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Celgene and AZ update on Fusion trial programme
Celgene and AZ update on Fusion trial programme.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 1338Q AstraZeneca PLC 07 September 2017 \n\n \n7 September 2017 12:30 BST\n \n \nCELGENE AND ASTRAZENECA PROVIDE UPDATE\nON THE FUSION CLINICAL TRIAL PROGRAMME\n \nAstraZeneca and MedImmune, its global biologics research and development arm, have been informed by partner Celgene that the US Food and Drug Administration (FDA) has placed a partial clinical hold on five trials and a full clinical hold on one trial in the Celgene FUSION programme. The trials are testing Imfinzi (durvalumab), an anti-PD-L1 agent, in combination with immunomodulatory agents, with or without chemotherapy, in blood cancers such as multiple myeloma, chronic lymphocytic leukaemia and lymphoma.\n \nThe decision by the FDA was based on risks identified in other trials for an anti-PD-1 agent, pembrolizumab, in patients with multiple myeloma in combination with immunomodulatory agents. No imbalance has been observed in the FUSION programme; however, the clinical holds allow for additional information to be collected to further understand the risk benefit profile of the programme. The FDA has taken similar action with other combination trials in patients with multiple myeloma. \n \nPatients enrolled in the trials on partial clinical hold who are receiving clinical benefit from treatment may remain on treatment. Patients enrolled in the trial on full clinical hold will be discontinued from treatment. No new patients will be enrolled into the listed trials. \n \nOther trials with Imfinzi in haematological malignancies and other tumour types continue unchanged.\n \nThe trials placed on partial clinical hold are:\n \n· MEDI4736-MM-001: A Phase Ib multicenter, open-label study to determine the recommended dose and regimen of durvalumab either as monotherapy or in combination with pomalidomide with or without low-dose dexamethasone in patients with relapsed and refractory multiple myeloma\n· MEDI4736-MM-003: A Phase II, multicenter, open-label study to determine the safety and efficacy for the combination of durvalumab and daratumumab in patients with relapsed and refractory multiple myeloma\n· MEDI4736-MM-005: A Phase II, multicenter, single-arm study to determine the efficacy for the combination...