AbbVie Presents Extended Follow-Up Data for Fixed Duration Treatment VENCLEXTA®/VENCLYXTO® (venetoclax) in Chronic Lymphocytic Leukemia (CLL)
AbbVie Presents Extended Follow-Up Data for Fixed Duration Treatment VENCLEXTA®/VENCLYXTO® (venetoclax) in Chronic Lymphocytic Leukemia (CLL) - New five-year, follow-up analysis from the Phase 3 MURANO trial shows median progression-free survival (PFS) of 53.6 months in previously treated CLL patients taking VENCLEXTA/VENCLYXTO in combination with rituximab compared to 17.0 months in patients taking bendamustine plus rituximab (BR) after three years or more off treatment[1] |
[05-December-2020] |
NORTH CHICAGO, Ill., Dec. 5, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new, updated results from the Phase 3 MURANO and CLL14 clinical trials evaluating VENCLEXTA®/VENCLYXTO® (venetoclax) fixed duration treatment combinations at the virtual 62nd American Society of Hematology (ASH) Annual Meeting & Exposition (abstracts 125, 127, and 1310, respectively). These findings add to the growing body of data supporting the use of VENCLEXTA/VENCLYXTO in first-line or previously treated chronic lymphocytic leukemia (CLL) patients. "MURANO and CLL14 provide a look at the benefits of fixed duration VENCLEXTA combinations in helping many patients to achieve sustained progression-free survival," said John Hayslip, M.D., M.S.C.R., executive medical director, AbbVie. "These responses reinforce that with VENCLEXTA/VENCLYXTO, it is possible for CLL patients to complete treatment and live longer without their disease progressing." Data from the MURANO and CLL14 trials presented at ASH reinforce that CLL patients who have relapsed or have not started treatment and receive a VENCLEXTA/VENCLYXTO regimen can experience long-lasting responses, even after stopping treatment, compared to standard of care treatment options. MURANO Five-Year Analysis1
According to the Leukemia & Lymphoma Society, MRD refers to the small number of cancer cells that remain in the body after treatment.4 The number of remaining cells may be so small that they do not cause any physical signs or symptoms and often cannot even be detected through traditional methods, this is known as undetectable MRD (uMRD). Doctors use MRD/uMRD to measure the effectiveness of treatment and to predict which patients are at risk of relapse. CLL14 Analyses2,3 One analysis showed that patients with previously untreated CLL and co-existing medical conditions who had partial response (PR) after treatment with VENCLEXTA/VENCLYXTO in combination with obinutuzumab (Ven-Obi) had a similar outcome as patients with complete response (CR) when uMRD levels were achieved. These data suggest that patients on the VENCLEXTA/VENCLYXTO combination with uMRD levels and PR had longer PFS than patients with MRD and CR. This is significant because patients with CLL who show a PR to chemoimmunotherapy have a poorer prognosis than patients with CR.2 These results were not tested for statistical significance. (Abstract 1310) The second analysis looked at clonal growth patterns – or how quickly cancer cells grow and spread – in patients treated within the CLL14 trial. The findings from the analysis shed light on which patient group may be at risk of relapsing despite initial MRD response.3 (Abstract 127) The four-year, follow-up analysis showed an OS rate of 85.3% with Ven-Obi versus 83.1% with chlorambucil in combination with obinutuzumab (Obi-Clb; HR 0.85, 95% CI [0.54-1.35]; P=0.4929). VENCLEXTA is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. About the MURANO Trial5,6,7 The trial met its primary efficacy endpoint of INV-assessed PFS. At the time of the primary analysis, median PFS with VenR was not reached compared with 17.0 months for BR (HR: 0.17; 95% CI: 0.11- 0.25; p<0.0001). In the primary efficacy analysis, the median follow-up for PFS was 23.8 months (range: 0 to 37.4). Additional efficacy endpoints included independent review committee (IRC)-assessed PFS, INV- and IRC-assessed overall response rate (defined as complete response + complete response with incomplete marrow recovery + partial response + nodular partial response), OS and rates of MRD-negativity. In patients with CLL receiving combination therapy with rituximab, the most frequent serious adverse reaction (AR; ≥5%) was pneumonia (9%). The most common ARs (≥20%) of any grade were neutropenia (65%), diarrhea (40%), upper respiratory tract infection (39%), fatigue (22%), and nausea (21%). Fatal ARs that occurred in the absence of disease progression and within 30 days of the last venetoclax treatment and/or 90 days of the last rituximab were reported in 2% (4/194) of patients. About the CLL14 Trial6,7,8 Key secondary endpoints were MRD-negativity in peripheral blood and bone marrow, overall and complete response rates, MRD-negativity in complete response in peripheral blood and bone marrow, and OS. In patients with CLL receiving combination therapy with obinutuzumab, serious ARs were most often due to febrile neutropenia and pneumonia (5% each). The most common ARs (≥20%) of any grade were neutropenia (60%), diarrhea (28%), and fatigue (21%). Fatal ARs that occurred in the absence of disease progression and with onset within 28 days of the last study treatment were reported in 2% (4/212) of patients, most often from infection. About VENCLEXTA®/VENCLYXTO® (venetoclax) VENCLEXTA/VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers. VENCLEXTA/VENCLYXTO is approved in more than 50 countries, including the U.S. Uses and Important VENCLEXTA® (venetoclax) U.S. Safety Information7 Uses
It is not known if VENCLEXTA is safe and effective in children. Important Safety Information What is the most important information I should know about VENCLEXTA? VENCLEXTA can cause serious side effects, including: Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with VENCLEXTA. It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain. Drink plenty of water during treatment with VENCLEXTA to help reduce your risk of getting TLS. Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased. Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you have side effects. When restarting VENCLEXTA after stopping for 1 week or longer, your healthcare provider may again check for your risk of TLS and change your dose. Who should not take VENCLEXTA? Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased because of the risk of increased TLS.
Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions, including if you:
What should I avoid while taking VENCLEXTA? You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood. What are the possible side effects of VENCLEXTA? VENCLEXTA can cause serious side effects, including:
Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with VENCLEXTA. The most common side effects of VENCLEXTA when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell counts; low platelet counts; low red blood cell counts; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of your arms, legs, hands, and feet. The most common side effects of VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure. VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility. These are not all the possible side effects of VENCLEXTA. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. If you cannot afford your medication, contact genentech-access.com/patient/brands/venclexta for assistance. The full U.S. prescribing information, including Medication Guide, for VENCLEXTA can be found here. See VENCLYXTO full summary of product characteristics (SmPC) at https://www.ema.europa.eu/en/documents/product-information/venclyxto-epar-product-information_en.pdf. Globally, prescribing information varies; refer to the individual country product label for complete information. About AbbVie in Oncology About AbbVie Forward-Looking Statements 1 Kater AP, et al. Abstract 125: Five-Year Analysis of Murano Study Demonstrates Enduring Undetectable Minimal Residual Disease (uMRD) in a Subset of Relapsed/Refractory Chronic Lymphocytic Leukemia (R/R CLL) Patients (Pts) Following Fixed-Duration Venetoclax-Rituximab (VenR) Therapy (Tx). Presented at the 2020 American Society of Hematology Annual Meeting & Exposition: December 5, 2020. View original content:http://www.prnewswire.com/news-releases/abbvie-presents-extended-follow-up-data-for-fixed-duration-treatment-venclextavenclyxto-venetoclax-in-chronic-lymphocytic-leukemia-cll-301186833.html SOURCE AbbVie | ||
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