AbbVie Reveals Positive CLL Data at American Society of Hematology

Published: Dec 07, 2015

AbbVie Reveals Positive CLL Data at ASH
December 7, 2015
By Alex Keown, Breaking News Staff

ORLANDO, Fla. – AbbVie Inc. unveiled positive data for the treatment of the blood disorder chronic lymphocytic leukemia (CLL) this weekend during the American Society of Hematology meeting. The company's experimental CLL treatment Venetoclax showed a nearly 80 percent positive response rate.

Before the hematological conference began, BioSpace sat down with Moma Vidakovic, Abbvie’s director of oncology operations and pharmaceutical development, in an exclusive interview about the company’s drugs in development.

“This is a really exciting time with what we’re seeing in these treatments,” Vidakovic said. “We really have a robust set of compounds that provides us with a toolbox to attack these cancers.”

Venetoclax is an investigational oral B-cell lymphoma-2 (BCL-2) inhibitor that is being investigated for the treatment of CLL and other blood disorders. The drug works by blocking the BCL-2 protein and “telling” the cancer cells to die, giving the healthy cells room to grow. Venetoclax, which is being developed in combination with Genentech and its parent company Roche , is currently in Phase III trials for the treatment of CLL.

During a Sunday presentation at ASH, AbbVie and Roche presented Phase II data, which showed venetoclax achieved primary efficacy endpoints with 79.4 percent of patients showing an overall response rate. Additionally, 7.5 percent of patients achieved a complete response with or without complete recovery (complete response without normal blood counts) in the bone marrow. Of the patients treated with venetoclax, 84.7 percent of patients maintained a duration of response for approximately 12 months. Perhaps most notably, 18 patients who took venetoclax achieved minimal residual disease-negativity, meaning no cancer could be detected using a specific test. Ten of these 18 people also had bone marrow assessments and six were MRD-negative.

Vidakovic said targeted cancer therapies are promising and they’re hoping to see rapid progression of their therapies.

“We are really hoping the medical community shares the excitement we have about venetoclax,” Vidakovic said.

CLL is one of the most common forms of blood cancer. It is expected that approximately 4,650 people in the United States will die from CLL complications each year. There are some CLL medications on the market, including Rituxan, Campeth, AbbVie’s Imbruvica (acquired earlier in 2015 from Pharmacyclics, Inc. and Arzerra.

AbbVie submitted a New Drug Application for venetoclax to the U.S. Food and Drug Administration (FDA) under breakthrough therapy designation, based in part on results of the trial data presented at ASH. Venetoclax received the breakthrough therapy designation earlier this year for the treatment of people with relapsed or refractory CLL harboring the 17p deletion. Additionally, AbbVie filed a marketing authorization application with the European Medicines Agency (EMA).

In addition to data on venetoclax, AbbVie also presented new data on Imbruvica. Acquired earlier this year, AbbVie is hoping to receive approval from the FDA to expand its use for CLL patients. Phase III trial data shows the drug significantly decreased the risk of progression or death of patients with CLL by 84 percent over an 18-month period. Additionally, Imbruvica significantly improved hematologic function as measured by sustained improvements in hemoglobin and platelets, the company said in its presentation. Imbruvica is an inhibitor of Bruton's tyrosine kinase (BTK), as a single-agent and in combination with other therapies in several hematologic malignancies, including CLL, mantle cell lymphoma, follicular lymphoma, multiple myeloma and diffuse large B-cell Lymphoma.

Another blood cancer treatment AbbVie highlighted at ASH is elotuzumab, an investigational immunostimulatory antibody targeted against Signaling Lymphocyte Activation Molecule Family 7, a cell-surface glycoprotein that is highly expressed on multiple myeloma cells and Natural Killer (NK) cells. In 2014, the U.S. FDA granted elotuzumab Breakthrough Therapy Designation for use in combination with one of the chemotherapy treatments for multiple myeloma in patients who have received one to three prior treatments.

Another clinical trial therapy AbbVie will feature during the conference is for Duvelisib, an investigational dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins that are known to help support the growth and survival of malignant B-cells.

Not only will the ASH conference be a time to tout the robust pipeline to treat hematological disorders being developed by AbbVie, the conference also provides the companies avenues to talk about possible collaborations with other pharmaceutical companies.

Because cancer in all its forms is such a multifaceted medical issue, Gentry Lassiter, AbbVie’s manager of public affairs, said it will take multiple healthcare institutions to work together to find effective treatments for the disease.

Currently, AbbVie has several collaborative deals, including working with Roche and Genentech on venetoclax, with Bristol-Myers Squibb on elotuzumab, with Infinity Pharmaceuticals for the development of Duvelisib, and another project with Johnson & Johnson , Vidakovic said.

“When you’re trying to partner with someone from the outside, it’s a tremendous help,” Vidakovic said. “The collaboration with Roche and Genentech (for venetoclax) has been very fruitful.”

Vidakovic added he was interested in seeing what other drug companies present during ASH that could lead to “potential cancer treatment synergies.”

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