AbbVie’s Venclyxto combo outclasses chemo in treatment-naive chronic lymphocytic leukaemia

pharmafile | June 5, 2019 | News story | Research and Development ASCO 2019, AbbVie, Venclyxto, pharma 

AbbVie was one of many companies to present new data at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, focusing specifically on its B-cell lymphoma-2 (BCL-2) inhibitor Venclyxto (venetoclax) in combination with obinutuzumab in the treatment of previously untreated chronic lymphocytic leukaemia (CLL).

In the first randomised trial to investigate stopping an oral-based, chemotherapy-free combination after 12 months in the disease, it was found that the drug combo, which AbbVie is jointly developing with Roche, achieved superior rates of progression-free survival (PFS), complete response and undetectable minimal residual disease (uMRD) compared to the common chemoimmunotherapy obinutuzumab plus chlorambucil. PFS estimates after 24 months of treatment were placed at 88.2% for the Venclyxto combo compared to 64.1%, while complete response rates stood at 49.5% for the combo compared to 23.1%.

Three months following completion of treatment, uMRD rates were lower in the Venclyxto group in peripheral blood (75.5% versus 35.2%) and bone marrow (56.9% versus 17.1%).

“The results of the Phase 3 CLL14 clinical trial, presented today at the annual American Society of Clinical Oncology and published in the prestigious New England Journal of Medicine (NEJM), highlight that a one year fixed treatment duration of venetoclax plus obinutuzumab induces a longer time without disease progression compared to a commonly used chemoimmunotherapy, in previously untreated, unfit CLL patients,” explained Dr Angus Broom, Consultant Haematologist at the Western General Hospital and an investigator on the Venclyxto study. “Improved progression-free survival with this chemotherapy-free regimen was also demonstrated after stopping treatment, as well as higher rates of uMRD, compared to obinutuzumab plus chlorambucil.”

Dr Mohamed Zaki, Vice President, Global Head of Haematology Development at AbbVie, added: “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 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.”

Matt Fellows

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