The following article features coverage from the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Click here to read more of MPR‘s conference coverage.


A randomized phase 3 trial (VERONA; ClinicalTrials.gov Identifier: NCT04401748), the details of which were presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, is evaluating the safety and efficacy of venetoclax with azacitidine among patients with previously untreated, higher-risk myelodysplastic syndromes (MDS).

Patients with higher-risk MDS have a high risk of mortality because of peripheral cytopenias and risk of progression to acute myeloid leukemia. While the only treatment option with curative potential is allogeneic hematopoietic cell transplantation (allo-HCT), patients who are ineligible for transplantation may realize a clinical benefit from hypomethylating agents, including azacitidine.

Venetoclax, a B cell lymphoma (BCL-2) inhibitor approved in the United States for the treatment of acute myeloid leukemia alongside hypomethylating agents, showed promise in combination with azacitidine in a previous phase 1b trial evaluating the combination in higher-risk MDS. The authors of the poster presentation evaluated the rationale and details of VERONA, which aims to evaluate any changes in complete remission or overall survival in this patient population.


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All eligible patients will be at least 18 years old and will have newly diagnosed, higher-risk MDS. Patients must be considered intermediate or worse risk by Revised International Prognostic Scoring System criteria, and will either be allo-HCT-eligible without an arranged donor or allo-HCT ineligible.

Patients will be randomly assigned 1:1 to receive venetoclax 400mg as a once-daily oral tablet and azacitidine 7mg/m2, either intravenously or subcutaneously, or azacitidine only. Treatment will continue until disease progression, transplantation, consent withdrawal, or trial discontinuation.

The primary endpoints are complete remission and overall survival; secondary endpoints include red blood cell transfusion independence and platelet transfusion independence. The trial is recruiting as of June 6th, 2021.

Disclosure: The study author(s) declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures. 

Read more of MPR’s coverage of the 2021 ASCO Annual Meeting by visiting the conference page.

Reference

Zeidan AM, Garcia JS, Fenaux P, et al. Phase 3 VERONA study of venetoclax with azacitidine to assess change in complete remission and overall survival in treatment-naïve higher-risk myelodysplastic syndromes. J Clin Oncol. 2021;39:(suppl 15; abstr TPS7054). doi:10.1200/JCO.2021.39.15_suppl.TPS7054

This article originally appeared on Hematology Advisor