AstraZeneca's BTK Inhibitor Calquence Reduces Risk of Disease Progression or Death by 71% in Relapsed/Refractory CLL at Three-Year Follow-Up
Dec 14, 2021 01:40
CST Updated
01:40
AstraZeneca
Biopharmaceutical Manufacturer
Chronic Lymphocytic Leukemia (CLL, Image Source: dxline.info)
December 13, 2021 /BioValleyBIOON/ --AstraZeneca(AstraZeneca) recently presented the latest results of the ASCEND Phase 3 trial at the 63rd American Society of Hematology (ASH) Annual Meeting in 2021. The data showed that in relapsed or refractory chronic lymphocyticLeukemiaIn adult patients with R/R CLL, compared with the investigator's choice of rituximab + idelalisib (IdR) regimen or rituximab + bendamustine (BR) regimen, its targeted anticancer drugBTK Inhibitor Calquence (Acalabrutinib) Maintains Statistically Significant Progression-Free Survival (PFS) Benefit Over Three Years of Treatment.
CLL is the most common type of leukemia in adults, and Calquence is a BTK inhibitor.. Data presented at ASH show that, during the 3-year treatment period,Compared with the IdR/BR regimen, Calquence significantly reduced the risk of disease progression or death by 71%.(HR=0.29; 95% CI: 0.21-0.41; p<0.0001). In exploratory analyses, similar clinical benefits were observed when each regimen was compared with Calquence. The safety and tolerability of Calquence were consistent with earlier study findings, with no new safety signals identified.
ASCEND Study 3-Year Follow-Up Data (Click Image to Enlarge)
The safety analysis from the head-to-head ELEVATE-RR Phase 3 trial was also presented at the ASH meeting to further describe treatment-related adverse events for the two BTK inhibitors, Calquence and Imbruvica (ibrutinib). Overall,Compared with the Calquence treatment group, the burden of any-grade adverse events experienced by patients in the Imbruvica treatment group was 37% higher. For any-grade atrial fibrillation/flutter (a key secondary endpoint in the ELEVATE-RR trial), the median time to onset was later with Calquence compared to Imbruvica, and the cumulative incidence at all time points from 6 months to 2 years was lower.
In addition, the ELEVATE-RR Phase 3 trial showed,The incidence of all-grade atrial fibrillation/flutter with Calquence was low across age, prior lines of therapy, and in patients without a history of prior cardiac complications.Atrial fibrillation is an irregular heart rate that can increase the risk of stroke, heart failure, and other heart-related complications.
"ELEVATE-RR trial Chief Investigator, Dr. John F. Seymour of the Royal Melbourne Hospital, stated: 'Patients with relapsed or refractory CLL face limited options for successfully treating their disease, as they are often older and suffer from significant comorbidities. The risk of cardiac adverse events is an important consideration, particularly when using BTK inhibitors, because in some cases they can lead to considerable morbidity and also result in treatment discontinuation. The ELEVATE-RR trial data provides compelling evidence that Calquence is a more tolerable option with reduced cardiovascular toxicity, which will give clinicians further confidence when prescribing this drug, knowing that fewer patients will need to discontinue treatment due to adverse events, thereby maintaining ongoing control of their disease, even in such complex circumstances.'"
Anas Younes, Senior Vice President of Hematology R&D at AstraZeneca, stated: "These impressive new long-term data support Calquence as the preferred treatment option for the most common type of adult leukemia (CLL), demonstrating favorable safety compared to the current standard of care. The overall data from the ASCEND and ELEVATE-RR trials continue to reinforce the positive experience that Calquence can bring to the CLL patient population."
Calquence was approved by the United States in October 2017.FDAAccelerated approval for marketing, indications include: (1) for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least one prior therapy; (2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
The active pharmaceutical ingredient in Calquence is acalabrutinib, a next-generation, highly selective, potent, covalent Bruton's tyrosine kinase (BTK) inhibitor that works by permanently binding to and inhibiting BTK.BTK is a key regulator of the B-cell receptor (BCR) signaling pathway, widely expressed in various types of hematologic malignancies, and involved in the proliferation, trafficking, chemotaxis, and adhesion of B cells, making it a therapeutic target for hematologic malignancies.TumorAn important target. In preclinical studies, acalabrutinib exhibited minimal off-target effects.
Currently, Calquence is being developed for multiple B-cell blood cancers, including CLL, MCL, diffuse large B-cell lymphoma (DLBCL), Waldenstrom macroglobulinemia (WM), follicular lymphoma (FL), multiple myeloma, and other hematologic malignancies.Tumor。
Calquence has the same mechanism of action as AbbVie/Janssen's blockbuster blood cancer drug Imbruvica (ibrutinib).The latter is the world's first approved BTK inhibitor. Since its initial approval in November 2013, Imbruvica has so far been approved for up to 11 treatment indications across six disease areas, with global sales steadily increasing. (Bioon.com)