Imbruvica is co-developed by Pharmacyclics and Janssen and commercialized outside the US by Janssen affiliates.
Janssen affiliates market Imbruvica in Europe, Middle East and Africa as well as the rest of the world, except for the US, where both companies co-market the drug.
The two-part trial, which will be conducted by Pharmacyclics, is designed to evaluate the combination as a treatment for patients with haematological cancers including diffuse large B-cell lymphoma and follicular lymphoma, which are investigational uses for both compounds.
The trial’s Phase I part is expected to establish a recommended dose regimen for the combination of MEDI4736 and ibrutinib, while the Phase IIa part will evaluate the safety and efficacy of the investigational combination.
MEDI4736 is an investigational human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1) and it blocks the signals that help tumors avoid detection by the immune system, countering the tumor’s immune-evading tactics.
While, ibrutinib blocks signals that tell malignant B cells to multiply and spread uncontrollably.
According to preclinical evidence, the combination of these two agents may lead to an improved anti-tumour immune response.
AstraZeneca executive vice-president of Global Medicines Development and chief medical officer Dr Briggs Morrison said: "We are committed to progressing our strong immuno-oncology pipeline as rapidly as possible.
"Our partnership with Pharmacyclics and Janssen supports our exploration of the potential of anti-PD-L1 in haematological cancers – an area of significant unmet need as many lymphoma patients still progress despite treatment.
"It is also further evidence of our belief that combination therapies have the potential to be one of the most effective ways of treating cancer."
Image: The trial will evaluate the efficacy and safety of AstraZeneca’s MEDI4736 in combination with Imbruvica. Photo: courtesy of Michelle Meiklejohn/ freedigitalphotos.net.