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ASCERTAIN-V is the study behind the first all-oral AML regimen, approved in May 2026.
ASCERTAIN-V, trial NCT04657081 sponsored by Taiho Oncology and reported in 2026, is the study behind the first all-oral acute myeloid leukaemia regimen, approved in May 2026. OnCo links it to acute myeloid leukaemia, the oral decitabine and cedazuridine record, venetoclax and the pairing of venetoclax with a hypomethylating agent. The remission rate is in line with the venetoclax-azacitidine arm of VIALE-A, supporting equivalence of the oral backbone, but there is no randomised comparison, which is the open question.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
101 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Complete remissionprimary | Decitabine-cedazuridine + venetoclax | 101 | 41.6% | - | - | link |
Shares Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Venetoclax, Acute myeloid leukaemia.
Shares Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Venetoclax, Acute myeloid leukaemia.
Shares Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Venetoclax, Acute myeloid leukaemia.
Shares Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Venetoclax, Acute myeloid leukaemia.
Shares Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Venetoclax, Acute myeloid leukaemia.
Shares Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Venetoclax, Acute myeloid leukaemia.
Shares Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Acute myeloid leukaemia.
Shares Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET), Acute myeloid leukaemia.