Table 3.
Clinical studies of Panobinostat (LBH589) in relapsed MM
| Phase | Regimen | Schedule | Response | Toxic Effects grade >2 occurring in >10% of patients | References |
|---|---|---|---|---|---|
| II | LBH589 | LBH589 20mg/d | 2% VGPR 2% MR 8% SD |
Anemia 16% Thrombocytopenia 26% Neutropenia 32% Fatigue/Nausea 50% |
Wolf et al, 2008 |
| Ib | LBH589 + BORTEZOMIB | LBH589 Escalating dose up to 20mg orally/tw; BORTEZOMIB 1.3 mg/m2 IV days 1, 4, 8, 11 (21-day cycles) |
76% ≥MR | Anemia 21% Thrombocytopenia 75% Neutropenia 53% Asthenia 16% |
San-Miguel et al, ASCO 2011 |
| III (PANORAMA1) | LBH589 + BORTEZOMIB + DEXAMETHASONE | LBH589 20 mg tw; BORTEZOMIB 1.3 mg/m2 IV, day 1, 4, 8, 11; DEX 20MG day 1,2, 4,5, 8,9, 11,12 (21-day cycle) | ongoing | ongoing | San-Miguel et al, ASCO 2011 |
| II (PANORAMA2) | LBH589 + BORTEZOMIB + DEXAMETHASONE | LBH589 20 mg tw; BORTEZOMIB 1.3 mg/m2 IV, day 1, 4, 8, 11; DEX 20MG day 1,2, 4,5, 8,9, 11,12 (21-day cycle) | Phase 1: 4% nCR 13% PR 13% MR Phase 2: ongoing |
Anemia 10% Thrombocytopenia 38% Neutropenia 12% Pneumonia 10% Peripheral Neuropathy 17% |
Richardson et al, ASH 2011 |
Tw, thrice weekly; CR, complete response; nCR, near complete response, VGPR, very good partial response; PR, partial response; MR, minimal response; SD, stable disease; IV, intravenous;
National Cancer Institute Common Terminology Criteria for Adverse Events