Phase 1b study of venetoclax in combination with azacitidine in patients with treatment-naïve higher-risk myelodysplastic syndromes.

Fong, Chun Yew; Wei, Andrew H.; Frattini, Mark G.; Jacoby, Meagan A.; Borate, Uma; Götze, Katharina; Garcia, Jacqueline S.; Pollyea, Daniel A.; Holes, Leanne; Zhou, Ying; Fakouhi, Kaffa; Leverson, Joel D.; Harb, Jason G.; Agarwal, Suresh; Attarchi, Faraneh; Mabry, Mack; Hong, Wan‐Jen; Jahn, Thomas M.; Fenaux, Pierre

doi:10.1200/jco.2018.36.15_suppl.tps7082

Cited by 4 publications

(2 citation statements)

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“…As overexpression of the B-cell lymphoma 2 (BCL-2) protein has been linked to disease progression in MDS, studies are ongoing to investigate the efficacy and safety of venetoclax, a BCL-2 inhibitor, in patients with MDS either first-line or refractory or resistant to HMAs. [16][17][18] Preliminary results from a phase Ib study investigating the combination of venetoclax and azacitidine (AzaC) for 14 days in a 28-day cycle in up-front higher-risk MDS (IPSS int-2 or high) resulted in an ORR, median overall survival (OS), median progression-free survival, and median duration of response of 77%, not reached (95% CI, 16.2 months-not estimable), 17.5 months (14.5 months-not estimable), and 14.8 months (95% CI, 12.9 months-not estimable), respectively. 17 The most frequent grade $3 adverse events were neutropenia (51%), febrile neutropenia (46%), and thrombocytopenia (30%).…”

Section: Management Of Higher-risk Mdsmentioning

confidence: 99%

NCCN Guidelines® Insights: Myelodysplastic Syndromes, Version 3.2022

Greenberg

Stone

Al‐Kali³

et al. 2022

Journal of the National Comprehensive Cancer Network

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The NCCN Guidelines for Myelodysplastic Syndromes (MDS) provide recommendations for the evaluation, diagnosis, and management of patients with MDS based on a review of clinical evidence that has led to important advances in treatment or has yielded new information on biologic factors that may have prognostic significance in MDS. The multidisciplinary panel of MDS experts meets on an annual basis to update the recommendations. These NCCN Guidelines Insights focus on some of the updates for the 2022 version of the NCCN Guidelines, which include treatment recommendations both for lower-risk and higher-risk MDS, emerging therapies, supportive care recommendations, and genetic familial high-risk assessment for hereditary myeloid malignancy predisposition syndromes.

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Section: Management Of Higher-risk Mdsmentioning

confidence: 99%

NCCN Guidelines® Insights: Myelodysplastic Syndromes, Version 3.2022

Greenberg

Stone

Al‐Kali³

et al. 2022

Journal of the National Comprehensive Cancer Network

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“…Finally, trials evaluating the up-front management of MDS patients with venetoclax-based regimens are ongoing and are expected to yield favorable results [ 28 ]. Early concerns regarding infectious complications have been quieted, and venetoclax may soon be approved in this indication as well.…”

Section: Treatmentmentioning

confidence: 99%

Salvage Therapy after Allogeneic Hematopoietic Cell Transplantation: Targeted and Low-Intensity Treatment Options in Myelodysplastic Syndrome and Acute Myeloid Leukemia

Culos¹,

Byrne²

2019

CHI

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Patients with high-risk myeloid neoplasms, including myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), are offered allogeneic hematopoietic cell transplantation (alloHCT) to improve the likelihood of long-term disease control. More than 50% of patients with high-risk disease will relapse after HCT and face a poor prognosis with shortened survival. The recent development of targeted therapies and effective, low-intensity treatment strategies will likely improve the outcomes of these patients. In MDS, hypomethylating agents (HMAs) are the mainstay of salvage therapy but new treatments with APR-246 and luspatercept demonstrate excellent results in phase 1 and phase 3 clinical studies, respectively. In AML, new directed agents in the relapsed/refractory setting include gilteritinib (FLT3-ITD/-TKD), ivosidenib (IDH1), and enasidenib (IDH2). In patients without targetable mutations, HMAs may be used, and early data with venetoclax-based regimens are encouraging.

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SOHO State of the Art & Next Questions: Myelodysplastic Syndromes: A New Decade

Volpe

Komrokji

2022

Clinical Lymphoma Myeloma and Leukemia

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Phase 1b study of venetoclax in combination with azacitidine in patients with treatment-naïve higher-risk myelodysplastic syndromes.

Cited by 4 publications

References 0 publications

NCCN Guidelines® Insights: Myelodysplastic Syndromes, Version 3.2022

NCCN Guidelines® Insights: Myelodysplastic Syndromes, Version 3.2022

Salvage Therapy after Allogeneic Hematopoietic Cell Transplantation: Targeted and Low-Intensity Treatment Options in Myelodysplastic Syndrome and Acute Myeloid Leukemia

SOHO State of the Art & Next Questions: Myelodysplastic Syndromes: A New Decade

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