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AZN trials placed on hold by FDA

07 September 2017 13:16

AstraZeneca and MedImmune, its global biologics research and development arm, have said they 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.

The trials placed on partial clinical hold are:

- 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

- 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

- MEDI4736-MM-005: A Phase II, multicenter, single-arm study to determine the efficacy for the combination of durvalumab plus daratumumab in patients with relapsed and refractory multiple myeloma that have progressed while on current treatment regimen containing daratumumab

- MEDI4736-NHL-001: A Phase I/II, open-label, multi-center study to assess the safety and tolerability of durvalumab as monotherapy and in combination therapy in subjects with lymphoma or chronic lymphocytic leukaemia. The only arm in this trial for which enrolment is suspended is the arm with the durvalumab, REVLIMID and rituximab combination

- MEDI4736-DLBCL-001: A Phase II, open-label, multicenter study to evaluate the safety and clinical activity of durvalumab in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) or with lenalidomide plus R-CHOP (R2 CHOP) in patients with previously untreated, high risk diffuse large B Cell lymphoma

The trial placed on full clinical hold is:

- MEDI4736-MM-002: A Phase Ib multicenter, open-label study to determine the recommended dose and regimen of durvalumab in combination with lenalidomide with and without low-dose dexamethasone in subjects with newly diagnosed multiple myeloma

At 1:15pm: (LON:AZN) AstraZeneca PLC share price was +89.25p at 4665.75p

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