Phase II Study of Investigational Medicine Venetoclax Meets Primary Endpoint With Positive Results

Phase II Study of Investigational Medicine Venetoclax Meets Primary Endpoint With Positive Results

Genentech in partnership with AbbVie Pharmaceuticals and the Leukemia & Lymphoma Society (LLS), recently announced positive results from a Phase 1 clinical trial for venetoclax, an investigational therapy to treat patients with a high-risk subset of chronic lymphocytic leukemia (CLL)

About Chronic Lymphocytic Leukemia

CLL is a slow moving blood cancer that most often begins to develop in the patient’s bone marrow. It is a rare form of leukemia, with current rates in the US of about 126,000 patients.

About the Clinical Trial

The Phase 2 trial assessed a cohort of 157 patients with relapsed or refractory CLL harboring a chromosome deletion known as the 17p deletion, in which 50 of these patients were enrolled in a safety expansion group.  The primary study endpoint investigated the drug’s overall response rate (ORR) as determined by an independent review committee.  The secondary endpoints included complete response (CR), partial response (PR) and progression-free survival (PFS).

The results showed that treatment with venetoclax resulted in a clinically meaningful reduction in the number of cancer cells which meant the study met its primary endpoint.  There were also no unexpected safety events observed throughout the trial.

In a company press release Dr. Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, stated “Approximately 30 to 50 percent of people with relapsed or refractory chronic lymphocytic leukemia have the 17p deletion that makes their disease difficult to treat. Venetoclax may help restore the natural process that allows these leukemic cells to self-destruct, representing a potential new way of helping people with this form of CLL who typically have a poor prognosis and limited treatment options.”

In an LLS press release, Dr. Louis J. DeGennaro, PhD, president and CEOof LLS, explained, “We have seen remarkable advances in treatments for patients with CLL over the past two years.This therapy, in particular, is targeting a rare subset of patients with CLL who have a very poor prognosis and we are hopeful that these results will ultimately lead to a new drug approval. It is gratifying to see work we have supported for so many years finally yielding positive outcomes for patients who desperately need new options.”

This announcement comes after the U.S. Food and Drug Administration (FDA) granted a Breakthrough Therapy Designation for venetoclax in May of this year, for the treatment of previously treated CLL with the 17p deletion.  This designation facilitated an expedited review and drug development process.

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