Celgene Corporation, an integrated global biopharmaceutical company, and AstraZeneca, a global, science-led biopharmaceutical business, announced the initiation of the FUSION clinical development programme of durvalumab (MEDI4736), an investigational human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1) in hematologic disorders.

The FUSION programme is part of a strategic collaboration with AstraZeneca and its global biologics research and development arm MedImmune, to develop and commercialise durvalumab across a range of blood cancers including non-Hodgkin’s lymphoma, myelodysplastic syndromes and multiple myeloma.

The programme 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 initiation of the FUSION programme represents an important step forward in Celgene’s development of immuno-oncology approaches in hematologic disease,” said Robert Hershberg, M.D., Ph.D., Celgene’s senior vice president, immuno-oncology.

“Checkpoint inhibitors hold tremendous promise in the treatment of cancer and we believe Celgene’s deep experience in hematology allows us unique perspective on this growing area of clinical research.”

“We're pleased with the rapid start of the first clinical trials in the FUSION development program through our strategic partnership with Celgene,” Robert Iannone, senior vice president, head of immuno-oncology, global medicines development at AstraZeneca.

“Durvalumab is a highly promising investigational immunotherapy for a range of tumour types and we look forward to exploring its potential as a PD-L1 inhibitor for patients with blood cancers, for whom current treatment choices are limited."

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 tumour microenvironment focused on tumor-associated macrophages, monocytes, natural killer cells and regulatory T cells.

Durvalumab is an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. Durvalumab blocks these signals, countering the tumour's immune-evading tactics. Durvalumab is being investigated in an extensive clinical trial programme, as monotherapy or in combination in multiple cancer types.