December 6, 2022

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Venclyxto+Gazyvaro for chemotherapy-free first-line treatment of CLL

Venclyxto+Gazyvaro for chemotherapy-free first-line treatment of CLL

 

Venclyxto+Gazyvaro for chemotherapy-free first-line treatment of CLL.  Leukemia bid farewell to chemotherapy: Roche/AbbVie Venclyxto+Gazyvaro fixed course of chemotherapy-free first-line treatment of CLL shows long-lasting results!

Venclyxto+Gazyvaro for chemotherapy-free first-line treatment of CLL

Chronic Lymphocytic Leukemia (CLL, image source: dxline.info)

AbbVie recently announced the results of a 4-year follow-up analysis of the Phase 3 CLL14 study. The data shows that in patients with chronic lymphocytic leukemia (CLL) who have not previously received treatment and have comorbidities, compared with patients receiving standard care chemoimmunotherapy (Gazyvaro + chlorambucil), they received 12-month fixation Patients who took the combined treatment regimen of Venclyxto and Gazyvaro continued to show longer progression-free survival (PFS) and higher negative rate of minimal residual disease (MRD-, that is, undetectable MRD, uMRD) after 3 years of discontinuation of treatment. .

The median follow-up was more than 4 years (52.4 months). Compared with the Gazyvaro+Chlorambucil treatment group, the Venclyxto+Gazyvaro treatment group showed longer PFS (median: less than 36.4 months) and disease progression Or the risk of death was reduced by 67% (HR=0.33; 95%CI: 0.25-0.45). Four years after randomization, the disease progression-free survival rate was 74% in the Venclyxto+Gazyvaro treatment group, and 35.4% in the Gazyvaro+Chlorambucil treatment group. Improvements in PFS were observed in all clinical and biological risk groups, including patients with TP53 mutation, 17p deletion, and unmutated IGHV status.

In addition, the peripheral blood MRD assessment 30 months after the end of treatment showed that 26.9% of the patients in the Venclyxto+Gazyvaro treatment group were still unable to detect MRD (<10E-4), while the Gazyvaro+Chlorambucil treatment group was only 3.2%. Undetectable MRD (uMRD, also known as MRD negative [MRD-]) is an objective evaluation tool, defined as: using sensitive analysis methods, the proportion of residual CLL cells in the blood or bone marrow is less than 1/10000 white blood cells.

In the 4-year follow-up analysis, no new safety signals were observed. Among patients treated with Venclyxto+Gazyvaro, the most common serious adverse reactions (>=2%) were pneumonia, sepsis, febrile neutropenia and tumor lysis syndrome (TLS).

CLL is the most common type of leukemia in adults. It is a slow-growing type of leukemia characterized by a large number of immature lymphocytes in the blood and bone marrow. CLL accounts for about one-third of newly diagnosed leukemia cases. In recent years, despite advances in treatment, many patients cannot tolerate the side effects of chemotherapy regimens.

Based on the results of the Phase 3 CLL14 study, the Venclyxto+Gazyvaro program has been approved by U.S. and European regulatory agencies to treat adult CLL patients with comorbidities as the first-line treatment. Venclyxto+Gazyvaro, as a fixed course of treatment without chemotherapy, provides an important treatment option for CLL patients. These patients can benefit from deep remission and continuous progression-free survival, as well as the additional benefits of a limited course of treatment.

Othman Al Sawaf, chief investigator of the CLL14 study and hematology oncologist at the University Hospital of Cologne, Germany, said: “CLL is considered an incurable disease. When a patient relapses, it becomes more difficult to treat. Therefore, the key treatment is The goal is to keep the condition in remission for as long as possible. The 4-year results of the CLL14 study showed that 74% of patients who received a fixed course of Venclyxto+Gazyvaro treatment did not have a PFS event more than 3 years after the treatment was stopped. This highlights The persistence of remission after 12 fixed courses of treatment for the vast majority of patients indicates that the Venclyxto+Gazyvaro combination regimen is an effective option for previously untreated CLL patients.”

venetoclax (Venetoclax) is a first-in-class, oral, selective B-cell lymphoma factor-2 (BCL-2) inhibitor, developed by AbbVie and Roche, and the two parties are jointly responsible for the commercialization of the US market (trade name) : Venclexta) and AbbVie is responsible for commercialization in markets outside the United States (trade name: Venclyxto). BCL-2 protein plays an important role in cell apoptosis (programmed cell death), can prevent the apoptosis of some cells (including lymphocytes), and is overexpressed in certain types of cancer, which is related to the formation of drug resistance. venetoclax is designed to selectively inhibit the function of BCL-2, restore the cell communication system, allow cancer cells to destroy themselves, and achieve the purpose of treating tumors.

venetoclax has been approved in more than 80 countries around the world for the treatment of chronic lymphocytic leukemia (CLL), small cell lymphoma (SLL), and acute myeloid leukemia (AML). In the United States, venetoclax has been granted 5 Breakthrough Drug Designations (BTD) by the FDA, one for the first-line treatment of CLL, two for the first-line treatment of relapsed or refractory CLL, and two for the first-line treatment of acute myeloid leukemia (AML).

In China, venetoclax (Venetoclax®, Veneclax) was approved in December 2020 to be used in combination with azacitidine for the treatment of comorbidities that are not suitable for strong induction chemotherapy, or new diagnoses aged 75 years and older Of adult patients with acute myeloid leukemia (AML). venetoclax (Venetoclax®) is China’s first approved B-cell lymphoma factor-2 (BCL-2) inhibitor, marking the Chinese AML field has entered the era of targeted therapy.

Obinutuzumab (Gazyva/Gazyvaro) is a product developed by Roche. This is the first glycosylated type II anti-CD20 monoclonal antibody that targets CD20 molecules on the surface of B cells and can directly induce B cell death. Obinutuzumab is designed to enhance antibody-dependent cytotoxicity (ADCC) and direct cell death induction (Direct Cell Death induction). The brand name of obinutuzumab in the United States is Gazyva and the brand name in Europe is Gazyvaro.

 

(source:internet, reference only)


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