Combination therapy strategy | Disease state(s) | Efficacy | Reference or Clinicaltrials.gov identifier | Phase |
---|---|---|---|---|
Venetoclax + low-dose cytarabine | Previously untreated AML | ORR: 54% Median OS: 10.1 months Median DOR: 8.1 months | Wei et al. NCT02287233 [17] | Ib/2 |
Venetoclax + HAMs (decitabine or azacitidine) | Treatment-naïve AML | ORR: 68% (99/145) Median OS: 17.5 months Median DOR: 11.3 months MRD negative: 29% (28/97) | DiNardo et al. NCT02203773 [16] | Ib |
Venetoclax + ibrutinib | Previously untreated high-risk and elderly CLL | ORR: 88% (29/33) Estimated 1-year PFS: 98% Estimated 1-year OS: 99% BM MRD negative: 61% (20/33) | Jain et al. NCT02756897 [72] | II |
Venetoclax + rituximab | RR CLL | ORR: 86% (42/49) Estimated 2-year PFS: 82% Estimated 2-year OS: 89% BM MRD negative: 80% (20/25) | Seymour et al. NCT01682616 [74] | I |
Venetoclax + rituximab vs bendamustine + rituximab | RR CLL | ORR: 93.3% vs 67.7% CR/CRi: 26.8% vs 8.2% 2-year PFS: 84.9% vs 36.3% 2-year OS: 91.9% vs 86.8% BM MRD negative: 27.3% vs 1.5% | Seymour et al. NCT02005471 [75] | III |
Venetoclax + obinutuzumab | Previously untreated and RR CLL | RR and 1L patients ORR: 95% (41/43) and 100% (32/32) Estimated 24-month PFS: 85.4% and 90.6% Median DOR: 40.9 months and NR (not reached) BM MRD negative: 64% (26/42) and 78% (25/32) | Flinn et al. NCT01685892 [79] | Ib |
Venetoclax + ibrutinib + obinutuzumab | RR CLL | ORR: 92% (11/12) Estimated 24-month PFS: 92% BM and PB MRD negative: 50% (6/12) | Rogers et al. NCT02427451 [76] | Ib |
Venetoclax + R-CHOP/G-CHOP | RR NHL (DLBCL, FL) | ORR of all patients: 87.5% CR/CRi of R-CHOP and G-CHOP: 79.2% and 78.1% 1-year PFS of R-CHOP and G-CHOP: 70% and 100% | Zelenetz et al. NCT02055820 [93] | Ib |
Venetoclax + bendamustine + rituximab | RR NHL (DLBCL, FL, and MZL) | ORR of all patients: 65% Median DOR of all patients: 38.3 months Median PFS of all patients: 10.7 months Median OS of all patients: not reached | De Vos et al. NCT01594229 [91] | Ib |
Venetoclax + ibrutinib | RR or previously untreated MCL | ORR: 71% (17/24) 12-month estimated PFS: 75% 12-month estimated OS: 79% BM MRD negative: 67% (16/24) | Tam et al. NCT02471391 [102] | II |
Venetoclax + bortezomib + dexamethasone | RR MM | ORR: 67% (44/66) Median DOR: 9.7 months Median TTP: 9.5 months | Moreau et al. NCT01794507 [110] | Ib |