AbbVievenetoclax's first-line treatment of Aza cytosine significantly prolongs OS.

On August 12, AbbVie announced the results of phase 3 clinical trial VIALE-A in the New England Journal of Medicine (NEJM).
the study evaluated the efficacy and safety of venetoclax in combination with azacitidine, a new diagnosis of acute myeloid leukemia (AML) without chemotherapy, and in patients who were not resistant to traditional high-intensity chemotherapy.
results showed that venetoclax dual-drug therapy significantly extended total survival (OS) and reduced the risk of death by 34 percent compared to azalets and placebos.
VIALE-A is a two-arm, randomized, double-blind International Multi-Center Phase 3 clinical study that included 433 untreated AML patients who were not suitable for high-intensity chemotherapy.
in the U.S. Clinical Research Center, OS is the only major endpoint, with composite total remission rate (CR-CRi) and OS as the primary endpoint in China, Japan, and Europe.
ACR-CRi is a comprehensive score that reflects complete remission (CR) and complete hematological recovery (CRi).
results showed that Venetoclax combined azasides reduced the risk of death by 34% compared to placebo-combined azagsins (HR=0.66, 95% CI:0.52-0.85, p<0.001).
OS was 14.7 months (95% CI: 11.9-18.7) and 9.6 months in the placebo group (95% CI: 7.4-12.7).
addition, 66.4% of patients in the venetoclax combined treatment group achieved CR-CRi (95% CI:60.6-71.9), while only 28.3% (95% CI:21.1-36.3) in the placebo group achieved CR-CRi, and the remission rate increased significantly (p.0001).
other secondary endpoints include CR and partial hematological recovery CR and its results published in NEJM.
the safety profile observed in the VIALE-A trial is consistent with the previously known safety of venetoclax in association with azatase.
most common adverse reactions are hematological responses and gastrointestinal diseases, including thyroid reduction, nausea, constipation, neutral granulocyte reduction, fever neutral granulocytic reduction and diarrhea.
the most frequently occurring severe adverse reactions are fever-neutral granulocyte reduction and pneumonia.
3 patients in the venetoclax combination group reported tumor dissolution syndrome during the dose climb, which was not found in the placebo group.
venetoclax was developed by AbbVie and Roche, which jointly commercialized with Roche's Geneneck in the United States and other parts of the world.
the drug has been approved for sale in more than 50 countries and regions around the world.
, the drug has been included in the priority review team for blood tumors.
the results of the VIALE-A trial were presented at the 25th annual meeting of the European Society of Hematology (EHA) in June this year.
AbbVie partners with Geneneck to bring VIALE-A (M15-656), VIALE-C (M16-043) and Phase 1/2 clinical studies M14-358 and M14-Data from 387 were submitted to the FDA to seek accelerated approval of venetoclax combinations of azathytosine, tesythalphone, or low-dose agalycosides for newly diagnosed AML patients 75 years of age and older or with a combination of diseases that are unable to use high-intensity chemotherapy.
AbbVie has also submitted the data to health authorities in other countries around the world.
source: New England Journal of Medicine Publishes Positive Phase 3 Data of Venetoclax Group in Acute Myeloid Leukemia (AML) Patients.