Table 1.
Ongoing or planned studies with belantamab mafodotin (belamaf).
| Study | Phase | Treatment | Patient population | Results |
|---|---|---|---|---|
| DREAMM-1 (NCT02064387)14,15 | I | Single-agent belamaf Dose escalation Dose expansion at RP2D (3.4 mg/kg Q3W) |
RRMM with ⩾2 lines of therapy including PI, IMiD, and alkylator agent | 3.4 mg/kg dose (n = 35) ORR 60% DOR: 14.3 mo PFS: 12 mo ORR: 38.5% in triple-class refractory patients (n = 13) |
| DREAMM-2 (NCT03525678)17 | II | Belamaf 2.5 mg/kg Q3W Belamaf 3.4 mg/kg Q3W |
RRMM with ⩾3 lines of therapy and refractory to PI and IMiD, and refractory to and/or intolerant to anti-CD38 mAb | 2.5 mg/kg (n = 97) ORR: 31% PFS: 2.9 mo DOR: 11 mo OS: 13.7 mo 3.4 mg/kg (n = 99) ORR: 34% PFS: 3.9 mo DOR: 6.2 mo OS: 13.8 mo |
| DREAMM-3 (NCT04162210) | III | Belamaf versus Pomalidomide and dexamethasone |
RRMM with ⩾2 lines of therapy including PI and lenalidomide | pending |
| DREAMM-4 (NCT03848845) | I/II | Belamaf + Pembrolizumab | RRMM with ⩾3 lines of therapy including PI, IMiD, and anti-CD38 mAb | pending |
| DREAMM-5 (NCT04126200) | I/II | Belamaf in combination with: Substudy 1: GSK3174998 (anti-OX-40 monoclonal antibody) Substudy 2: GSK3359609 (anti-ICOS agonist) Substudy 3: nirogacestat (small molecule gamma secretase inhibitor) Substudy 4: dostarlimab (anti-PD-1 monoclonal antibody) |
RRMM with ⩾3 lines of therapy including PI, IMiD, and anti-CD38 mAb | pending |
| DREAMM-6 (NCT03544281)19 | I/II | Belamaf (Q3W or split D1 and D8 dose Q3W) in combination with: Arm A: Lenalidomide and dexamethasone Arm B: Bortezomib and dexamethasone |
RRMM ⩾1 line of therapy | Arm A: pending Arm B: ORR 78% and ⩾VGPR 50% (preliminary) |
| DREAMM-7 (NCT04246047) | III | Belamaf + bortezomib, dexamethasone versus Daratumumab + bortezomib, dexamethasone |
RRMM ⩾1 line of therapy | pending |
| DREAMM-8 (NCT04484623) | III | Belamaf + pomalidomide and dexamethasone versus Bortezomib + pomalidomide and dexamethasone |
RRMM ⩾1 line of therapy including lenalidomide | pending |
| DREAMM-9 (NCT04091126) |
I | Belamaf (multiple dose cohorts) -1.9 mg/kg Q3/4W -1.4 mg/kg Q6/8W -1.9 mg/kg Q6/8W -1.0 mg/kg Q3/4W -1.4 mg/kg Q3/4W -1.9 or 2.5 mg/kg Q9/12W -1.9/2.5 mg/kg Q6/8W (split) -2.5 mg/kg Q6/8W in combination with: bortezomib, lenalidomide, dexamethasone × 8 cycles followed by lenalidomide and dexamethasone |
Transplant ineligible NDMM | pending |
| DREAMM-12 (NCT04398745) |
I | Belamaf | Renal Impairment RRMM with ⩾2 lines of therapy including PI and IMiD |
pending |
| DREAMM-13 (NCT04398680) |
I | Belamaf | Hepatic Impairment RRMM with ⩾2 lines of therapy including PI and IMiD |
pending |
| ALGONQUIN (NCT03715478) |
I/II | Belamaf (Q4W or split D1 and D8 dose Q4W) in combination with: pomalidomide and dexamethasone |
RRMM with ⩾2 lines of therapy including PI and lenalidomide | pending |
D, day; DOR, duration of response; IMiD, immunomodulatory drug; mAb, monoclonal antibody; mo, month; n, number; NDMM, newly diagnosed multiple myeloma; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PI, proteasome inhibitor; Q, every; RP2D, recommended phase II dose; RRMM, relapsed and/or refractory multiple myeloma; W, week.