Venclexta And Azacitidine Fail to Enhance MDS Survival

Sufferers with revised worldwide prognostic scoring system intermediate and high-risk myelodysplastic syndrome (MDS) didn’t expertise an total survival (OS) enchancment from the remedy mixture of Venclexta (venetoclax) plus azacitidine in comparison with placebo, research outcomes have proven.

Outcomes from the part 3 VERONA trial had been offered on the 2025 Society of Hematologic Oncology Annual Assembly.

Within the mixture arm, the median OS was 22.18 months versus 21.68 months within the placebo arm. The modified total response fee (ORR) within the Venclexta/azacitidine arm was 76.2%. The marrow full response (CR) fee was 57.8%, the partial response (PR) fee was 0.4% and the CR fee was 18%. Within the placebo arm, the modified ORR was 57.7%, the marrow CR fee was 37.5% and the CR fee was 20.2%.

The general hematological enchancment within the mixture arm was 49.4% in contrast with 41.2% within the placebo arm. The transfusion independence charges had been 55.7% versus 33.6%, respectively. The median length of transfusion independence was 183 days vs 294 days.

“Subgroup analyses [showed] [Venclexta] plus azacitidine trended towards an mOR profit versus placebo plus azacitidine for sufferers with greater than 5% to lower than 20% bone marrow blasts for ASXL1, TP53 and RUNX1 mutations at baseline,” Dr. Guillermo Garcia-Manero, chair advert interim within the Division of Leukemia, Division of Most cancers Drugs, fellowship program director within the Division of Leukemia, and Dr. Kenneth B. McCredie Chair in Scientific Leukemia Analysis amongst different titles, at The College of Texas MD Anderson Most cancers Middle in Houston, stated through the presentation.

A complete of 509 sufferers had been randomly evenly assigned to both the mixture or placebo arms. Sufferers got Venclexta at 400 mg by mouth day by day on days 1 to 14 plus azacitidine at 75 mg/m² intravenously or subcutaneously for seven of the primary 9 days. The placebo plus azacitidine arm matched the mixture arm’s dosing. Sufferers continued remedy till relapse, progressive illness, hematopoietic stem cell transplant (HSCT) or unacceptable toxicity. Sufferers then transitioned to follow-up.

The median follow-up was 41.2 months, the median length of remedy was 6.4 months and the median variety of cycles was six.

No new security alerts had been noticed. The most typical any-grade treatment-emergent negative effects included neutropenia (77.3% versus 60.2%), thrombocytopenia (66.3% versus 58.9%), anemia (44.7% versus 38.2%) and constipation (42.4% versus 50.4%) between the mixture and placebo arms of the trial, respectively.

Critical negative effects resulting in remedy discontinuation occurred in 41.6% of sufferers within the mixture arm and 55.3% of sufferers within the placebo arm, whereas dose interruption was famous in 78.8% versus 67.9% of sufferers and dose discount of Venclexta or placebo was present in in 12.5% versus 6.9% whereas azacitidine was 48.6% versus 27.2%.

Unintended effects resulting in loss of life included illness development (1.6% versus 0.8%), septic shock (1.2% versus 0.8%), sepsis (0.4% versus 0.8%) and acute myeloid leukemia transformation (0.4% versus 0.8%) amongst sufferers within the mixture and placebo arms, respectively. The most typical reason behind loss of life was illness development (39.2% versus 40.7%) and negative effects (10.6% versus 11.4%).

Reference

1. Garcia-Manero G, Platzbecker U, Fenaux P, et al. Main evaluation of the randomized part 3 VERONA research of venetoclax plus azacitidine versus placebo with azacitidine in sufferers with treatment-naïve, intermediate and higher-risk myelodysplastic syndromes. Offered on the 2025 Society of Hematologic Oncology Annual Assembly, Houston, TX; September 3-6, 2025. Summary MDS-1497.

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