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AstraZeneca's Calquence (acalabrutinib) Shows Potential in Chronic Lymphocytic Leukaemia TrialsAstraZeneca and Acerta Pharma, its haematology research and development centre of excellence, today presented results from the Phase Ib/II ACE-CL-003 clinical trial (Abstract #432) and updated results from the Phase I/II ACE-CL-001 (Abstract #498) clinical trial that are testing Calquence (acalabrutinib) alone and in combination for the treatment of chronic lymphocytic leukaemia (CLL) in multiple treatment settings. The findings were presented during two oral sessions at the 59th American Society of Hematology (ASH) Annual Meeting & Exhibition in Atlanta, USA. Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "These data add to the growing body of evidence that supports the potential of Calquence in the treatment of chronic lymphocytic leukaemia, a life-threatening disease that affects tens of thousands of people around the world. These emerging clinical data underscore AstraZeneca's commitment to advancing the science of blood cancer treatments." Jennifer Woyach, MD, Associate Professor of Internal Medicine, Division of Hematology, The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, said: "Despite treatment advances for chronic lymphocytic leukaemia in recent years, the urgent need for additional treatment options remains. The overall response rates observed in the acalabrutinib trials and presented at ASH highlight the potential impact that this investigational treatment could have on the management of CLL."
New, early acalabrutinib data from ACE-CL-003
combination therapy trial Across both cohorts in the trial, the most common adverse reactions (=25%) of any grade were upper respiratory tract infection (69%), maculopapular rash (64%), increased weight (64%), diarrhoea (62%), cough (58%), nausea (51%), headache (47%), infusion-related reaction (42%), contusion (42%), dizziness (42%), arthralgia (40%), vomiting (40%), constipation (38%), hypertension (38%), skin lesion (38%), fatigue (36%), peripheral oedema (36%), decreased appetite (33%), sinusitis (33%), fall (31%), myalgia (31%), oral pain (31%), dyspepsia (27%) and paraesthesia (27%). One patient with relapsed or refractory CLL who had a history of atrial fibrillation experienced intermittent atrial fibrillation (Grade 3), which was not considered treatment related and did not lead to treatment discontinuation.
Updated acalabrutinib monotherapy efficacy and safety from ACE-CL-001
trial These latest findings from the trial highlight the overall response rate and duration of response in this patient population. With a median time on study and follow-up of 24.5 months, overall response was 87% (95% CI: 80,92) and the overall response including partial response with lymphocytosis (increase in number of lymphocytes in the blood) was 93% (95% CI: 88,97); median duration of response was not reached. The complete response was 4% (3 patients). The median progression-free survival, a secondary endpoint in the trial, was not yet reached; however, based on the Kaplan-Meier estimate, the progression-free survival rate at 18 months was 90% (95% CI: 83,94). In this trial, the most common adverse reactions (=20%) of any grade were diarrhoea (48%), headache (47%), upper respiratory tract infection (31%), fatigue (28%), nausea (26%), cough (24%), arthralgia (25%), pyrexia (23%), contusion (23%), weight increased (21%), petechiae (21%) and constipation (20%). Grade =3 adverse reactions (=5% of patients) were neutropoenia (12%) and pneumonia (11%). 22% of patients discontinued treatment. The Phase I/II CLL clinical trial (ACE-CL-003 and ACE-CL-001) findings are part of an extensive development programme for acalabrutinib in a range of blood cancers, which includes three ongoing Phase III clinical trials (ACE-CL-006, ACE-CL-007 and ACE-CL-309) in patients with CLL. - 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 (News - Alert)) 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 in development for the treatment of multiple B-cell malignancies and other cancers including CLL, MCL, Waldenström macroglobulinaemia, follicular lymphoma, diffuse large B-cell lymphoma, and multiple myeloma. It is also being studied as a monotherapy and in combination trials for the treatment of solid tumours. More than 35 clinical trials across 40 countries with more than 2,500 patients are underway or have completed.7 Acalabrutinib was granted Orphan Drug Designation by the European Commission in March 2016 and by 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 Chronic Lymphocytic Leukaemia
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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