AbbVie Presents Data on Venetoclax Chemo-Free Leukemia Combo

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today presented data from the CLL14 trial, the first randomized 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 minimal residual disease (MRD)-negativity compared to a commonly used standard of care 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).

“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.”

The venetoclax and obinutuzumab combination was recently approved by the U.S. Food and Drug Administration (FDA) for previously untreated patients with CLL or small lymphocytic lymphoma (SLL) based on results from the CLL14 clinical trial.

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<0.001). Higher rates of MRD-negativity were observed with venetoclax plus obinutuzumab compared to obinutuzumab plus chlorambucil in both peripheral blood (75.5 percent versus 35.2 percent, P<0.001) and bone marrow (56.9 percent versus 17.1 percent [P<0.001]) three months after treatment completion, and complete response rates were significantly higher with venetoclax plus obinutuzumab than with chlorambucil plus obinutuzumab (49.5 percent versus 23.1 percent [P<0.001]).¹ 

“The combination of venetoclax plus obinutuzumab is a new and rational approach to treat patients with previously untreated CLL and coexisting medical conditions based on the results of the CLL14 trial,” said Michael Hallek, M.D., chairman of the German CLL Study Group (DCLLSG), Department of Internal Medicine and Center of Integrated Oncology at the University Hospital Cologne in Germany, and lead study investigator. “The CLL14 trial results show that a finite treatment duration induces a longer time without progression when compared to a conventional chemoimmunotherapy.”

https://www.biospace.com/article/releases/abbvie-presents-data-from-venetoclax-chemotherapy-free-combination-regimen-for-patients-with-previously-untreated-chronic-lymphocytic-leukemia/