Leukemia farewell chemotherapy! Roche/AbbVie combination therapy Venclyxto-Gazyvaro first-line treatment with commodronation CLL:

AbbVie and Roche recently jointly announced positive results for the evaluation of CLL14 in a Phase III clinical study evaluating Venclexta/Venclyxto's combination therapy with Gazyva/Gazyvaro (obinutuzumab) for the first-line treatment of chronic lymphocytic leukemia (CLL). It is worth mentioning that another combination developed by the two sides, venetoclax and Merova, was approved by the FDA in June this year for second-line treatment of CLL or small cell lymphoma (SLL);
CLL14 is a forward-looking, multi-center, open-label, randomized Phase III study that is being conducted in collaboration with the German CLL Research Group (DCLLSG) to assess the efficacy and safety of CLL patients who have not been treated in the past and who have not been treated in the same combination. The study included 445 patients, all of which had not previously been treated, according to the International Symposium on Chronic Lymphocytic Leukemia (iwCLL). In the study, patients received a fixed period of treatment for 12 months. The main endpoint is the progress-free lifetime (PFS) assessed by investigators based on the iwCLL standard.
results show that the study reached the main end point: compared with the obinutuzumab-benzoic acid nitrogen mustard combination scheme, the venetoclax-obinutuzumab combination scheme significantly extended PFS. Preliminary analysis showed that the safety profile of the venetoclax-obinutuzumab combination scheme in the study was consistent with the safety profile of each drug when used alone. Details of the study will be presented at a future medical conference.
, Roche's chief medical officer and head of global product development, said CLL patients still needed more treatment options because some patients were unable to withstand chemotherapy because of commodronism. The CLL14 study is the first to confirm that the venetoclax-obinutuzumab combination scheme significantly extends progress-free survival relative to standard care options. We will work with health authorities to make this chemotherapy-free program available to patients as soon as possible.
, executive vice president and chief scientific officer of research and development at AbbVie, says CLL patients often face ongoing treatment for life to prevent the disease from returning. The positive results of the CLL14 study further confirm the potential of venetoclax as a fixed course drug to treat CLL and can be extended to first-line therapy. We look forward to sharing the full results of the CLL14 study and promoting other clinical development projects in the pipeline that have the potential to continue to change the standard of care for patients with blood cancer.
CLL is a slow-growing type of leukemia characterized by the appearance of large numbers of immature lymphocytes in the blood and bone marrow. CLL accounts for about one-third of new leukemia cases.
venetoclax is an oral B-cell lymphoma factor-2 (BCL-2) inhibitor that plays an important role in apoptosis (programmed cell death) and prevents apoptosis of some cells, including lymphocytes, and overexpression in some types of cancer, associated with the formation of drug resistance. Venetoclax aims to selectively inhibit the function of BCL-2, restore the cell's communication system, allow cancer cells to self-destruct, and achieve the goal of treating tumors.
was developed by AbbVie in partnership with Roche, who are jointly responsible for the commercialization of the drug in the U.S. market, and AbbVie, which is responsible for the commercialization of markets outside the U.S. Currently, a large-scale clinical project is under way to investigate the treatment of a variety of types of blood cancers, including CLL, Hodgkin's lymphoma (NHL), diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML) and multiple myeloma (MM).
obinutuzumab is the first glyco-based type II anti-CD20 monoclonal antibody, targeting CD20 molecules on the surface of B cells and directly inducing B cell death. obinutuzumab is designed to enhance antibody-dependent cytotoxicity (ADCC) and direct cell death induction. Obinutuzumab's U.S. brand is called Gazyva and its European brand is Gazyvaro. (Bio Valley)