AstraZeneca BTK inhibitor Acatini III clinically reached the main endpoint

ELEVATE-RR (ACE-CL-006) is a head-to-head randomized, multi-center, open Phase III non-poor clinical trial of Acatinib and Ibdinib for patients who have previously been treated with CLL and have high-risk characteristics (17p deficiency and/or 11q deficiency).
the trial was conducted in 533 patients (1:1) and randomly divided into two groups, Akatinib (100 mg, oral, twice daily) and Ibdinib (420 mg per day orally) until the disease progressed or becoming unacceptable toxicity.
The main endpoints of the trial were PFS assessed by an independent review board, and secondary endpoints included the rate of atrial fibrillation, the occurrence of therapeutic level 3 or higher infections, the occurrence of Richter transformation (CLL transition to invasive lymphoma) and the overall survival rate.
, ELEVATE-RR is the first Phase III clinical treatment to compare two BTK inhibitors to CLL head-to-head, according to AstraZenecon press release.
is the most common type of leukemia in adults.
In addition, it is worth mentioning that Baiji Shenzhou has also conducted two head-to-head Phase III clinical trials with Ibtinib for its BTK inhibitor Zebutinib, including Fahrenheit globulinemia (WM), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
previously released updated data from zebutinib vs. Ibtinib in the AsPEN Global Phase 3 head-to-head clinical trial in patients with WM at the 2020 ASCO online meeting on May 29, 2020.
results showed that at a medium follow-up time of 24.2 months, the total total and very good partial remission rates assessed by the researchers at a medium follow-up time of 24.2 months were 30.4% vs. Ibdinib (p-value: 0.03).
At the same time, Zebtini has significantly improved safety and tolerance compared to Ibdini, and the overall risk of adverse events (AE) is low, especially in adverse events requiring special attention, such as atrial fibrillation (Zebtini 3.0% vs. Ibtini 18.4%).
CLL/SLL is also an area of adaptation that Baiji attaches great importance to.
Two clinical studies, ALPINE against Ibdini and SEQUOIA against BR, are expected to publish clinical data in 2021, according to information previously presented at J.P. Morgan's annual conference on health care.