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AstraZeneca's Calquence (acalabrutinib) Demonstrates Activity in Relapsed or Refractory Mantle Cell Lymphoma TrialAstraZeneca and Acerta Pharma, its haematology research and development centre of excellence, today presented results from the open-label, single-arm Phase II ACE-LY-004 clinical trial, which served as the basis for the recent US Food and Drug Administration (FDA) accelerated approval of Calquence (acalabrutinib). The findings were presented for the first time during an oral session at the 59th American Society of Hematology (ASH) Annual Meeting & Exhibition in Atlanta, USA and demonstrate the safety profile and efficacy of acalabrutinib in the management of previously-treated mantle cell lymphoma (MCL (News - Alert)). Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "The results presented for the first time to the medical community highlight the potential of Calquence as a treatment for people with relapsed or refractory mantle cell lymphoma, a life-threatening form of blood cancer. These data reinforce the important progress of our clinical development programme as well as our commitment to advancing the treatment of patients with blood cancers." 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 MCL clinical trial, said: "Most people living with mantle cell lymphoma will unfortunately relapse, and new treatment options are greatly needed. As shown by the consistent overall response rates observed in this trial across several pre-specified subgroups, acalabrutinib is a welcome new treatment option for certain patients with this aggressive blood cancer." Summary of key investigator-assessed efficacy results from ACE-LY-004 (15.2 months median follow-up):
The overall response rate was consistent across multiple subgroups including age, tumour burden and number or type of prior treatments. The secondary endpoint of median duration of response had not yet been reached at 15.2 months median follow-up. The median time-to-response, an exploratory endpoint, was 1.9 months. After 12 months of treatment, 72% (95% CI: 62,80) of patients were still responding to acalabrutinib treatment. The secondary endpoints of progression-free survival and overall survival had not yet been reached; at 12 months, the progression-free survival and overall survival rates were 67% (95% CI: 58,75) and 87% (95% CI: 79,92), respectively. In this trial, the most common non-haematological adverse reactions (reported in =20% of patients at a median follow-up time of 15.2 months) were headache (38%), diarrhoea (30%), fatigue (26%) and myalgia (21%), per investigator assessment. Grade 3 or 4 adverse reactions (=5%) included anaemia (12%), neutropenia (11%), and pneumonia (6%). Calquence was granted accelerated approval by the US FDA in October 2017 for the treatment of adult patients with MCL who have received at least one prior therapy. This indication is approved based on overall response rate, and continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. - ENDS - NOTES TO EDITORS
About Calquence (acalabrutinib) Calquence was granted accelerated approval by the US Food and Drug Administration (FDA) in October 2017 for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Acalabrutinib is not approved for use outside of its labelled indication in the US and is not approved in any other country at this time. Acalabrutinib is also in development for the treatment of multiple B-cell malignancies and other blood cancers including 1st-line MCL, chronic lymphocytic leukaemia (CLL), Waldenström macroglobulinaemia (WM), follicular lymphoma, diffuse large B-cell lymphoma, and multiple myeloma. It is also being developed as a monotherapy and in combination trials for solid tumours. More than 35 clinical trials across 40 countries with more than 2,500 patients are underway or have been completed.5 Acalabrutinib was granted Orphan Drug Designation by the European Commission in March 2016 and the US FDA in 2015 for the treatment of patients with CLL, MCL and WM, and Breakthrough Therapy Designation in August 2017 by the US FDA for the treatment of patients with MCL who have received at least one prior therapy.
About Mantle Cell Lymphoma (MCL)
About the ACE-LY-004 Trial
About AstraZeneca in Oncology By harnessing the power of four scientific platforms - Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates - and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.
About Acerta Pharma
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