US-based biopharmaceutical firm Celgene and British drugmaker AstraZeneca have started the Fusion clinical development programme of durvalumab (MEDI4736), an investigational human monoclonal antibody, directed against programmed cell death ligand 1 (PD-L1) in haematologic disorders.
The programme is part of a strategic collaboration between AstraZeneca and its worldwide biologics research and development unit MedImmune.
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Fusion is aimed at developing and commercialising durvalumab across a range of blood cancers, including non-Hodgkin’s lymphoma, myelodysplastic syndromes and multiple myeloma.
Four studies will initially be carried out under the programme and they will evaluate durvalumab and combination therapies in several haematologic disorders.
The companies will conduct a Phase Ib multi-centre, open-label study (MM-001) 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.
A Phase II international, multi-centre, randomised, open-label, parallel-group study (CC-486-MDS-006) will 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.
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By GlobalDataAn open-label, multi-centre Phase I/II study (MEDI4736 -NHL-001) is designed to evaluate the safety and tolerability of durvalumab as monotherapy and in combination therapy in patients with lymphoma or chronic lymphocytic leukaemia.
In a randomised, multi-centre, open-label Phase II study (MEDI4736-MDS-001), the companies will evaluate the efficacy and safety of azacitidine subcutaneous in combination with durvalumab in previously untreated patients with higher-risk myelodysplastic syndromes or in elderly acute myeloid leukaemia subjects not eligible for haematopoietic stem cell transplantation.
Celgene immuno-oncology senior vice-president Robert Hershberg said: "The initiation of the Fusion programme represents an important step forward in Celgene’s development of immuno-oncology approaches in haematologic disease.
"Checkpoint inhibitors hold tremendous promise in the treatment of cancer and we believe Celgene’s deep experience in haematology allows us unique perspective on this growing area of clinical research."
The Celgene collaboration with AstraZeneca is part of its commitment to immuno-oncology that includes clinical-stage checkpoint inhibitors and t-cell activators, and earlier stage research efforts.
Blocking signals from PD-L1, Durvalumab has not been approved for any use.
