August 12, 2015
By Alex Keown, BioSpace.com Breaking News Staff
SOUTH SAN FRANCISCO – A promising experimental leukemia drug developed by Genentech and AbbVie yielded a positive result in reducing the number of cancer cells in patients with previously treated (relapsed or refractory) chronic lymphocytic leukemia (CLL), the companies announced jointly this morning.
Venetoclax, a small molecule inhibitor of the BCL-2 protein, is designed to treat chronic lymphocytic leukemia patients harboring the 17p deletion, which represents 30 to 50 percent of people with relapsed or refractory chronic lymphocytic leukemia, Sandra Horning, Genentech’s chief medical officer and head of Global Product Development, said in a statement. People with this type of CLL typically have a median life expectancy of less than three years.
“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,” Horning said.
Michael Severino, executive vice president of research and development and chief scientific officer at AbbVie, said his company remains “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.”
Wall Street has been keeping a close eye on the drug all spring. An AbbVie exec told BioSpace exclusively in December that venetoclax could also be effective in a variety of hematological malignancies, including chronic lymphocytic leukemia and non-Hodgkin’s lymphoma. Gary Gordon, vice president of oncology clinical development at AbbVie, said in an interview with BioSpace that venetoclax has multiple properties that could make it just as effective against other indications as it was when treating acute myelogenous leukemia (AML). AbbVie’s announcement at the American Society of Hematology‘s annual meeting certainly turned heads in December.
Chronic lymphocytic leukemia is one of the most common forms of blood cancer and in 2015, it is expected that there will be about 4,650 deaths from CLL in the United States. In certain cases of CLL, a part of chromosome 17 is lost and along with it an important gene that controls apoptosis (programmed cell death) called p53. The 17p deletion is found in 3 to 10 percent of previously untreated cases and approximately 30 to 50 percent of relapsed or refractory cases. People with 17p deletion chronic lymphocytic leukemia have poor results with conventional chemotherapy regimens and a median life expectancy of less than three years.
In collaboration with AbbVie, venetoclax is being evaluated in a development program as a single agent or in combination with other medicines. There are ongoing Phase II and III studies for venetoclax in CLL, and Phase I and II studies are also ongoing in several other blood cancers, including indolent NHL, diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML) and multiple myeloma (MM), Genentech said. No safety issues were discovered during the mid-stage trial.
In May the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation for venetoclax. Breakthrough therapy designation is designed to accelerate the development and review of medicines intended to treat serious and life-threatening diseases with evidence showing that the medicines may provide a substantial improvement over current treatment options
Venetoclax was already granted Orphan Drug Designation last March by the FDA for the treatment of diffuse large B-cell lymphoma (DLBCL), an aggressive type of lymphoma and the most common form of NHL
The companies plan to submit regulatory applications to the FDA, European Medicines Agency (EMA) by the end of 2015.
Genentech’s pipeline of potential hematology medicines includes an antibody-drug conjugate (anti-CD79b; polatuzumab vedotin) and a small molecule antagonist of MDM2 (RG7388). AbbVie’s oncology research and development efforts are exploring therapies for multiple cancers, including glioblastoma multiforme, multiple myeloma and chronic lymphocytic leukemia. AbbVie‘s oncology pipeline includes multiple new molecules in clinical trials being studied in more than 15 different cancers and tumor types.
