ASCERTAIN-V
ASCERTAIN-V is the study behind the first all-oral AML regimen, approved in May 2026.
Single-arm phase 2 in adults ≥75 or with comorbidities: CR 41.6% (42 of 101), median time to CR 2 months, with safety comparable to IV hypomethylating agent plus venetoclax. Basis for the 13 May 2026 FDA approval of Inqovi with venetoclax.
- 41.6 out of 100 people had no sign of cancer on scans or tests with Decitabine-cedazuridine + venetoclax.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Newly diagnosed AML unfit for intensive induction: oral decitabine-cedazuridine + venetoclax. People in a different situation may not see the same effect.
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 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Complete remissionprimary | Decitabine-cedazuridine + venetoclax | 101 | 41.6% | — | — | link |
Pages like this
not linked directly; found by shared links- CompanyTaiho Oncology (Otsuka)
Shares Decitabine + cedazuridine (oral), Acute myeloid leukaemia.
- IdeaShorter venetoclax courses in unfit AML
Shares Decitabine + cedazuridine (oral), Venetoclax, Acute myeloid leukaemia.
- TrialVIALE-A
Shares Venetoclax + hypomethylating agent, Venetoclax, Acute myeloid leukaemia.
- Key paperVIALE-A: venetoclax plus azacitidine for older adults with acute myeloid leukaemia who cannot have intensive chemotherapy
Shares Venetoclax + hypomethylating agent, Venetoclax, Acute myeloid leukaemia.
- PersonAnthony Letai
Shares Venetoclax, Acute myeloid leukaemia.
- TermHypomethylating agents (azacitidine, decitabine)
Shares Venetoclax, Acute myeloid leukaemia.
- TermTumour lysis syndrome (TLS)
Shares Venetoclax, Acute myeloid leukaemia.
- InstitutionWalter and Eliza Hall Institute of Medical Research
Shares Venetoclax, Acute myeloid leukaemia.