82 - All-Oral Treatment of Newly Diagnosed Acute Myeloid Leukemia
TMO EPM
78 views
In this episode we discuss ASCERTAIN-V — an all-oral regimen (decitabine-cedazuridine + venetoclax) for newly diagnosed acute myeloid leukemia (AML) in patients ineligible for intensive chemotherapy, eliminating the need for parenteral infusion of the hypomethylating agent.
The study (Roboz GJ, Zeidan AM, Mannis GN, et al. All-Oral Treatment of Newly Diagnosed Acute Myeloid Leukemia. N Engl J Med 2026;394:2107-16 — NCT04657081; sponsored by Astex/Taiho): phase 1-2, open-label, multicenter, non-randomized, single-arm (34 centers in the US, Canada, and Spain). Population: newly diagnosed AML (WHO 2022), aged 75 years or older, or 18 years or older and ineligible for intensive chemotherapy. Regimen: Oral decitabine-cedazuridine (35mg/100mg, D1-5) + venetoclax 400mg/day, 28-day cycles.
Main results — pivotal phase 2b (n=101), primary endpoint CR (verified in the article):
CR 47% (95% CI 36-57) — pre-specified bar reached.
CR+CRi (composite) 63% (53-73); sustained CR at 12 months 75%.
Negative MRD in 55% of evaluated responders (27/49; exploratory analysis).
Median overall survival 15.5 months (95% CI 7.6-NE); median follow-up 11.2 months.
Mortality 3% at 30 days / 10% at 60 days.
No relevant drug interactions between decitabine-cedazuridine and venetoclax.
12 patients from the entire study (N=189), even those ineligible, underwent allogeneic transplantation.
Single-arm study: no direct comparator and no hazard ratio. Comparison with parenteral regimens (e.g., VIALE-A) is indirect.
Presentation: Lucas Salviano (Fellow — Hospital Nove de Julho).
Discussion: Carol Marques, Rafael Faust, Israelita Tihara, Pedro Moraes, and Vinícius Molla.
Journal Club of Onco-Hematology and Bone Marrow Transplantation — EPM/Unifesp · Hospital Nove de Julho.
Educational content; does not replace individualized clinical decision-making.
Instagram: @tmoepm
Chapters:
00:00 Introduction
00:18 Presentation — ASCERTAIN-V (phase 1-2 design, pharmacokinetics, efficacy and safety) · Lucas Salviano
14:56 Discussion
82 - All-Oral Treatment of Newly Diagnosed Acute Myeloid Leukemia
TMO EPM
78 views
In this episode we discuss ASCERTAIN-V — an all-oral regimen (decitabine-cedazuridine + venetoclax) for newly diagnosed acute myeloid leukemia (AML) in patients ineligible for intensive chemotherapy, eliminating the need for parenteral infusion of the hypomethylating agent.
The study (Roboz GJ, Zeidan AM, Mannis GN, et al. All-Oral Treatment of Newly Diagnosed Acute Myeloid Leukemia. N Engl J Med 2026;394:2107-16 — NCT04657081; sponsored by Astex/Taiho): phase 1-2, open-label, multicenter, non-randomized, single-arm (34 centers in the US, Canada, and Spain). Population: newly diagnosed AML (WHO 2022), aged 75 years or older, or 18 years or older and ineligible for intensive chemotherapy. Regimen: Oral decitabine-cedazuridine (35mg/100mg, D1-5) + venetoclax 400mg/day, 28-day cycles.
Main results — pivotal phase 2b (n=101), primary endpoint CR (verified in the article):
CR 47% (95% CI 36-57) — pre-specified bar reached.
CR+CRi (composite) 63% (53-73); sustained CR at 12 months 75%.
Negative MRD in 55% of evaluated responders (27/49; exploratory analysis).
Median overall survival 15.5 months (95% CI 7.6-NE); median follow-up 11.2 months.
Mortality 3% at 30 days / 10% at 60 days.
No relevant drug interactions between decitabine-cedazuridine and venetoclax.
12 patients from the entire study (N=189), even those ineligible, underwent allogeneic transplantation.
Single-arm study: no direct comparator and no hazard ratio. Comparison with parenteral regimens (e.g., VIALE-A) is indirect.
Presentation: Lucas Salviano (Fellow — Hospital Nove de Julho).
Discussion: Carol Marques, Rafael Faust, Israelita Tihara, Pedro Moraes, and Vinícius Molla.
Journal Club of Onco-Hematology and Bone Marrow Transplantation — EPM/Unifesp · Hospital Nove de Julho.
Educational content; does not replace individualized clinical decision-making.
Instagram: @tmoepm
Chapters:
00:00 Introduction
00:18 Presentation — ASCERTAIN-V (phase 1-2 design, pharmacokinetics, efficacy and safety) · Lucas Salviano
14:56 Discussion