AstraZenecas ACE-LY-004 Phase II Trial Of Calquence Shows Long-term Efficacy And Tolerability At 3-years For Patients With Relapsed Or Refractory Mant

Long-term follow-up results from the positive ACE-LY-004 phase II trial showed patients with relapsed or refractory mantle cell lymphoma (MCL) treated with Calquence (acalabrutinib) remained progression free for a median of 22 months, with median overall survival not yet reached at three years of follow-up. The safety and tolerability profile remained consistent. These results were presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition on 6 December 2020.MCL is typically an aggressive, rare form of non-Hodgkin lymphoma (NHL) that accounts for nearly 6% of all NHL cases and is mostly found in males during their early sixties.At a median follow up of 38.1 months (range: 0.3-59.5), 55 patients (44%) either remained on treatment (24 patients) or continued to be followed for survival (31 patients). The safety profile remained largely unchanged from the last analysis at 26 months, with only 14 patients (11%) having discontinued treatment due to adverse events (AE).Michael L. Wang, MD, Professor, Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, and principal investigator of the ACE-LY-004 phase II trial said, “Mantle cell lymphoma is an aggressive, difficult-to-treat blood cancer that is typically diagnosed at an advanced stage and often becomes resistant to treatment. This data shows that patients treated with acalabrutinib experienced deep responses over time, while the safety profile remained largely the same, including low rates of grade 3/4 events, cardiac events and bleeding events, which are important in this patient population.”José Baselga, executive vice president, Oncology R&D said, “These results add to the mounting evidence that Calquence can provide sustained responses in patients over more than three years. Calquence is an important chemo-free treatment option for relapsed or refractory mantle cell lymphoma and is rapidly being embraced across the clinical and patient community.”Additionally, an exploratory analysis of 30 patients meeting the criteria for minimal residual disease (MRD) evaluation showed six patients (20%) achieved a complete response and undetectable MRD (uMRD) and maintained uMRD at last assessment.Mantle cell lymphoma (MCL) is an uncommon type of B-cell non-Hodgkin lymphoma. MCL comprises 3% to 6% of non-Hodgkin lymphomas, with an annual incidence of 0.5 per 100,000 population in Western countries; in the US, it was estimated that approximately 3,300 new cases of MCL were diagnosed in 2016. The median age at diagnosis is 68 years, with MCL occurring more often in men than women. While MCL patients initially respond to treatment, there is a high relapse rate.ACE-LY-004 is an open-label, single-arm phase II clinical trial evaluating Calquence in adult patients with relapsed or refractory MCL. Adults with MCL and ECOG PS =2 who had relapsed or were refractory to 1-5 prior therapies, had no prior BTK/BCL-2 inhibitor exposure, and did not require warfarin/vitamin K antagonists, received oral Calquence 100mg twice-daily until progressive disease or toxicity. Overall response rate (investigator-assessed partial response or better per Lugano classification), duration of response, progression-free survival, overall survival, and safety were assessed. Minimal residual disease was analysed in formalin-fixed, paraffin-embedded samples and peripheral blood by next-generation sequencing (5x10-6) in patients with available paired samples.Calquence (acalabrutinib) is a next-generation, selective inhibitor of Bruton’s tyrosine kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting its activity. In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.Calquence is approved for the treatment of chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma in the US and is approved for CLL in the EU and several other countries worldwide. Calquence is also approved for the treatment of adult patients with MCL who have received at least one prior therapy in the US and several other countries. Calquence is not currently approved for the treatment of MCL in Europe.

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