Acartini vs. Ibtini treatment CLL head-to-head trial reaches the main therapeutic end point

On January 25, AstraZeneca's official website showed that Calquence's Phase III ELEVATE-RR study for adult patients treated with high-risk chronic lymphoblastic leukemia (CLL) had reached the primary endpoint of non-progressive survival.
ELEVATE-RR study is the first Phase III clinical study to compare the efficacy of two Bruton tyrosine kinase (BTK) inhibitors head-to-head in CLL patients (the most common type of leukemia in adults).
The study also reached a critical secondary endpoint, with a lower incidence of adverse atrial fibrillation in patients in the Calquence group than in the Ibteinie group (atrial fibrillation is a common type of arrhythmic disorder, and the risk of stroke, heart failure, and other heart-related complications increased significantly in patients with atrial fibrillation).
further level test results showed no difference in the rates of infection or Richter's transformation (CLL to another invasive lymphoma) in two groups of patients with level 3 and above.
the Calquence group OS (Total Lifetime) has a numerical benefit trend.
, Calquence's safety and tolerance are consistent with its previous clinical development projects.
ELEVATE-RR (ACE-CL-006) study is a randomized, multi-center, open-label Phase III study designed to assess the efficacy of CLL patients with high-risk characteristics (with 17p deficiency and/or 11q deficiency) that have been treated in the past for Calquence vs Ibtinie therapy.
533 subjects were randomly divided into 2 groups and treated with Calquence (100 mg, 2 times daily) or Ibdinib (420 mg, 1 time daily) until the disease progressed or beed irresopidable.
The main endpoint of the study was PFS (non-poor performance, 250 event test results) assessed by the Independent Review Board), the secondary endpoints included the rate of atrial fibrillation, the rate of infections associated with treatment-related level 3 and above, the conversion rate of Richter's, and total lifetime.
CLL is the most common type of leukemia in adults, with an estimated 114,000 new cases worldwide in 2017.
with the improvement of treatment methods, CLL patients' life expectancy increased significantly.
of bone marrow hematopoietic stem cells in the blood of CLL patients turned into abnormal lymphocytes that were difficult to resist infection.
with the increase in the number of abnormal cells, healthy white blood cells, red blood cells and plates have less and less room to live, leading to anemia, infection and bleeding.
activation of BTK signal is one of the important ways necessary for B cell proliferation, transport, adhesion and adhesion.
Calquence belongs to a new generation of BTK selective inhibitors that inhibit their activity by combining with BTK co-price.
Calquence was first approved in the U.S. in October 2017 for the treatment of sleeve cell lymphoma (MCL) and in November 2019, two new adaptations were approved in the U.S. for the treatment of CLL and small lymphocytic lymphoma (SLL).
November 2020, Calquence was approved in the European Union for the treatment of adult CLL.
2019 global sales of $164 million, according to the New Pharma database of the Rubik's Cube.
has not yet declared a listing in China. "After 40 months of follow-up, today's results confirm that the selective BTK inhibitor Calquence has shown superior safety in atrial fibrillation and is not inferior to Ibteni," said Jose Baselga, executive vice president of research and development at
Oncology.
data from this study leads us to believe that Calquence can bring more benefits to CLL patients.
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