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Association details:
| Biomarker: | RUNX1 mutation |
|---|---|
| Cancer: | Acute Myelogenous Leukemia |
| Drug: | Venclexta (venetoclax) (Bcl2 inhibitor) + idasanutlin (RG7388) (MDM2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Safety, Efficacy, Pharmacokinetic (PK) and Biomarker Analyses of BCL2 Inhibitor Venetoclax (Ven) Plus MDM2 Inhibitor Idasanutlin (idasa) in Patients (pts) with Relapsed or Refractory (R/R) AML: A Phase Ib, Non-Randomized, Open-Label Study
Published date:
11/01/2018
Excerpt:
This ongoing, open-label, multicenter study evaluates safety, tolerability and efficacy of Ven+idasa in R/R AML or secondary AML previously treated for an antecedent hematologic disease...34 pts received Ven+idasa across all dose cohorts. The anti-leukemic response rate was 86% in pts with IDH2 mut and 57% in pts with a RUNX1 mut, but only 20% in pts with a TP53 mut…In 14 evaluable pts, those with AML blasts with a high ratio of BCL2:BCLxL or BCL2:MCL1 had a response rate of 100% (5/5) versus 11% (1/9) in pts with low ratios…An anti-leukemic response rate of 50% was seen at dose levels being considered for RP2D (Ven 600mg + idasa 150/200mg). Overall, responses appeared deep and durable.
DOI:
10.1182/blood-2018-99-116013
Trial ID:
