Venetoclax

Overview

Venetoclax is a type of drug called a Bcl-2 inhibitor. The Bcl-2 protein is found on some cancer cells, and helps them survive, sometimes making them more resistant to treatment. Venetoclax works by blocking the action of the Bcl-2 protein, which may help to cause cancer cell death.

SparkCures ID 24
Developed By AbbVie
Generic Name Venetoclax
Additional Names ABT-199
Treatment Classifications

Clinical Trials

All Clinical Trials

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Early Relapse Multiple Myeloma

The following is a listing of clinical trials for patients with multiple myeloma who have received one to two prior lines of therapy.

Late Relapse Multiple Myeloma

The following is a listing of clinical trials for patients with multiple myeloma who have received three or more prior lines of therapy.

Smoldering Myeloma
Monoclonal Gammopathy of Undetermined Significance (MGUS)

Published Results

Final Overall Survival Results from BELLINI, a Phase 3 Study of Venetoclax or Placebo in Combination with Bortezomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma

December 11, 2021

Results: Of 291 randomized pts (194 to Ven and 97 to Placebo), 33 pts were receiving ongoing treatment (28 with Ven and 5 with Placebo) as of the final OS analysis data cutoff (March 15, 2021). At a median follow-up of 45.6 months, there were 78 (40%) deaths in the Ven arm versus 36 (37%) in the Placebo arm. Updated PFS and OS among all pts and those with t(11;14) or high BCL2 expression are shown in the Table. Among all pts, the median PFS per investigator was 23.4 months in the Ven arm versus 11.4 months in the Placebo arm (HR, 0.58 [95% CI, 0.43–0.78]). In pts with t(11;14), the median PFS was 36.8 months in the Ven arm versus 9.3 months in the Placebo arm (HR, 0.12 [95% CI, 0.03–0.44]). In pts with high BCL2, the median PFS was 30.1 months in the Ven arm versus 9.9 months in the Placebo arm (HR, 0.37 [95% CI, 0.21–0.64]). Median OS was not reached in the Ven or Placebo arm among all pts (HR, 1.19 [95% CI, 0.80–1.77]), pts with t(11;14) (HR, 0.61 [95% CI, 0.16–2.32]), pts with high BCL2 (HR, 0.70 [95% CI, 0.32–1.51]), and pts with t(11;14) or high BCL2 (HR, 0.82 [95% CI, 0.40–1.70]).

The most common treatment-emergent adverse events (AEs) with Ven (versus Placebo) were diarrhea (60% versus 50%), nausea (38% versus 23%), and constipation (35% versus 31%). The most common Grade 3/4 AEs (Ven versus Placebo) were thrombocytopenia (16% versus 30%), neutropenia (23% versus 8%), pneumonia (19% versus 13%), anemia (16% versus 15%), and diarrhea (15% versus 11%). Serious AEs occurred in 57% of Ven- and 55% of Placebo-treated pts, with serious infections and infestations occurring in 35% and 29% of pts, respectively. Overall, 26% of pts in the Ven arm and 11% of pts in the Placebo arm experienced an AE leading to Ven or Placebo discontinuation. AEs led to 12 deaths in the Ven arm, with 9 of these deaths due to serious infection; an AE led to 1 death in the Placebo arm. A total of 16 (6%) treatment-emergent deaths occurred (14 [7%] with Ven and 2 [2%] with Placebo), with 3 of these deaths due to disease progression (2 [1%] with Ven and 1 [1%] with Placebo).

Resources

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