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FDA places partial, full clinical holds on durvalumab trials for hematologic malignancies

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The FDA placed a partial clinical hold on five trials and a full clinical hold on one trial, all designed to evaluate durvalumab in combination with immunomodulatory and chemotherapy agents for the treatment of hematologic malignancies.

The agency based its decision on identified in trials evaluating pembrolizumab (Keytruda, Merck) in combination with immunomodulatory agents for the treatment of patients with multiple myeloma.

Celgene has not determined an imbalance in the risk-benefit profile associated with its FUSION program — designed to evaluate durvalumab (Imfinzi, AstraZeneca) — but the clinical holds allow for additional information to be collected to further understand the risk-benefit profile of the program.

Among the trials placed on partial clinical hold, patients who have demonstrated clinical benefit from treatment may continue receiving durvalumab regimens.

Patients enrolled in the trial placed on full clinical hold will be discontinued from treatment.

No new patients will be enrolled into durvalumab trials.

Trials placed on partial clinical hold include:

• the multicenter, open-label phase 1b MEDI4736-MM-001 trial designed to determine the recommended dose regimen for durvalumab monotherapy and in combination with pomalidomide (Pomalyst, Celgene) — with or without low-dose dexamethasone — in patients with relapsed and refractory multiple myeloma;
• the multicenter, open-label phase 2 MEDI4736-MM-003 trial designed to evaluate the efficacy and safety of durvalumab in combination with daratumumab (Darzalex, Janssen) in patients with relapsed and refractory multiple myeloma;
• the multicenter, single-arm phase 2 MEDI4736-MM-005 trial designed to investigate the efficacy and safety of durvalumab in combination with daratumumab in patients with relapsed or refractory multiple myeloma who have progressed on a treatment regimen with daratumumab;
• the multicenter, open-label phase 1/phase 2 MEDI4736-NHL-001 trial designed to assess the safety and tolerability of durvalumab monotherapy and in combination regimens for the treatment of patients with lymphoma or chronic lymphocytic leukemia; and
• the multicenter, open-label MEDI4736-DLBCL-001 trial designed to evaluate the safety and clinical activity of durvalumab in combination with R-CHOP or with lenalidomide (Revlimid, Celgene) plus R-CHOP in patients with previously untreated, high-risk, diffuse large B cell lymphoma.

The multicenter, open-label phase 1b MEDI4736-MM-002 trial — designed to determine the recommended dose and regimen of durvalumab in combination with lenalidomide, with and without low-dose dexamethasone, in patients with newly diagnosed multiple myeloma — is placed on full clinical hold.