Patients type | Treatment regimen | Efficacy | Study | Phase | Patients (N) |
---|---|---|---|---|---|
Patients with treatment naïve MCL | |||||
Indolent clinical forms | Ibrutinib + rituximab | ORR: 84%; CR rate: 80%; estimated PFS at 36 months: 93% | IMCL-2015 [62] | 2 | 50 |
Untreated MCL | Zanubrutinib + rituximab followed by rituximab (375 mg/m2), dexamethasone (20 mg), cytarabine (2000 mg/m2), and oxaliplatin (130 mg/m2) (R-DHAOx) then zanubrutinib maintenance | CR rate: 88.2% (15/17); MRD negative rate: 100% Study ongoing | NCT04624958 [173] | 2 | 17 |
ASCT eligible | Ibrutinib + R-CHOP followed by w/wo ASCT + ibrutinib maintenance | ORR: 98%; CR rate: 45%; 3-year FFS rate: 86% | TRIANGLE [66] | 3 | 807 |
Zanubrutinib + rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2, prednisone 100 mg, (R-CHOP)/ dexamethasone 40 mg, rituximab 375 mg/m2, cytarabine 2 × 2 g/m2, cisplatin 100 mg/m2 (R-DHAOx) ± ASCT | CR: 85.7% (6/7); MRD negative rate: 100% Study ongoing | NCT04736914 [64] | 2 | 47 | |
ASCT ineligible | Ibrutinib + BR vs. placebo + BR | Median PFS: 80.6 vs. 52.9 months; CR rate: 65.5% vs. 65.5% | SHINE [63] | 3 | 523 |
Zanubrutinib + rituximab vs. BR | Ongoing | MANGROVE [65] | 3 | 500 | |
Patients with R/R MCL | |||||
Overall | Zanubrutinib | ORR: 83.7%; CR rate: 77.9%; median PFS: 33 months | BGB-3111–206 [72] | 2 | 86 |
Acalabrutinib | ORR: 81%; CR rate: 40%; 12-month PFS rate: 67%, 12-month; OS rate: 87% | ACE-LY-004 [14] | 2 | 124 | |
Ibrutinib | ORR: 68%; CR rate: 21%; median PFS: 13.9Â months | PCYC-1104 [8] | 2 | 111 | |
Orelabrutinib | ORR: 82.5%; CR rate: 24.7% | ICP-022-MCL [73] | 2 | 97 |