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Table 14 Selected phase I-III clinical trials conducted with Venetoclax (V) as a single (−single-) or combined therapeutic in untreated/pre-treated or non-refractory(−)/refractory patients (Refrac) with Mivebresib (Miv), Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP), Bendamustine (BEND) Rituximab (RIT) Obinutuzumab (OBIN), Cytarabine (CYT), Ibrutinib (IBU) Rituximab (RIT), Bortezomib (BORT) and Dexamethasone (DEX) against Acute Myelogenous Leukemia (AML), Large B-cell Lymphoma (L-BCL), Follicular non-Hodgkin’s Lymphoma (FnHL), Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin’s Lymphoma (NHL), Multiple Myeloma (MM). Objective Response Rates (ORR), Complete Responses (CR) and Partial Responses (PR), expressed as percentage responders (%) are highlighted for disease progression (R/R) patients against R/R with 1/L (1 year treatment) patients. The clinical trials reference numbers highlighted in bold (left column) and the corresponding references highlighted in the column on the right (Ref). Studies where patients were profiled (and their numbers) are highlighted in the Biomarkers column as percentages (%) and ‘-‘indicates no profiling

From: BH3-mimetics: recent developments in cancer therapy

Venetoclax Phase Combined Patients Refrac Disease ORR, CR, PR Biomarkers Ref
NCT02391480 I/II Miv Pre-treated Yes AML 6.66% CR; 6.66% PR HEXIM1, DCXR, ITD/TKD, PTPN11 [423, 424]
NCT02055820 II R-CHOP Pre-treated L-BCL Bcl-2, MYC [425] [426]
NCT02187861 II BEND(B)/
RIT (R)
Untreated (28 d) Yes FnHL 75% V + BR; 69% BR (untreated)
4% V + R (non-Refrac) + 19% V + R (Refrac)
Bcl-2/
Mcl1
[427]
NCT02265731 II RIT (R) Pre-treated Yes CLL 100% (V, ORR); 66.7% (V + R, ORR)
16.7% (V, CR) + 50% (V + R, CR)
[428]
NCT01685892 Ib OBIN Untreated Yes CLL 95% (R/R, ORR); 100% (1/L, ORR)
37%, (R/R, CR) + 78% (1/L, CR)
IGHV, P53, B2 MG, CD38 [429]
NCT02287233 Ib/II CYT Untreated AML 62% CR [430]
NCT02756897 II IBRUTINIB Untreated CLL 88% CR [431]
NCT01594229 Ib BEND/RIT Yes NHL 65% ORR (30%, CR; 35%, PR) Bcl-2 [432]
NCT03755947 III RIT Pre-treated Yes 17p−/TP53−/IGHV-CLL 92.3% ORR; (17.48%, CR) [433,434,435,436,437,438,439]
NCT01794507 Ib BORT/DEX Pre-treated Yes MM 67% ORR Bcl-2 Bcl-xL, Mcl1, [440]
NCT01889186 II -single- Yes del17p-CLL 70% ORR 17P del (50.3%) [441,442,443]
NCT01994837 II -single- Pre-treated AML 19% ORR (6% CR) Bcl-2, Bcl-xL, BH3 Profiling, Mcl1 [444]
NCT01328626 I -single- Yes CLL 79% ORR (20% CR) 17Pdel [435, 443]