AbbVie’s anticancer drug venetoclax succeeds in pivotal Phase II clinical trial for refractory blood cancer


Release time:

2018-05-24

Recently, venetoclax, an oncology drug jointly developed by Roche and AbbVie, was successful in a pivotal Phase II clinical trial (M13-982) for blood cancers, paving the way for the drug's regulatory application. . AbbVie plans to submit marketing applications for venetoclax to the United States (FDA) and the European Union (EMA) by the end of the year. Some analysts cannot help but predict that venetoclax is likely to become a blockbuster drug.

  Recently, venetoclax, an oncology drug jointly developed by Roche and AbbVie, was successful in a pivotal Phase II clinical trial (M13-982) for blood cancers, paving the way for the drug's regulatory application. . AbbVie plans to submit marketing applications for venetoclax to the United States (FDA) and the European Union (EMA) by the end of the year. Some analysts cannot help but predict that venetoclax is likely to become a blockbuster drug.

  M13-982 is an open-label, single-arm, multicenter Phase II study in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) carrying a 17p deletion mutation (del 17p). The data showed that venetoclax monotherapy achieved a clinically significant reduction in the number of cancer cells in patients, reaching the primary endpoint of the study (overall response rate, ORR). Detailed data from the study will be presented at an upcoming scientific meeting.

  In May this year, the FDA granted venetoclax Breakthrough Drug Designation (BTD) for the treatment of relapsed or refractory CLL carrying 17p deletion mutations. This is the eighth BTD obtained by Roche and the second BTD in hematology. The abnormal chromosomal deletion mutation del 17p is associated with cancer progression and drug resistance. del 17p refers to the loss of part of chromosome 17. Patients carrying this mutation are considered to have the worst prognosis. It is estimated that approximately 30-50% of patients with relapsed or refractory CLL carry 17p deletion mutations, making the disease difficult to treat and typically leading to an average life expectancy of less than 3 years.

  Venetoclax is an inhibitor of B-cell lymphoma factor-2 (BCL-2), a protein that represents a new target for the treatment of blood cancers. Venetoclax has the potential to help restore the natural process that allows leukemia cells to self-destruct, and represents a new treatment option for CLL patients with 17p deletion mutations who have a very poor prognosis and limited treatment options.

  The success of venetoclax is particularly critical to AbbVie. In March this year, the company successfully acquired Pharmacyclics from Johnson & Johnson for US$21 billion, successfully acquiring a breakthrough antibiotic with unlimited potential and a perfect complement to its own oncology pipeline. Sales rights for the cancer drug Imbruvica in the U.S. market. So far, Imbruvica has received four indications in the United States and is expected to bring $1 billion in revenue to AbbVie this year, while establishing the company's strong presence in the fast-growing oncology treatment market. The industry expects Imbruvica's peak annual sales to exceed US$5 billion. AbbVie believes that venetoclax combined with Imbruvica will create a first-in-class combination therapy for the clinical treatment of blood cancers.

  About venetoclax :

  Venetoclax is an experimental B-cell lymphoma factor-2 (BCL-2) inhibitor jointly developed by Roche and AbbVie. BCL-2 plays an important role in apoptosis (programmed cell death) and can prevent the apoptosis of some cells, including lymphocytes. Venetoclax is designed to selectively inhibit the function of BCL-2, restore the cell communication system, and allow cancer cells to self-destruct to achieve the purpose of treating tumors.

  The BCL-2 protein is involved in the development of drug resistance in some blood cancers and is expressed in chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL). Roche is currently working with AbbVie on a large-scale clinical project to investigate venetoclax monotherapy and combination therapy for the treatment of multiple types of blood cancers, including CLL, NHL, diffuse large B-cell lymphoma (DLBCL), and acute myeloid leukemia (AML). and multiple myeloma (MM).

Related News

2022.11

2023-08-08

2022.08

2023-08-08

2022.05

2023-08-08

2021.02

2023-08-08

2020.12

2023-08-08

2020.09

2023-08-08