AstraZeneca and Celgene Corporation announced they will initiate the FUSION clinical development program of durvalumab (MEDI4736), an investigational human monoclonal antibody against the PDL1 immune checkpoint inhibitor, in hematologic diseases. The FUSION clinical program was announced at recent the 57th Annual Meeting of the American Society of Hematology, held in Orlando, Florida.
The FUSION clinical development program is part of a strategic partnership of AstraZeneca and MedImmune, the company’s global biologics research and development arm, to develop and commercialize durvalumab across a range of blood cancers, such as multiple myeloma, non-Hodgkin’s lymphoma, and myelodysplastic syndromes. Durvalumab is designed to counter a tumor’s immune-evading tactics by blocking PDL1, an immune checkpoint that helps cancer cells avoid detection.
The clinical development program will initially comprise four studies:
- MM-00, a Phase Ib trial to establish the recommended regimen and dose of durvalumab alone or used in combination with pomalidomide, with or without low-dose dexamethasone, in relapsed/refractory multiple myeloma patients.
- CC-486-MDS-006, a Phase 2 global, multicenter, randomized, open-label, parallel-group trial that will assess the safety and efficacy of CC-486 as monotherapy or in combination with durvalumab in patients with myelodysplastic syndromes who fail to attain an objective response with azacitidine for injection or decitabine.
- MEDI4736 -NHL-001, a Phase 1/2 multicenter, open-label clinical trial to evaluate the tolerability and safety of durvalumab alone and used as a combination therapy in lymphoma or chronic lymphocytic leukemia patients.
- MEDI4736-MDS-001, a Phase 2, multicenter, randomized, open-label clinical trial to assess safety and efficacy of azacitidine administered subcutaneously in combination with durvalumab in previously untreated patients at increased risk for myelodysplastic syndromes or in elderly (≥ 65 years) acute myeloid leukemia patients who are ineligible for hematopoietic stem cell transplantation.
“The initiation of the FUSION program represents an important step forward in Celgene’s development of immuno-oncology approaches in hematologic disease,” Robert Hershberg, MD, PhD, Celgene’s senior vice president, Immuno-Oncology, said in a recent press release. “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,” said 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.”