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ACE-LY-004 phase II trial results substantiate established efficacy and safety profile of Calquence in mantle cell lymphoma.- AstraZeneca.

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Last updated:20th Dec 2021
Published:7th Dec 2020
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). 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. AEs in the trial remained largely unchanged with an additional year of follow up. The most frequent AEs of any grade (greater than or equal to 20% of patients) included headache (39%), diarrhoea (37%), fatigue (30%), cough (23%), myalgia (22%) and nausea (22%), and were primarily Grade 1/2. Grade 3/4 AEs included neutropenia (11%), anaemia (10%) and pneumonia (6%). Overall, 16 patients (13%) had cardiac AEs (11 with prior cardiac risk factors), with three of the 16 cardiac AEs occurring in the last year of follow up (two were Grade 3/4). Overall, six patients (5%) had Grade 3/4 cardiac AEs. One patient had Grade 3/4 hypertension in the last year (total any grade, n=5 [4%]; total Grade 3/4, n=2 [2%]), and five patients had bleeding AEs in the last year (total any grade, n=46 [37%]). Three patients had Grade 3/4 infections in the last year.
Condition: Mantle Cell Lymphoma
Type: drug

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