AstraZeneca, along with Acerta Pharma, its haematology research and development centre of excellence, and MedImmune, its global biologics research and development arm, will highlight significant progress in blood cancer research at the 59th 2017 American Society of Hematology (ASH) Annual Meeting & Exhibition in Atlanta, USA. Presentations will include new data from AstraZeneca’s emerging haematology portfolio in several cancer types including mantle cell lymphoma (MCL), chronic lymphocytic leukaemia (CLL), hairy cell leukaemia (HCL), acute myeloid leukaemia (AML), multiple myeloma and diffuse large B-cell lymphoma (DLBCL).
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “Following the recent accelerated approval of AstraZeneca’s first medicine for a blood cancer, Calquence, we will share a broad range of new data at ASH highlighting our scientific progress in haematology as we seek to develop potential medicines that advance patient care.”
Efficacy and safety of Calquence in the management of previously-treated MCL
Following the US Food and Drug Administration (FDA) accelerated approval of Calquence (acalabrutinib), a kinase inhibitor indicated for the treatment of adult patients with MCL who have received at least one prior therapy, data from the pivotal Phase II ACE-LY-004 clinical trial on which the accelerated approval was based, will be presented for the first time (Abstract #155). New details of the trial will be shared, including median time to response, pre-specified patient subgroup efficacy analyses, as well as safety analyses, further characterising the clinical profile of Calquence in this patient population.
Calquence as monotherapy and in combination in multiple CLL patient populations
Results will be presented from the Phase Ib/II ACE-CL-003 trial evaluating Calquence and obinutuzumab in treatment-naïve and previously-treated CLL patients (Abstract #432), which highlight the safety profile and activity of the combination. Long-term follow-up safety and efficacy data from the Phase I/II ACE-CL-001 clinical trial which tested Calquence as a monotherapy in a large cohort of patients with relapsed or refractory CLL (Abstract #498) will expand on findings previously reported; these data will highlight the favourable duration of response in this patient population.
Early-stage haematology portfolio
- AstraZeneca will present additional data from its haematology portfolio, including findings from a Phase I trial of moxetumomab pasudotox, an anti-CD22 recombinant immunotoxin and potential new medicine in development for the treatment of people with previously-treated HCL (Abstract: #2765)
- Early data on AZD2811, a novel nanoparticle inhibitor of aurora kinase B being tested in AML (Abstract #1368)
- Preclinical data from trials on MEDI2228, a BCMA-targeting pyrrolobenzodiazepine-linked antibody drug conjugate being tested in multiple myeloma (Abstract #3153)
- Data from a trial of vistusertib (AZD2014), a dual mTORC1/2 inhibitor being tested in DLBCL (Abstract #4113).