Date: 2015-12-07
Type of information: Clinical research agreement
Compound: durvalumab (MEDI4736) in combination with pomalidomide
Company: Celgene (USA - NJ) AstraZeneca (UK)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism: monoclonal antibody. Durvalumab (MEDI4736) is a 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. This antibody is directed against B7-H1, have been shown to block the interaction between B7-H1 and its receptors, PD-1 and CD80 (B7-1). This blockade may help to overcome the immunosuppressive effects of B7-H1 on anti-tumor T cells.
Disease: hematological cancers including non-Hodgkin's lymphoma, myelodysplastic syndromes and multiple myeloma
Details: * On December 7, 2015, Celgene and AstraZeneca announced the initiation of the FUSION clinical development program of durvalumab (MEDI4736), an investigational human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1) in hematologic disorders. The FUSION program is part of a strategic collaboration with AstraZeneca to develop and commercialize durvalumab across a range of blood cancers including non-Hodgkin's lymphoma, myelodysplastic syndromes and multiple myeloma. The program will initially include four studies:
MM-001 - A phase 1b multicenter, open-label study to determine the recommended dose and regimen of durvalumab as a monotherapy or in combination with pomalidomide with or without low-dose dexamethasone in patients with relapsed/refractory multiple myeloma
CC-486-MDS-006 - A phase 2 international, multicenter, randomized, open-label, parallel-group study to evaluate the efficacy and safety of CC-486 alone or in combination with durvalumab in patients with MDS who fail to achieve an objective response to treatment with azacitidine for injection or decitabine
MEDI4736 -NHL-001 - A phase 1/2 open-label, multicenter study to assess the safety and tolerability of durvalumab as monotherapy and in combination therapy in patients with lymphoma or chronic lymphocytic leukemia
MEDI4736-MDS-001 - A randomized, multicenter, open-label phase 2 study evaluating the efficacy and safety of azacitidine subcutaneous in combination with durvalumab in previously untreated patients with higher-risk myelodysplastic syndromes or in elderly (? 65 years) acute myeloid leukemia subjects not eligible for hematopoietic stem cell transplantation
The Celgene partnership with AstraZeneca / MedImmune is part of a comprehensive commitment to immuno-oncology that includes not only clinical-stage checkpoint inhibitors and t-cell activators, but also earlier stage research efforts on the tumor microenvironment focused on tumor-associated macrophages, monocytes, natural killer cells and regulatory T cells.
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