AstraZeneca and Celgene Corporation recently announced they will initiate the FUSION clinical development program for investigational anti-PDL1 immune checkpoint inhibitor durvalumab (MEDI4736) in hematologic disorders, including lymphoma. The announcement was made at the 57th Annual Meeting of the American Society of Hematology, held in Orlando, Florida.
Durvalumab is designed to counter tumors’ immune-evading tactics by blocking an immune checkpoint signal, PDL1, that helps cancer cells avoid detection. The FUSION clinical development program is part of a strategic partnership of AstraZeneca and MedImmune, the global biologics research and development arm of the Company, for the development and commercialization of durvalumab across a range of blood cancers, such as multiple myeloma, non-Hodgkin’s lymphoma and myelodysplastic syndromes.
FUSION will initially comprise four clinical trials:
- 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 patients with relapsed/refractory multiple myeloma.
- CC-486-MDS-006, a phase 2 global, multicentre, randomized, open-label, parallel-group trial that will examine the safety and efficacy of CC-486 alone or combined with durvalumab in myelodysplastic syndrome patients who fail to attain an objective response with azacitidine for injection or decitabine.
- MEDI4736 -NHL-001, a phase 1/2 multicentre, open-label clinical trial to evaluate tolerability and safety of durvalumab alone and used in combination therapy in lymphoma or chronic lymphocytic leukemia patients.
- MEDI4736-MDS-001, a phase 2, multicentre, randomized, open-label clinical trial to assess safety and efficacy of azacitidine given subcutaneously combined with durvalumab in patients who were previously untreated 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, M.D., Ph.D., Celgene’s Senior Vice President, Immuno-Oncology said in a 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,” added 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 tumor 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.”