Blood cancers

VIALE-C data support use of venetoclax in AML patients not eligible for intensive chemo


New clinical research supports the use of venetoclax plus low-dose cytarabine (LDAC) as a frontline treatment option for patients with acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.

In the VIALE-C trial, led by haematologist Professor Andrew Wei, from The Alfred Hospital and Monash University in Melbourne, 211 patients were randomised to receive either venetoclax/LDAC (143) or placebo/LDAC (68).

Initially, at the primary analysis (at which point around 60% of patients had been in the study for less than 6 months), a statistically significant improvement in overall survival (OS) was not shown with the venetoclax regimen, but it did show prolonged median OS (7.2 versus 4.1 months, respectively), as well as a 25% reduction in the risk of death.

However, improved efficacy was observed following an additional six months of follow-up, with a significant increase in median OS in the venetoclax/LDAC arm (8.4 months) versus the placebo/LDAC group (4.1 months). Venetoclax was linked with a 30% reduction in the risk of death.

The venetoclax regimen also significantly outperformed the control group on complete response (CR)/CR with incomplete haematologic recovery (48.3% vs.13.2%, respectively), transfusion independence rates (43% vs.19%) and median event-free survival (4.9 vs. 2.1 months).

Rates of post-study treatment were found to differ “notably” between the two arms, the researchers said, with 29% of patients in the venetoclax arm receiving any subsequent therapy compared to 50% of the placebo arm. Also, a lower frequency of patients in the venetoclax arm (8%) were given intensive chemotherapy after the study versus the placebo group (22%).

The six-month follow-up period revealed no new safety concerns, with the incidence of grade ≥3 adverse events found to be comparable between study arms while overall safety profiles were similar to those observed in the study’s primary analysis.

Neutropenia, thrombocytopenia, and febrile neutropenia were the most-commonly reported ≥3 adverse events, and all were recorded at a higher frequency with venetoclax (49%, 46%, and 32%, respectively) compared to placebo (18%, 38%, and 29%, respectively).

The authors concluded that the new analysis “shows that in addition to its manageable safety profile, venetoclax improves key efficacy measures including OS, CR rates, transfusion independence, and EFS compared with LDAC alone in a durable manner, confirming its promise in this subset of older patients with AML who serve to benefit from an effective, less intensive therapeutic option.”

The findings are published in Blood Cancer Journal.

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