Talha Badar: What is the right duration of Venetoclax with HMA for AML?

Talha Badar, Assistant Professor of Oncology at Mayo Clinic Comprehensive Cancer Center, shared on X/Twitter:

“Weekend review.

What is the right duration of Venetoclax with HMA for AML: 7 days vs 14 days vs 21 days or 28 days?

Brief review of literature in this thread:

VIALE-A trial recommends AZA for seven days combined with VEN for 28 days for every 28 days.

However, in RWD it is associated with significant myelosuppression, especially high TRM in elderly patients.

Christophe Willekens from France evaluated 82 AML pts with 7+7 regimen: ASH22

m Age 75, 29% meets exclusion criteria of VIALE-A

56% sAML, 70% adverse risk, 37% PS 2-4

CR/CRi 41.5% C1, 53.9% C2
EFS 7.5 &OS 12.8 m

Better who met VIALE-A criteria; EFS and OS 11.4 and 13.8 m

Authors from Albert Einstein College of Medicine explored Weekly low dose decitabine and VEN in MDS and AML.

39 patients: ORR in AML and MDS was 88% and 64%

In TP53m AML, CRc 71%, mOS 10.7m

Authors concluded non-cytotoxic sustained drug exposure often not possible with standard Rx.

Another study from China including 36 patients: 14 days of Ven at 100 mg OD (without azoles) + 7 days of AZA

OS and PFS 17 (4–29) and 12 (1–28) mo,

ORR: 69.4%, CRc 66.7%

G3-4 cytopenia 25-44% less frequent then VIALE-A

Our data on 301 patients.

28 days of Venetoclax not better than 21/14 days.

14D may be suitable for favorable and 21D for adverse AML.

G3 or > ⬇️ ANC & ⬇️ Plt; 45%/48%, 39%/38, 42%/41%, among patients receiving Venetoclax for 14, 21, and 28 D; p  NS

CR/CRi were comparable b/w 3 gp

In conclusion, continuous Venetoclax dosing should be avoided to prevent prolong cytopenia.

Sustained drug exposure is needed for better outcome.

Venetoclax dosing should be individualised based on pt and disease related features.

Prospective studies are needed to better address this debate!”

Proceed to the article of Albert Einstein College of Medicine.
Proceed to the article of Taylor and Francis Online.
Proceed to the article of AJH.
Source: Talha Badar/X