Date: 2014-11-04
Type of information: Clinical research agreement
Compound: Imbruvica® (ibrutinib) and PI3 kinase pathway inhibitors
Company: AstraZeneca (UK) Pharmacyclics (USA - CA)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism: tyrosine kinase inhibitor/Bruton's tyrosine kinase inhibitor/monoclonal antibody/phosphoinositide 3-kinase (PI3K) inhibitor. Imbruvica® (ibrutinib) is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton's tyrosine kinase (BTK). BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells. Imbruvica® blocks signals that tell malignant B cells to multiply and spread uncontrollably. The drug received marketing authorisation from the European Commission in October 2014 for the treatment of adult patients with relapsed or refractory mantle cell lymphoma, or adult patients with chronic lymphocytic leukaemia who have received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
Disease: relapsed or refractory diffuse large B-cell lymphomas
Details: * On November 4, 2014, AstraZeneca and Pharmacyclics announced that they have entered into a clinical trial collaboration to evaluate novel combination therapies targeting a number of hematologic cancers. The collaboration will explore separate combinations of two different AstraZeneca investigational PI3 kinase pathway inhibitors in combination with Imbruvica® (ibrutinib), Pharmacyclics' oral Bruton's tyrosine kinase inhibitor, for the treatment of patients with relapsed or refractory Diffuse Large B-cell Lymphomas. Under the terms of the agreement, AstraZeneca and Pharmacyclics will collaborate on a non-exclusive basis and multiple studies may be considered and conducted. The studies will be led by AstraZeneca. The Phase I element of each study is expected to establish a recommended safe and tolerable dose and schedule for the combination, and the Phase IIa element will assess its safety and efficacy in an expanded patient population.The results of the clinical studies will be used to determine whether further clinical development of the different combinations is warranted.
Financial terms: Financial terms of the agreement have not been disclosed.
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