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
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 | |
NCT02055820 | II | R-CHOP | Pre-treated | – | L-BCL | – | Bcl-2, MYC | |
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) | – | |
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%) | |
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 |