Johnson & Johnson’s BTK inhibitor Imbruvica plus AbbVie and Roche’s Vencylxto demonstrated superiority over Gazyva plus chemotherapy in a new Phase III study.

In elderly and unfit patients with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), fixed-duration Imbruvica (ibrutinib) plus Venclyxto (venetoclax) had superior progression free survival (PFS) compared to Gazyva (Obinutuzumab) plus chlorambucil.

The improvement in PFS was also found to favour Imbruvica/Venclyxto across predefined subgroups, including older patients and patients with higher comorbidity scores.

Median PFS was not reached for Imbruvica/Venclyxto at a median follow-up of 27.7 months – in the Gazyva/chemotherapy group it was 21 months.

At three months after the end of treatment, the undetectable minimal residual disease (uMRD) was also ‘significantly higher’ for the Imbruvica/Venclyxto group versus Gazyva plus chemotherapy in both bone marrow and peripheral blood.

In addition, complete response rates – including CR with incomplete haematologic recovery – were significantly higher for Imbruvica/Venclyxto versus Gazyva/chemotherapy.

“Imbruvica and Venclyxto have complementary mechanisms of action, and the promising results from the CAPTIVATE and GLOW studies show that this all-oral regimen that many patients can take at home may provide an effective, flexible treatment option for patients with CLL/SLL seeking a fixed-duration therapy,” said Craig Tendler, vice president, late development and global medical affairs, oncology, Janssen Research & Development.

Last September, the European Commission (EC) expanded the marketing authorisation for Imbruvica to include treatment-na?ve patients with CLL.

This decision was based on data from the Phase III E1912 study, which showed that previously untreated adults aged 70 years or younger given the drug plus rituximab lived longer without disease progression than those treated with the established chemo-immunotherapy regimen fludarabine, cyclophosphamide and rituximab (FCR).