Published phase 2 or 3 data in other hematologic malignancies
| Disease phase (n) . | Regimen (dose) . | Comparator . | Efficacy* . | Safety . | Comment . |
|---|---|---|---|---|---|
| Relapsed multiple myeloma | |||||
| Phase 399 (n = 291) | Ven-BortD 800 mg daily | Pbo-BortD | Median PFS: 22m vs 11m; HR 0.63 (0·44–0·90) | ↑ Neutropenia; ↑ Mortality related to infection | ↑ Efficacy without excess mortality in t(11;14) subgroup |
| Relapsed follicular lymphoma | |||||
| Phase 2141 (n = 163) | Ven-R; Ven-BR 800 mg daily | BR | CMR/CR rate VR: 17% VBR: 75% BR: 69% | ↑ Toxicity with VBR; and ↓ BR dose intensity when combined with Ven | No benefit from adding Ven to BR |
| First-line diffuse large B-cell lymphoma | |||||
| Phase 2142 (N = 206) | Ven-R-CHOP 800 mg 10d | R-CHOP† | CR rate: 69% vs 63%; NS 2-y PFS: 80% vs 67%; HR 0.61 (0.43-0.87) | ↑ Grade 3/4 AEs (86% vs 66%), principally neutropenia | Scheduling needs optimization; ↑ Incremental efficacy if BCL2 IHC+Ven (exploratory) |
| Relapsed mantle-cell lymphoma | |||||
| Phase 2143 (n = 24‡) | Ven-Ibr 400 mg daily | Nil | CR at 16 wk 42% CMR rate 71% | 33% G3/4 neutropenia 17% G3/4 tcp | Dose adjustments for either Ven or Ibr common |
| Phase 1/2144 (n = 24) | Obin-Ven-Ibr 400 mg daily§ | Nil | CMR rate 67% | 33% G4 neutropenia 12% G4 tcp | Dose adjustments for either Ven or Ibr common |
| Disease phase (n) . | Regimen (dose) . | Comparator . | Efficacy* . | Safety . | Comment . |
|---|---|---|---|---|---|
| Relapsed multiple myeloma | |||||
| Phase 399 (n = 291) | Ven-BortD 800 mg daily | Pbo-BortD | Median PFS: 22m vs 11m; HR 0.63 (0·44–0·90) | ↑ Neutropenia; ↑ Mortality related to infection | ↑ Efficacy without excess mortality in t(11;14) subgroup |
| Relapsed follicular lymphoma | |||||
| Phase 2141 (n = 163) | Ven-R; Ven-BR 800 mg daily | BR | CMR/CR rate VR: 17% VBR: 75% BR: 69% | ↑ Toxicity with VBR; and ↓ BR dose intensity when combined with Ven | No benefit from adding Ven to BR |
| First-line diffuse large B-cell lymphoma | |||||
| Phase 2142 (N = 206) | Ven-R-CHOP 800 mg 10d | R-CHOP† | CR rate: 69% vs 63%; NS 2-y PFS: 80% vs 67%; HR 0.61 (0.43-0.87) | ↑ Grade 3/4 AEs (86% vs 66%), principally neutropenia | Scheduling needs optimization; ↑ Incremental efficacy if BCL2 IHC+Ven (exploratory) |
| Relapsed mantle-cell lymphoma | |||||
| Phase 2143 (n = 24‡) | Ven-Ibr 400 mg daily | Nil | CR at 16 wk 42% CMR rate 71% | 33% G3/4 neutropenia 17% G3/4 tcp | Dose adjustments for either Ven or Ibr common |
| Phase 1/2144 (n = 24) | Obin-Ven-Ibr 400 mg daily§ | Nil | CMR rate 67% | 33% G4 neutropenia 12% G4 tcp | Dose adjustments for either Ven or Ibr common |
AE, adverse events; B, bendamustine; Bort, bortezomib; CMR, complete metabolic response (no PET evidence of active lymphoma, but may have residual structural abnormalities); D, dexamethasone; G, grade; Ibr, ibrutinib; IHC+, positive immunohistochemistry for BCL2; Obin, obinutuzumab; Pbo, placebo; R, rituximab; tcp, thrombocytopenia; Ven, venetoclax.
Primary end point of the trial.
Indirect comparison with covariate-adjusted controls from GOYA trial.
Includes 1 first-line patient with TP53 aberration.
Six of 24 patients received either 600 or 800 mg daily of venetoclax.