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09-Jun-2019

AbbVie Presents Data from VENCLYXTO®▼(venetoclax) Chemotherapy-Free Combination Regimen for Patients with Previously Untreated Chronic Lymphocytic

Phase 3 CLL14 data were highlighted in an oral presentation (abstract #7502) today at ASCO and published in the New England Journal of Medicine Patients treated with venetoclax plus obinutuzumab lived significantly longer without their disease progressing, and sustained that benefit after stopping treatment, compared to those treated with obinutuzumab plus chlorambucil Rates of undetectable minimal residual disease* in peripheral blood were higher in patients treated with venetoclax plus obinutuzumab three months after treatment completion1 MAIDENHEAD, UK, 4 June, 2019 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today presented data from the CLL14 trial, the first randomised clinical trial to examine stopping an oral-based, chemotherapy-free combination after 12 months in previously untreated patients with CLL and coexisting medical conditions. The results demonstrate that venetoclax plus obinutuzumab prolonged progression-free survival (PFS) and achieved higher rates of complete response and undetectable minimal residual disease (uMRD) compared to a commonly used chemoimmunotherapy obinutuzumab plus chlorambucil.1 These data were presented today in an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (abstract #7502) and were simultaneously published in the New England Journal of Medicine (NEJM). *Undetectable minimal residual disease (uMRD), is defined as the presence of less than one CLL cell in 10,000 white blood cells remaining in the blood or bone marrow following treatment.2 Dr Angus Broom, Consultant Haematologist at the Western General Hospital in Edinburgh and CLL14 Study Investigator, said: “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. 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.” CLL is the most common form of adult leukaemia, or blood cancer, in which too many immature lymphocytes (a type of white blood cell) are found predominantly in the blood and bone marrow.3,4. Over 3,500 people are diagnosed with CLL in the UK each year.5 The average age of CLL diagnosis is 72 years and almost 90% of CLL patients have one or more co-morbidities.3,6 Although many patients diagnosed with CLL will be put on a ‘Watch and Wait’ management strategy, around two thirds will eventually require treatment.7 In the CLL14 trial, investigator-assessed results demonstrated that patients with CLL who were treated with venetoclax plus obinutuzumab achieved superior PFS compared to patients treated with obinutuzumab plus chlorambucil. Twenty-four-month PFS estimates were 88.2 percent and 64.1 percent, respectively (hazard ratio [HR]: 0.35, 95% confidence interval [CI]: 0.23, 0.53; P<0.0001). Higher rates of uMRD were observed with venetoclax plus obinutuzumab compared to obinutuzumab plus chlorambucil in both peripheral blood (75.5 percent versus 35.2 percent, P<0.0001) and bone marrow (56.9 percent versus 17.1 percent [P<0.0001]) three months after treatment completion.1 uMRD in the blood or bone marrow is an important therapeutic goal in patients with CLL as it can be associated with prolonged PFS and overall survival (OS).8 Complete response rates were also significantly higher with venetoclax plus obinutuzumab than with chlorambucil plus obinutuzumab (49.5 percent versus 23.1 percent [P<0.0001]).1 "Conducting CLL14 was another collaborative and bold attempt to continue pushing the boundaries of treatment in CLL,” said Mohamed Zaki, M.D., Ph.D., vice president, global head of hematology development, AbbVie. “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.” In the CLL14 trial, the safety profile of both treatment groups showed no new safety signals or increase in known toxicities.1 Venetoclax is being developed by AbbVie and Roche. It is commercialised by AbbVie outside of the U.S. and jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the U.S.

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Last Updated: 10-Jun-2019