SUMMIT, N.J.—Celgene Corporation, along with AstraZeneca, has announced the launch of the FUSION clinical development program of durvalumab (MEDI4736), an investigational human monoclonal antibody targeting programmed cell death ligand 1 (PD-L1) in hematologic disorders. This program is part of a strategic collaboration with AstraZeneca and MedImmune, its global biologics research and development arm, for the development and commercialization of durvalumab in a variety of blood cancers, including non-Hodgkin's lymphoma, myelodysplastic syndromes and multiple myeloma. The partnership between Celgene, AstraZeneca and MedImmune is part of a comprehensive commitment to immuno-oncology, and includes clinical-stage checkpoint inhibitors and T cell activators as well as earlier-stage research efforts into the tumor microenvironment focused on tumor-associated macrophages, monocytes, natural killer cells and regulatory T cells.
"The initiation of the FUSION program represents an important step forward in Celgene's development of immuno-oncology approaches in hematologic disease," Dr. Robert Hershberg, senior vice president of Immuno-Oncology for Celgene, remarked in a statement. "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.”
The FUSION program will initially consist of four studies. MM-001 will be 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 will be a Phase 2 international, multicenter, randomized, open-label, parallel-group study focused on the efficacy and safety of CC-486 alone or in combination with durvalumab in patients with myelodysplastic syndrome 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, will evaluate the safety and tolerability of durvalumab as monotherapy and in combination therapy in patients with lymphoma or chronic lymphocytic leukemia. And MEDI4736-MDS-001, a randomized, multicenter, open-label Phase 2 study, will assess the safety and efficacy of azacitidine subcutaneous in combination with durvalumab in previously untreated patients with higher-risk myelodysplastic syndromes or in elderly acute myeloid leukemia subjects (older than 65 years) who aren't eligible for hematopoietic stem cell transplantation.
"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 and head of Immuno-oncology, Global Medicines Development at AstraZeneca, commented in a press release. "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."
SOURCE: Celgene press release
