Lenalidomide clinical study results in lymphoma
| Series/Author . | Year . | No. patients . | Arms . | Conclusions† . |
|---|---|---|---|---|
| Mantle cell: untreated | ||||
| Phase 1/2 | ||||
| Jerkeman et al23 * | 2011 | 12 | BR + lenalidomide (dose escalated) induction; len maint 10-15 mg, d 1-21 × 5 mo | Lenalidomide MTD 10 mg d 1-14; (cycle 1 tox: allergic/cutaneous), ORR 100%, CR 90% |
| 2-y PFS 74%, 2-y OS 87% | ||||
| Ruan et al24 * | 2013 | 38 | Lenalidomide (20 mg d 1-21 q 28 d) + rituximab; len maint 10 mg, d 1-21 until PD | ORR 84%, 53% CR |
| DOR: NR; 2-y PFS 84% | ||||
| Mantle cell: relapsed/refractory | ||||
| Phase 1/2 | ||||
| Wang et al25 | 2012 | 52 | Lenalidomide (dose escalated) + rituximab | Lenalidomide MTD 20 mg, ORR 57%, CR 36%, |
| DOR 19 mo, PFS 11mo, OS 24 mo | ||||
| Phase 2 | ||||
| Habermann et al26 | 2009 | 15 | Lenalidomide (25 mg d 1-21 q 28 d) | ORR 53%, CR 20% |
| DOR 13.7 mo, PFS 5.6 mo | ||||
| Witzig et al27 (NHL-003) | 2011 | 57 | Lenalidomide (25 mg d 1-21 q 28 d) | ORR 42%, CR 21% |
| DOR: NR, PFS 5.7 mo | ||||
| Zaja et al28 | 2012 | 33 | Lenalidomide (25 mg d 1-21 q 28 d) + dexamethasone | ORR 52%, CR 24% |
| DOR 18 mo, PFS 12 mo, OS 20 mo | ||||
| Eve et al29 | 2012 | 26 | Lenalidomide (25 mg d 1-21 q 28 d) × 6 cycle; then len maint | ORR 31%, CR 8% |
| DOR 22 mo, PFS 3.9 mo; maint len PFS 14.6 mo | ||||
| Goy et al30 (MCL-001) | 2013 | 134 | Lenalidomide (25 mg d 1-21 q 28 d) (all pts pretreated with bortezomib) | ORR 28%, CR 8%, |
| DOR 17 mo, PFS 4 mo, OS 19 mo | ||||
| Indolent NHL: untreated | ||||
| Phase 2 | ||||
| Fowler et al31 | 2014 | 50 FL, 30 MZL, 30 SLL | Lenalidomide (20 mg d 1-21 q 28 d) + rituximab | ORR 98%, PFS 89% |
| Indolent NHL: relapsed/refractory | ||||
| Phase 2 | ||||
| Witzig et al (NHL-001)32 | 2009 | 22 | Lenalidomide (20 mg d 1-21 q 28 d) | ORR 27% |
| DOR: NR (>17 mo), PFS 4.4 mo | ||||
| Tuscano et al33 | 2014 | 22 FL | Lenalidomide (20 mg d 1-21 q 28 d) + rituximab | ORR 77% |
| PFS (all) 12.4 mo | ||||
| Chong et al34 | 2015 | 30 FL, 14 MCL, | Lenalidomide 10 mg daily (× five 28-d cycles) and 4 wk rituximab (cycle 3) | ORR with len: 30%; after len + ritux: 63% |
| 4 SLL, 2 MZL (all rituximab-refractory) | DOR len + ritux: 25 mo, PFS 22 mo | |||
| Aggressive B-cell NHL: untreated | ||||
| Phase 2 | ||||
| Reddy et al35 * | 2013 | 43 DLBCL | Maint lenalidomide (25 mg d 1-21) vs lenalidomide (20 mg d 1-21) + rituximab | len vs len + ritux: |
| 2-y PFS: 90% vs 86% | ||||
| 2-y OS: 95% vs 81% | ||||
| Vitolo et al36 (REAL-07) | 2014 | 45 DLBCL | Lenalidomide (15 mg d 1-14) + R-CHOP | CR 86%, PR 6% |
| 2-y PFS 80% | ||||
| 2-y OS 92% | ||||
| Nowakowski et al37 | 2014 | 60 DLBCL | Lenalidomide (25 mg d 1-10) + R-CHOP | ORR 98%, CR 80%, |
| EFS 59% OS 78% | ||||
| Aggressive B-cell NHL: relapsed/refractory | ||||
| Phase1/2 | ||||
| Feldman et al38 | 2014 | 16 DLBCL | Lenalidomide (dose escalation) + RICE; then maint len 25 mg d 1-21 q 28 d × 12 mo | MTD: 25mg d1-4 q 14 d |
| ORR 73%, CR 60% | ||||
| Phase 2 | ||||
| Wiernick et al39 (NHL-002) | 2008 | 5 FLG3, 26 | Lenalidomide (25 mg d 1-21 q 28 d) | ORR: FL 60%, DLBCL, 19% TL 33% |
| DLBCL, 3 TL | PFS (all) 4 mo | |||
| Hernandez et al40 | 2011 | DLBCL 23 | Lenalidomide (25 mg d 1-21 q 28 d) | ORR: Non-GCB: 53%, GCB 9% |
| GCB, 17 | PFS 6.2 mo vs 1.7 mo OS 14 mo vs 13.5 mo | |||
| non-GCB | ||||
| Witzig et al27 (NHL-003) | 2011 | 19 FLG3, | Lenalidomide (25 mg d 1-21 q 28 d) | ORR: FL 42%, DLBCL 28%, TL 45% |
| 108 DLBCL, | PFS: FL 8.9 mo, DLBCL 2.7 mo, TL 5.4 mo | |||
| 33 TL | ||||
| Zinzani et al41 | 2013 | 23 DLBCL | Lenalidomide (20 mg d 1-21 q 28 d) + rituximab | ORR 35% |
| DOR 32 mo | ||||
| Wang et al42 | 2013 | 4 FLG3, 32 | Lenalidomide (20 mg d 1-21 q 28 d) + rituximab | ORR: FL 25%, DLBCL 28%, TL 56% DLBCL: PFS 2.8 mo, OS 10.2 mo, TL: PFS 4.3 mo, OS 11.5 mo |
| DLBCL, 9 TL | ||||
| Aggressive T-cell NHL: relapsed/refractory | ||||
| Phase 2 | ||||
| Zinzani et al43 | 2011 | 10 PTCL NOS | Lenalidomide (25 mg d 1-21 q 28 d) | ORR 30% |
| Morschhauser et al44 (EXPECT) | 2013 | 54 PTCL | Lenalidomide (25 mg d 1-21 q 28 d) | ORR 22%, |
| DOR 3.6 mo, PFS 2.5 mo (4.6 mo in AITL) | ||||
| Querfeld et al45 | 2013 | 32 MF/Sézary | Initially lenalidomide 25 mg d 1-21; amended to 10 mg with incremental (5 mg) dose escalation | ORR 28%, |
| DOR 10 mo, PFS 8 mo, OS 43 mo | ||||
| Toumishey et al46 | 2014 | 40 TCL | Lenalidomide (25 mg d 1-21 q 28 d) | Rel/ref PTCL: ORR 24%, |
| DOR 5 mo, PFS 4 mo, OS 12 mo | ||||
| Untreated PTCL: ORR 50%, | ||||
| DOR 21 mo, PFS 4 mo, OS 12 mo | ||||
| Series/Author . | Year . | No. patients . | Arms . | Conclusions† . |
|---|---|---|---|---|
| Mantle cell: untreated | ||||
| Phase 1/2 | ||||
| Jerkeman et al23 * | 2011 | 12 | BR + lenalidomide (dose escalated) induction; len maint 10-15 mg, d 1-21 × 5 mo | Lenalidomide MTD 10 mg d 1-14; (cycle 1 tox: allergic/cutaneous), ORR 100%, CR 90% |
| 2-y PFS 74%, 2-y OS 87% | ||||
| Ruan et al24 * | 2013 | 38 | Lenalidomide (20 mg d 1-21 q 28 d) + rituximab; len maint 10 mg, d 1-21 until PD | ORR 84%, 53% CR |
| DOR: NR; 2-y PFS 84% | ||||
| Mantle cell: relapsed/refractory | ||||
| Phase 1/2 | ||||
| Wang et al25 | 2012 | 52 | Lenalidomide (dose escalated) + rituximab | Lenalidomide MTD 20 mg, ORR 57%, CR 36%, |
| DOR 19 mo, PFS 11mo, OS 24 mo | ||||
| Phase 2 | ||||
| Habermann et al26 | 2009 | 15 | Lenalidomide (25 mg d 1-21 q 28 d) | ORR 53%, CR 20% |
| DOR 13.7 mo, PFS 5.6 mo | ||||
| Witzig et al27 (NHL-003) | 2011 | 57 | Lenalidomide (25 mg d 1-21 q 28 d) | ORR 42%, CR 21% |
| DOR: NR, PFS 5.7 mo | ||||
| Zaja et al28 | 2012 | 33 | Lenalidomide (25 mg d 1-21 q 28 d) + dexamethasone | ORR 52%, CR 24% |
| DOR 18 mo, PFS 12 mo, OS 20 mo | ||||
| Eve et al29 | 2012 | 26 | Lenalidomide (25 mg d 1-21 q 28 d) × 6 cycle; then len maint | ORR 31%, CR 8% |
| DOR 22 mo, PFS 3.9 mo; maint len PFS 14.6 mo | ||||
| Goy et al30 (MCL-001) | 2013 | 134 | Lenalidomide (25 mg d 1-21 q 28 d) (all pts pretreated with bortezomib) | ORR 28%, CR 8%, |
| DOR 17 mo, PFS 4 mo, OS 19 mo | ||||
| Indolent NHL: untreated | ||||
| Phase 2 | ||||
| Fowler et al31 | 2014 | 50 FL, 30 MZL, 30 SLL | Lenalidomide (20 mg d 1-21 q 28 d) + rituximab | ORR 98%, PFS 89% |
| Indolent NHL: relapsed/refractory | ||||
| Phase 2 | ||||
| Witzig et al (NHL-001)32 | 2009 | 22 | Lenalidomide (20 mg d 1-21 q 28 d) | ORR 27% |
| DOR: NR (>17 mo), PFS 4.4 mo | ||||
| Tuscano et al33 | 2014 | 22 FL | Lenalidomide (20 mg d 1-21 q 28 d) + rituximab | ORR 77% |
| PFS (all) 12.4 mo | ||||
| Chong et al34 | 2015 | 30 FL, 14 MCL, | Lenalidomide 10 mg daily (× five 28-d cycles) and 4 wk rituximab (cycle 3) | ORR with len: 30%; after len + ritux: 63% |
| 4 SLL, 2 MZL (all rituximab-refractory) | DOR len + ritux: 25 mo, PFS 22 mo | |||
| Aggressive B-cell NHL: untreated | ||||
| Phase 2 | ||||
| Reddy et al35 * | 2013 | 43 DLBCL | Maint lenalidomide (25 mg d 1-21) vs lenalidomide (20 mg d 1-21) + rituximab | len vs len + ritux: |
| 2-y PFS: 90% vs 86% | ||||
| 2-y OS: 95% vs 81% | ||||
| Vitolo et al36 (REAL-07) | 2014 | 45 DLBCL | Lenalidomide (15 mg d 1-14) + R-CHOP | CR 86%, PR 6% |
| 2-y PFS 80% | ||||
| 2-y OS 92% | ||||
| Nowakowski et al37 | 2014 | 60 DLBCL | Lenalidomide (25 mg d 1-10) + R-CHOP | ORR 98%, CR 80%, |
| EFS 59% OS 78% | ||||
| Aggressive B-cell NHL: relapsed/refractory | ||||
| Phase1/2 | ||||
| Feldman et al38 | 2014 | 16 DLBCL | Lenalidomide (dose escalation) + RICE; then maint len 25 mg d 1-21 q 28 d × 12 mo | MTD: 25mg d1-4 q 14 d |
| ORR 73%, CR 60% | ||||
| Phase 2 | ||||
| Wiernick et al39 (NHL-002) | 2008 | 5 FLG3, 26 | Lenalidomide (25 mg d 1-21 q 28 d) | ORR: FL 60%, DLBCL, 19% TL 33% |
| DLBCL, 3 TL | PFS (all) 4 mo | |||
| Hernandez et al40 | 2011 | DLBCL 23 | Lenalidomide (25 mg d 1-21 q 28 d) | ORR: Non-GCB: 53%, GCB 9% |
| GCB, 17 | PFS 6.2 mo vs 1.7 mo OS 14 mo vs 13.5 mo | |||
| non-GCB | ||||
| Witzig et al27 (NHL-003) | 2011 | 19 FLG3, | Lenalidomide (25 mg d 1-21 q 28 d) | ORR: FL 42%, DLBCL 28%, TL 45% |
| 108 DLBCL, | PFS: FL 8.9 mo, DLBCL 2.7 mo, TL 5.4 mo | |||
| 33 TL | ||||
| Zinzani et al41 | 2013 | 23 DLBCL | Lenalidomide (20 mg d 1-21 q 28 d) + rituximab | ORR 35% |
| DOR 32 mo | ||||
| Wang et al42 | 2013 | 4 FLG3, 32 | Lenalidomide (20 mg d 1-21 q 28 d) + rituximab | ORR: FL 25%, DLBCL 28%, TL 56% DLBCL: PFS 2.8 mo, OS 10.2 mo, TL: PFS 4.3 mo, OS 11.5 mo |
| DLBCL, 9 TL | ||||
| Aggressive T-cell NHL: relapsed/refractory | ||||
| Phase 2 | ||||
| Zinzani et al43 | 2011 | 10 PTCL NOS | Lenalidomide (25 mg d 1-21 q 28 d) | ORR 30% |
| Morschhauser et al44 (EXPECT) | 2013 | 54 PTCL | Lenalidomide (25 mg d 1-21 q 28 d) | ORR 22%, |
| DOR 3.6 mo, PFS 2.5 mo (4.6 mo in AITL) | ||||
| Querfeld et al45 | 2013 | 32 MF/Sézary | Initially lenalidomide 25 mg d 1-21; amended to 10 mg with incremental (5 mg) dose escalation | ORR 28%, |
| DOR 10 mo, PFS 8 mo, OS 43 mo | ||||
| Toumishey et al46 | 2014 | 40 TCL | Lenalidomide (25 mg d 1-21 q 28 d) | Rel/ref PTCL: ORR 24%, |
| DOR 5 mo, PFS 4 mo, OS 12 mo | ||||
| Untreated PTCL: ORR 50%, | ||||
| DOR 21 mo, PFS 4 mo, OS 12 mo | ||||
AITL, angioimmunoblastic T-cell lymphoma; autoSCT, autologous stem cell transplantation; CHOP, cyclophosphamide, doxorubicin, oncovin, and prednisone; CR, complete remission; d, days; DLBCL, diffuse large B-cell lymphoma; FL, follicular lymphoma; FLG3, follicular lymphoma grade 3; GCB, germinal center B-cell; ICE, ifosfamide carboplatin, etoposide; Len, lenalidomide; maint, maintenance; MF, mycoses fungoides; mo, months; MZL, marginal zone lymphoma; NR, not reached; ORR, overall response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial remission; PTCL NOS, peripheral T-cell lymphoma not otherwise specified; pts, patients; R, rituximab; rel/ref: relapsd/refractory; SLL, small lymphocytic lymphoma; TCL, T-cell lymphoma; TL, transformed lymphoma; yr, year.
Indicates abstract data.
All survival times are medians, unless otherwise specified.