AbbVie's Venclyxto shows promise as AML treatment

AbbVie has presented new data showing the potential of Venclyxto (venetoclax) to reduce the risk of death in previously untreated patients with acute myeloid leukaemia (AML) who were ineligible for intensive chemotherapy.

According to results of the VIALE-A (M15-656) trial, patients treated with Venclyxto plus azacitidine achieved a 34% reduction in the risk of death compared with azacitidine in combination with placebo.

The study met its primary endpoints of statistically significant improvement of overall survival (OS), with the patients in the Venclyxto combination arm achieving median OS of 14.7 months versus 9.6 months for those in the placebo arm.

The study also met secondary endpoints of composite complete remission (CR), which is CR with incomplete count recovery. The Venclyxto combination arm showed a CR rate of 36.7% (versus 17.9% in the placebo arm), a CR with partial haematologic recovery (CRh) rate of 64.7% (versus 22.8%) and a composite complete remission rate (CR + CRi) of 66.4% (versus 28.3%).

Also of note, the study observed a safety profile generally consistent with the known safety profiles of Venclyxto combined with azacitidine and of the two medications alone.

AML is the most common acute blood cancer in the world, and also one of the most aggressive and difficult to treat. In the UK alone, there are around 3,200 new cases every year, and not all patients are eligible to receive intensive chemotherapy. Just 28% of patients will survive five years or more.

“I am greatly encouraged by the VIALE-A data, which demonstrate that the venetoclax-azacitidine combination could have the potential to significantly improve the lives of people with AML who aren’t eligible for intensive chemotherapy,” said Belinda Byrne, Medical Director at AbbVie UK.

Venetoclax is not currently licensed for AML in the UK. The drug has been approved for three indications in the chronic lymphocytic leukaemia (CLL) landscape, and the data for AML will now be submitted to global regulatory authorities, the firm noted.

CLL data

Also at the European Hematology Association (EHA) congress, AbbVie presented new research from venetoclax in patients who are previously untreated and patients with BIRC3-mutated relapsed/refractory (R/R) CLL.

The Phase III CLL14 trial evaluated the combination of fixed duration venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab, a commonly used chemoimmunotherapy, in previously untreated CLL patients off treatment for at least two years.

At Year 3, data confirmed sustained progression free survival (PFS) of the venetoclax combination versus chemoimmunotherapy, with estimated PFS for the venetoclax combination 81.9% compared with 49.5% for patients on chemoimmunotherapy.

In addition, subgroup analyses from the Phase III MURANO trial, evaluating BIRC3-mutated R/R CLL patients treated with a fixed duration of venetoclax plus rituximab, reported PFS and undetectable minimal residual disease (uMRD) responses based on four-year follow-up.

The analyses found that there was no PFS reduction observed, and nearly half of the patients were able to achieve and maintain uMRD, which the firm said “supports the use of time-limited, chemotherapy-free venetoclax plus rituximab in R/R CLL patients with BIRC3 mutation”'.