AbbVie and Roche have reported that its combination of Venclexta/Venclyxto (venetoclax) with obinutuzumab prolonged progression-free survival (PFS) in the Phase III CLL14 trial of treatment-naïve chronic lymphocytic leukaemia (CLL) patients.
The prospective, multi-centre, open-label, randomised trial assessed the chemotherapy-free combination after 12 months of treatment.
In addition to improved PFS, the data showed high complete response (CR) and minimal residual disease (MRD) negativity rates, compared to obinutuzumab plus chlorambucil.
At 24 months, PFS was found to be 88.2% in the venetoclax combination arm versus 64.1% with the obinutuzumab and chlorambucil combination.
CR rates were 49.5% and 23.1%, respectively, while MRD negativity rates in peripheral blood were 75.5% and 35.2%. MRD negativity rates in bone marrow were observed to be 56.9% versus 17.1%. These rates were analysed three months after treatment completion.
Venetoclax is designed to specifically bind to and inhibit the B-cell lymphoma-2 (BCL-2) protein, which is known to prevent self-destruction of tumour cells in blood cancers.
A combination of the drug with obinutuzumab secured US Food and Drug Administration (FDA) approval for previously untreated patients with CLL or small lymphocytic lymphoma (SLL).
AbbVie vice-president and haematology development global head Mohamed Zaki said: “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 US, we look forward to continue working with health authorities worldwide as we aim to bring venetoclax plus obinutuzumab to patients with previously untreated CLL.”
The Phase III CLL14 trial assessed the safety and efficacy of venetoclax plus obinutuzumab in a total of 432 participants.
The primary endpoint of the trial was PFS, while key secondary endpoints included RD negativity in peripheral blood and bone marrow, overall / CR rates, and overall survival (OS).
AbbVie and Roche are co-developing venetoclax, which has approval in more than 50 countries to treat CLL and in combination with azacitidine or decitabine or low-dose cytarabine for acute myeloid leukaemia (AML).