EC approves Venclyxto-based combinations for newly diagnosed AML

The European Commission (EC) has approved Roche and AbbVie’s Venclyxto in combination with azacitidine and decitabine for the treatment of newly diagnosed acute myeloid leukaemia (AML) patients who can’t receive intensive chemotherapy. 

The new approval is based on two studies – the phase 3 VIALE-A and phase 1/2 M14-358 studies of Venclyxto (venetoclax) plus hypomethylating agents in adults with newly diagnosed AML who are ineligible for intensive chemotherapy.

In the VIALE-A study, Venclyxto plus azacytidine reduced the risk of death by 34% compared to azacytidine alone, with a median overall survival of 14.7 months in the Venclyxto group compared to 9.6 months in the control group.

In addition, the Venclyxto combination more than doubled the rate of complete responses (CRs), with a CR rate of 37% compared to 18% in the control arm.

The Venclyxto plus azacytidine treatment combination also resulted in higher rates of composite complete remission – 66% compared to 28% for the control group.

The most common adverse events were mostly haematology and gastrointestinal in nature, with the most frequent serious adverse reactions being febrile neutropenia and pneumonia.

On top of the VIALE-A study, results from the M14-358 trial found that patients receiving Venclyxto in combination with decitabine achieved a CR and CR with incomplete blood count recovery (CRi) of 74%.

“This Venclyxto approval is a critical step in providing new therapeutic options for patients in the EU newly diagnosed with AML who cannot tolerate the side effects of, or are ineligible for, intensive chemotherapy,” said Levi Garraway, chief medical officer and head of global product development, Roche.

“Venclyxto-based combinations continue to show meaningful clinical benefits in AML patients, who would otherwise have a poor prognosis,” he added.

In the US, Venclyxto is approved as Venclexta in combination with azacitidine, decitabine, or low dose cytarabine for the treatment of newly diagnosed AML in adults aged 75 years and older, or who have comorbidities that prevent the use of intensive induction chemotherapy.

Venclyxto/Venclexta is a targeted medicine designed to inhibit the B-cell lymphoma-2 (BCL-2) protein.

In some blood cancers, such as AML, this protein builds up and can prevent cancer cells from self-destructing (apoptosis).

By blocking the BCL-2 protein, Venclyxto helps to restore the process of apoptosis, resulting in cancer cell death.