The venetoclax, obinutuzumab combination met the primary endpoint of the late-stage trial called CLL14, which was investigator-assessed progression-free survival (PFS).
The combination therapy, which was administered for a fixed duration of 12 months, brought down the risk of disease worsening or death by 65%, in comparison to obinutuzumab plus chlorambucil.
The CLL14 study featured 432 patients with previously untreated CLL and co-existing medical conditions.
As per the findings of the study, at two years, one year after stopping treatment, 88.2% of patients in the venetoclax, obinutuzumab arm remained progression-free, in comparison to 64.1% recorded in the obinutuzumab plus chlorambucil arm.
The treatment benefit shown with the venetoclax, obinutuzumab combination compared to obinutuzumab plus chlorambucil was consistent for the secondary endpoints of the phase 3 trial, which included overall response, complete response with at least partial blood count recovery and minimal residual disease (MRD)-negativity in the bone marrow.
Last month, the chemotherapy-free combination therapy was approved by the US Food and Drug Administration (FDA) under the FDA’s Real-Time Oncology Review and Assessment Aid pilot programmes, for the treatment of previously untreated CLL or small lymphocytic lymphoma.
AbbVie vice president, hematology development global head Mohamed Zaki said: “Conducting CLL14 was another collaborative and bold attempt to continue pushing the boundaries of treatment in CLL.
“The combination of venetoclax plus obinutuzumab significantly prolonged progression-free survival and patients maintained that benefit after stopping treatment. After the recent approval in the U.S., we look forward to continue working with health authorities worldwide as we aim to bring venetoclax plus obinutuzumab to patients with previously untreated CLL.”
Safety for the chemotherapy-free combination therapy was observed to be in line with the known safety profiles of the constituent medicines.
Roche chief medical officer and global product development head Sandra Horning said: “We are pleased this fixed-duration, chemotherapy-free regimen of Venclexta/Venclyxto plus Gazyva/Gazyvaro was approved by the FDA and look forward to providing an important treatment option to even more adults with the most common form of adult leukaemia.”
Venetoclax, which is jointly being developed by AbbVie and Roche, is a targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. Obinutuzumab, which was developed by Roche, is an engineered monoclonal antibody designed to bind to CD20, a protein expressed on some B-cells, but not on stem cells or plasma cells.