumab: Anti-CD38 antibody | 35 | 16 mg/kg IV weekly, 8 wk, twice monthly, 8 doses monthly thereafter | 76% >3 lines | 148 | 5 | 31.1 | 13.5 | 7.6 | 4 | 20.1 | |
| 86.5% PI and IMID refract | |||||||||||
| Agent: Therapeutic class . | Reference . | Dose and administration . | Inclusion criteria . | No. of patients . | No. of prior lines . | RR, % . | CR + VGPR, % . | DOR, mo . | Median PFS, mo . | Median OS, mo . | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Pomalidomide: IMID | 23 | 2 mg/d po + Dex | 1-3 prior lines Len-refract | 60 | 2 | 63 | 33 | NR at 7 mo | 11.6 | NR | |
| 24 | 2 mg/d po + Dex | Len-refract | 34 | 4 | 32 | 9 | 9.1 | 4.8 | 13.9 | ||
| 25 | 2 mg/d po + Dex | Len-refract | 35 | 6 | 25 | 14 | NR at 14 mo | 6.5 | NR | ||
| 4 mg/d po + Dex | Bort-refract | 35 | 6 | 29 | 12 | 3.9 | 3.2 | NR | |||
| 26 | 4 mg/d po + Dex 21/28 d | >1 line | 43 | 5 | 35 | 4 | 6.4 | 5.4 | 14.9 | ||
| 4 mg/d po + Dex 28 d | 76% Len and Bort-refract | 41 | 5 | 34 | 7 | 8.3 | 4.8 | 14.8 | |||
| 27 | 4 mg/d + Dex 21/28 d | 2 or more prior lines | 123 | 5 | 33 | 3% CR | 10.7 | 4.6 | 16.5 | ||
| 4 mg/d, 21/28 d | 62% Len and Bort-refract | 108 | 5 | 18 | 2% CR | 8.3 | 2.7 | 13.6 | |||
| Carfilzomib: PI | 28 | 20/27 mg/m2 | 2 or more prior lines | 266 | 5 | 23.7 | 5.5 | 7.8 | 3.7 | 15.4 | |
| Days 1-2, 8-9, 15-16 | 28-d cycles | 80% Len and Bort-refract | |||||||||
| 29 | 20 mg/m2 IV | 28-d cycles | 1-3 prior lines | 59 | 2 | 42.4 | 17 | 8.2 | |||
| 20 mg/27 mg/m2 | Days l, 2, 8, 9, 15, 16 | Bort-naive | 70 | 2 | 52.2 | 28.4 | NR | ||||
| Ixazomib: PI | 30 | 4 mg/d, days 1, 8, 15 | 28-d cycles | >1 prior line | 35 | 4 | 31 | 22 | 16.7 | 8.4 | 100% at 6 mo |
| 5.5 mg/d, days 1, 8, 15 | 28-d cycles | Not Bort-refract | 35 | 4 | 19 | 31 | 16.3 | 7.8 | 100% at 6 mo | ||
| Daratumumab: Anti-CD38 antibody | 35 | 16 mg/kg IV weekly, 8 wk, twice monthly, 8 doses monthly thereafter | 76% >3 lines | 148 | 5 | 31.1 | 13.5 | 7.6 | 4 | 20.1 | |
| 86.5% PI and IMID refract | |||||||||||
Bort, bortezomib; Dex, dexamethasone; DOR, duration of response; Len, lenalidomide; NR, not reached; po, by mouth; RR, refract refractory; VGPR, very-good-partial response.