Summary of approved BTKis and their activity in WM
| Study . | Patient population . | Agent(s) . | n . | Time to minor/major response . | ORR (%)/MRR (%) . | ≥VGPR rate (%) . | PFS (%) . |
|---|---|---|---|---|---|---|---|
| Pivotal study39 | R/R | Ibrutinib | 63 | 0.9 mo/2.0 mo | 91/79 | 30 | 54 (60 mo) |
| INNOVATE arm C40 | R/R | Ibrutinib | 31 | 1 mo/2 mo | 87/77 | 29 | 40 (60 mo) |
| Phase 241 | TN | Ibrutinib | 30 | 0.9 mo/1.9 mo | 100/87 | 30 | 76 (48 mo) |
| INNOVATE arms A, B42 | TN, R/R | Ibrutinib Rituximab | 150 | 1 mo/3 mo | 92/76 | 31 | 68 (54 mo) |
| Phase 243 | TN, R/R | Zanubrutinib | 77 | N/A/2.8 mo | 96/82 | 45 | 76 (36 mo) |
| ASPEN cohort 1 (MYD88Mut)44 | TN, R/R | Ibrutinib | 99 | 1 mo/2.9 mo | 94/80 | 25 | 85 (42 mo) |
| TN, R/R | Zanubrutinib | 102 | 1 mo/2.8 mo | 95/81 | 36 | 88 (42 mo) | |
| ASPEN cohort 2 (MYD88WT)44 | TN, R/R | Zanubrutinib | 28 | 1 mo/3.0 mo | 78/63 | 27 | 84 (42 mo) |
| Phase 245 | TN, R/R | Acalabrutinib | 106 | 1 mo/N/A | 94/81 | 39 | 84 TN/52 R/R (66 mo) |
| Phase 246 | TN, R/R | Tirabrutinib | 27 | N/A 1.9 (TN) 2.1 (R/R) | 96/93 | 33 | 93 (24 mo) |
| Phase 247,48 | R/R | Pirtobrutinib | 80 | N/A /N/A | 81 and 67 (prior cBTKi) 88 and 88 (cBTKi naïve) | 24 (prior cBTKi) 29 (cBTKi naïve) | 57 (18 mo for prior cBTKi) N/A for cBTKi naïve |
| Study . | Patient population . | Agent(s) . | n . | Time to minor/major response . | ORR (%)/MRR (%) . | ≥VGPR rate (%) . | PFS (%) . |
|---|---|---|---|---|---|---|---|
| Pivotal study39 | R/R | Ibrutinib | 63 | 0.9 mo/2.0 mo | 91/79 | 30 | 54 (60 mo) |
| INNOVATE arm C40 | R/R | Ibrutinib | 31 | 1 mo/2 mo | 87/77 | 29 | 40 (60 mo) |
| Phase 241 | TN | Ibrutinib | 30 | 0.9 mo/1.9 mo | 100/87 | 30 | 76 (48 mo) |
| INNOVATE arms A, B42 | TN, R/R | Ibrutinib Rituximab | 150 | 1 mo/3 mo | 92/76 | 31 | 68 (54 mo) |
| Phase 243 | TN, R/R | Zanubrutinib | 77 | N/A/2.8 mo | 96/82 | 45 | 76 (36 mo) |
| ASPEN cohort 1 (MYD88Mut)44 | TN, R/R | Ibrutinib | 99 | 1 mo/2.9 mo | 94/80 | 25 | 85 (42 mo) |
| TN, R/R | Zanubrutinib | 102 | 1 mo/2.8 mo | 95/81 | 36 | 88 (42 mo) | |
| ASPEN cohort 2 (MYD88WT)44 | TN, R/R | Zanubrutinib | 28 | 1 mo/3.0 mo | 78/63 | 27 | 84 (42 mo) |
| Phase 245 | TN, R/R | Acalabrutinib | 106 | 1 mo/N/A | 94/81 | 39 | 84 TN/52 R/R (66 mo) |
| Phase 246 | TN, R/R | Tirabrutinib | 27 | N/A 1.9 (TN) 2.1 (R/R) | 96/93 | 33 | 93 (24 mo) |
| Phase 247,48 | R/R | Pirtobrutinib | 80 | N/A /N/A | 81 and 67 (prior cBTKi) 88 and 88 (cBTKi naïve) | 24 (prior cBTKi) 29 (cBTKi naïve) | 57 (18 mo for prior cBTKi) N/A for cBTKi naïve |
Listed BTKis are approved for WM and/or other indications in any jurisdiction. Clinicians should consult local regulatory approvals and guidelines for their status and use in WM.
N/A, data not available; R/R, relapsed or refractory; TN, treatment-naïve.