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This study was supported by grants from the Instituto de Salud Carlos III grant number PI22/01660 (JE, MD-B) and co-funded by the European Union and Convocatoria d'Intensificacio Interna per als professionals de l'HCB 2023 Emili-Letang (MD-B).

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Hypomethylating agents plus venetoclax for high-risk MDS and CMML as bridge therapy to transplant: a GESMD study

Publicat a:Experimental Hematology And Oncology. 14 (1): 61- - 2025-04-26 14(1), DOI: 10.1186/s40164-025-00652-5

Autors: Zugasti, Ines; Lopez-Guerra, Monica; Castano-Diez, Sandra; Esteban, Daniel; Avendano, Alejandro; Pomares, Helena; Perez, Ana; Conejo, Irene Padilla; de la Fuente Montes, Cristina; Martinez-Roca, Alexandra; Merchan, Beatriz; Jimenez-Vicente, Carlos; Guijarro, Francesca; Alamo, Jose Ramon; Cortes-Bullich, Albert; Torrecillas, Victor; Mont, Lucia; Carcelero, Esther; Riu, Gisela; Zamora, Lurdes; Bargay, Joan; Triguero, Ana; Suarez-Lledo, Maria; Salas, Maria Queralt; Lopez-Cadenas, Felix; Ramos, Fernando; Xicoy, Blanca; Valcarcel, David; Arnan, Montserrat; Martinez, Carmen; Rovira, Montserrat; Fernandez-Aviles, Francesc; Diez-Campelo, Maria; Esteve, Jordi; Diaz-Beya, Marina

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BackgroundHigh-risk myelodysplastic syndromes (HR-MDS) and chronic myelomonocytic leukemia (CMML) remain therapeutic challenges with suboptimal outcomes. The only potentially curative treatment is allogeneic stem cell transplantation (allo-SCT). The most frequent pre-allo-SCT treatment is monotherapy with hypomethylating agents (HMA), but approximately 40% of patients cannot proceed to allo-SCT, mainly due to disease progression. Recent evidence suggests that combining HMA with venetoclax (HMA/VEN) could increase HMA efficacy in HR-MDS but it remains unclear if this combination could bridge more patients to allo-SCT.MethodsWe retrospectively evaluated HMA/VEN as a bridge to allo-SCT in 30 patients with HR-MDS or CMML eligible for transplant. Eighteen patients were treatment-na & iuml;ve and 12 were refractory or relapsed (R/R).ResultsAs defined by the IWG 2023 criteria, the overall response rate (ORR) was 90% and the composite complete response rate was 77%. For the R/R patients, ORR was 83%. The allo-SCT rate was 83%, and the allo-SCT rate of those patients treated exclusively with HMA/VEN without further bridge therapies was 76%. One- and two-year post-allo-SCT survival was 75% and two-year cumulative incidence of relapse was 30.5%. Follow-up of measurable residual disease identified some molecular relapses that were controlled with preemptive treatment.ConclusionsOur findings indicate that HMA/VEN combination therapy shows promise as a bridging strategy to allo-SCT in HR-MDS and CMML.

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