On November 4, 2014 AstraZeneca and Pharmacyclics reported that they have entered into clinical trial collaborations to evaluate novel combination therapies targeting solid tumours and a number of haematological cancers (Press release AstraZeneca, NOV 4, 2014, View Source;astrazeneca-and-pharmacyclics-enter-clinical-trial-collaborations-oncology [SID:1234500963]).
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The first collaboration, focusing on solid tumours, will evaluate the efficacy and safety of IMBRUVICA (ibrutinib), Pharmacyclics’ oral Bruton’s tyrosine kinase inhibitor in combination with AstraZeneca’s anti-PD-L1 antibody, MEDI4736.
The second collaboration will focus on haematological cancers and will explore separate combinations of two different AstraZeneca investigational PI3 kinase pathway inhibitors with IMBRUVICA, for the treatment of patients with relapsed or refractory diffuse large B-cell lymphomas. Preclinical evidence suggests that the combination of IMBRUVICA with these investigational medicines may enhance their effects.
Under the terms of the agreements, AstraZeneca and Pharmacyclics will collaborate on a non-exclusive basis and multiple Phase I and Phase IIa studies may be considered and conducted. The studies focused on solid tumours will be led by Pharmacyclics, while AstraZeneca will lead those exploring haematological cancers. 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 financial terms of the agreement have not been disclosed. The results of the clinical studies will be used to determine whether further clinical development of the different combinations is warranted.
Susan Galbraith, Head of AstraZeneca’s Oncology Innovative Medicines Unit said: "There is a clear and significant unmet need in the treatment of haematological malignancies, an area of increasing focus for AstraZeneca. Our partnership with Pharmacyclics will allow us to explore new and potentially potent treatment combinations, which could have a positive impact on patient outcomes."
"We are optimistic that combining our oral once-per-day IMBRUVICA with other agents has the potential to enhance efficacy and duration across the landscape of haematological cancers," said Bob Duggan, Chairman & CEO, Pharmacyclics. "In addition, we are extremely interested in the potential for IMBRUVICA in combination with an anti-PD-L1 antibody to improve the treatment of solid tumours in patients who need better therapeutic options."