Summary

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• Venclexta (venetoclax) is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL); in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
• This summary is based on the review of nine systematic review(s)/meta-analysis(es). ^[1-9]
• Multiple Myeloma (MM): Venetoclax (VEN) demonstrated an Overall Response Rate (ORR) of 68% (51%-85%) in relapsed or refractory MM patients, with higher efficacy observed in patients with t(11;14) translocation or high BCL-2 expression. Multi-drug treatments including VEN achieved a superior ORR of 82% compared to 42% with VEN ± dexamethasone (Dex) (p = .003).
• Acute Myeloid Leukemia (AML): In newly diagnosed AML patients treated with VEN + hypomethylating agents (HMAs), the pooled median survival was 9.37 months (95% CI 8.81-10.5), which was lower than the VIALE-A trial's 14.7 months (95% CI 11.9-18.7). VEN + azacytidine (AZA) showed a median survival of 11.5 months (95% CI 10.2-14.8).
• Chronic Lymphocytic Leukemia (CLL): VEN + obinutuzumab significantly improved progression-free survival (PFS) compared to most treatments. Network meta-analysis showed that VEN + rituximab and ibrutinib monotherapy significantly improved PFS and overall survival (OS) compared to ofatumumab.
• Acute Myeloid Leukemia (AML) / Myelodysplastic Syndromes (MDS): Neutropenia was the most common grade 3-4 adverse event (AE) with a rate of 53.7%, alongside frequent occurrences of cytopenia and infection. Combination therapies generally led to more frequent AEs compared to control arms, with the exception of the ivosidenib plus azacitidine regimen.
• Chronic Lymphocytic Leukemia (CLL): Venetoclax monotherapy commonly resulted in adverse events such as nausea, diarrhea, neutropenia, fatigue, and thrombocytopenia. Severe (grade ≥ 3) AEs included thrombocytopenia, anemia, febrile neutropenia, and leukopenia, with a high overall event rate of 73% when combined with other drugs.
• Higher efficacy of Venetoclax (VEN) was observed in specific subgroups, including patients with t(11;14) translocation or high BCL-2 expression in Multiple Myeloma (MM), better survival outcomes in Acute Myeloid Leukemia (AML) patients receiving VEN + azacytidine (AZA) compared to general VEN + Hypomethylating Agents (HMA), higher complete response rates in newly diagnosed AML compared to relapsed/refractory AML, and higher efficacy in chronic lymphocytic leukemia (CLL) patients who were fludarabine-ineligible or had relapsed/refractory disease.