Roche reveals four-year follow-up data for Venclyxto in CLL at EHA2021

Roche has revealed new data from various late-stage trials evaluating its AbbVie-partnered BCL-2 inhibitor Venclyxto, including four-year follow-up analysis from the phase 3 CLL14 study. 

The four-year follow-up data includes a post-hoc analysis of investigator-assessed progression-free survival (PFS), with a median follow-up of 52.4 months.

This analysis showed that the chemotherapy-free Venclyxto (venetoclax) plus Gazyvaro (obinutuzumab) regimen had an estimated PFS rate of 74% in previously untreated patients with chronic lymphocytic leukaemia (CLL) compared to 35% for Gazyvaro plus chlorambucil, three years after completion of a one-year fixed-duration treatment with the regimen.

On top of that, 30 months post-treatment, 26.9% of the Venclyxto-treated patients still had undetectable minimal residual disease (uMRD) compared with just 3.2% of those treated with Gazyvaro plus chlorambucil.

In another post-hoc analysis, this time of the phase 3 VIALE-3 study, acute myeloid leukaemia (AML) patients who achieved a composite complete remission and uMRD following treatment with Venclyxto and azacitidine had improved survival outcomes compared with those who were MRD-positive following treatment.

For the patients who achieved composite complete remission (CCR) and uMRD, a 94% overall survival rate was observed compared to 67.9% for those who did not achieve CCR and uMRD.

“The data from these Venclexta/Venclyxto combinations support our continued commitment to provide valuable therapeutic options for patients with hard-to-treat blood cancers,” said Levi Garraway, chief medical officer and head of global product development, Roche.

“[This] data also advances our understanding of minimal residual disease, which we believe is a useful endpoint that may help identify patients more quickly who are in need of additional treatment,” he added.

In May, the European Commission (EC) approved 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 approval was supported by the VIALE-A study – in the trial, 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 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.