Date: 2014-11-04
Type of information: Clinical research agreement
Compound: MEDI4736 and Imbruvica® (ibrutinib)
Company: AstraZeneca (UK) Janssen Research & Development - J&J (USA - NJ) Pharmacyclics (USA - CA)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism: monoclonal antibody/immune checkpoint inhibitor/tyrosine kinase inhibitor/Bruton's tyrosine kinase 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. MEDI4736 is an investigational human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics. MEDI4736 is being developed, alongside other immunotherapies, to empower the patient’s immune system and attack the cancer. MEDI4736 is in development as monotherapy in solid tumours. It is currently in Phase III development for patients with non-small cell lung cancer and clinical trials are due to commence in 2014 for patients with squamous cell carcinoma of the head and neck. AstraZeneca and MedImmune, its biologics research and development arm, also have a broad programme of immuno-oncology combination trials underway, including MEDI4736 + tremelimumab (CTLA-4), MEDI4736 + MEDI0680 (PD-1), MEDI4736 + MEDI6469 (OX40) and MEDI4736 + IRESSA (epidermal growth factor receptor-tyrosine kinase inhibitor).
Disease: haematological cancers including diffuse large B-cell lymphoma and follicular lymphoma
Details: * On November 4, 2014, AstraZeneca, Pharmacyclics and Janssen Research & Development announced that they have entered into a clinical trial collaboration to evaluate the efficacy and safety of AstraZeneca’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Imbruvica® (ibrutinib), an oral Bruton’s tyrosine kinase inhibitor, co-developed by Pharmacyclics and Janssen and commercialised outside the US by Janssen affiliates. The study will assess 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 Phase I part of the trial is expected to establish a recommended dose regimen for the combination of MEDI4736 and ibrutinib, and the Phase IIa part of the trial will assess the safety and efficacy of the investigational combination. Under the terms of the agreement, the two-part trial will be conducted by Pharmacyclics.
Financial terms: The financial terms of the agreement have not been disclosed.
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