AbbVie has announced that a phase 2 study of venetoclax, an investigational oral B-cell lymphoma-2 (BCL-2) inhibitor, met its primary endpoint of achieving overall response rates in patients with relapsed/refractory or previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion.
“The results from this study demonstrate the clinical activity of venetoclax in patients with relapsed/refractory CLL who have 17p deletion, a patient population that has historically been difficult to treat,” said Michael Severino, MD, executive vice president of research and development and chief scientific officer, AbbVie, in North Chicago, Ill.
For the multicenter, international, open-label, phase 2 clinical trial, researchers evaluated the safety and efficacy of venetoclax in 50 and 107 patients, respectively, with previously untreated or relapsed/refractory CLL and 17p deletion.
Venetoclax is being evaluated in phase 3 clinical trials for the treatment of patients with relapsed/refractory CLL, as well as with studies in various other cancers.
AbbVie will use the trial results as pivotal registration data for applications to the U.S. Food and Drug Administration (FDA), as well as the European Medicines Agency (EMA).
“Based on these results, we intend to advance regulatory submissions for venetoclax and remain committed to the further development of this investigational medicine, and others in our pipeline, with the goal of delivering new treatment options for people affected by cancer,” Dr. Severino said.
The American Cancer Society estimates that there will be approximately 14,620 new cases of CLL diagnosed in the United States in 2015. Of those, about 3% to 10% are estimated to have 17p deletion at diagnosis. These patients have a median life expectancy of less than 2 to 3 years.
- Phase 2 study of venetoclas in patients with relapsed/refractory chronic lymphocytic leukemia with 17p deletion meets primary endpoint [news release]. North Chicago, IL: AbbVie; August 12, 2015. http://www.prnewswire.com/news-releases/phase-2-study-of-venetoclax-in-patients-with-relapsedrefractory-chronic-lymphocytic-leukemia-with-17p-deletion-meets-primary-endpoint-300127232.html. Accessed August 14, 2015.