AstraZeneca is joining up with Pharmacyclics and Janssen to hopefully improve clinical outcomes in a number of hematologic cancers.
The companies are planning
to conduct combination therapies using two different AstraZeneca investigational PI3 kinase pathway inhibitors with Pharmacyclics/Janssen’s approved Imbruvica®
(ibrutinib), a oral Bruton's tyrosine kinase inhibitor. The first cancer they will likely test will be relapsed or refractory diffuse large B-cell lymphomas.
The studies will be led by AstraZeneca.
Preclinical evidence suggests that the combination of Imbruvica with the two P13 kinase pathway inhibitors may enhance their effects.
Initially, a phase I study for each combination will be conducted to establish a safe and tolerable dose schedule. Following that, the phase IIa studies will assess their safety and efficacy in an expanded patient population.
Susan Galbraith, Head of AstraZeneca’s Oncology Innovative Medicines Unit said:
“There is a clear and significant unmet need in the treatment of hematological 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.”
Bob Duggan, Chairman & CEO, Pharmacyclics added:
“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 hematological cancers.”
The companies are also planning
to conduct another series of clinical trials investigation the combination of Imbruvica with AstraZeneca’s anti-programed cell death ligand (PD-L1) immune checkpoint inhibitor, MEDI4736 in solid tumors.
Imbruvica is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton's tyrosine kinase (BTK). It is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics.
Imbruvica is indicated to treat people with a number of rare hematologic cancers, including:
Chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.
Chronic lymphocytic leukemia (CLL) with 17p deletion (a genetic mutation that occurs when part of chromosome 17 has been lost).
Mantle cell lymphoma (MCL) who have received at least one prior therapy