FDA Orders 6 Partial or Full Clinical Holds on Celgene's Blood Cancer Studies

Published: Sep 08, 2017

FDA Orders 6 Partial or Full Clinical Holds on Celgene's Blood Cancer Studies September 7, 2017
By Mark Terry, BioSpace.com Breaking News Staff

Summit, NJ – The U.S. Food and Drug Administration (FDA) placed a partial clinical hold on five of Celgene Corporation ’s clinical trials and a full clinical hold on one of its clinical trials in its FUSION program. The trials all are studying Imfinzi (durvalumab), an anti-PD-L1 antibody, in combination with other immune and chemotherapeutic drugs in blood cancers. What is a bit unusual is that the holds aren’t specific to Celgene’s products, but related to risks associated with other clinical trials of Merck & Co. ’s Keytruda (pembrolizumab) in combination with immunomodulatory agents.

Celgene states, “the Company has not discerned, at this time, an imbalance in the risk benefit profile; however, the clinical holds allow for additional information to be collected to further understand the risk benefit profile of the program.”

In April 2015, Celgene teamed up with MedImmune , the research-and-development division of AstraZeneca to develop and commercialize Imfinzi for hematologic cancers.

Patients in the trials with the partial clinical hold will be able to stay on the program if the investigator determines they are receiving clinical benefit. Patients in the trial with the full clinical hold will be taken off treatment. No new patients will be added at this time.

The trial with the full clinical hold is MEDI4736-MM-002, a Phase Ib study to evaluate the recommended dose and regimen of durvalumab in combination with lenalidomide with and without low-dose dexamethasone in patients with newly diagnosed multiple myeloma.

Two other trials will continue to enroll patients. The first is MEDI4736-MDS-001, a Phase II trial of azacitidine subcutaneous in combination with durvalumab in previously untreated patients with higher-risk myelodysplastic syndrome in elderly acute myeloid leukemia patients who aren’t eligible for hematopoietic stem cell transplant. The second is CC-486-MDS-006, a Phase II trial of CC-486 in combination with durvalumab in patients with myelodysplastic syndromes who fail to achieve an objective response to azacitidine for injection or decitabine.

The five clinical trials that were placed on partial clinical hold are:

• MEDI4736-MM-001: A Phase Ib trial 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 trial to study the combination of durvalumab and daratumumab in patients with relapsed and refractory multiple myeloma.

• MEDI47736-MM-005: A Phase II trial of the combination of durvalumab and daratumumab in patients with relapsed and refractory multiple myeloma that have progressed while receiving treatments with daratumumab.

• MEDI4736-NHL-001: A Phase I/II trial of durvalumab as monotherapy and in combination therapy in patients with lymphoma or chronic lymphocytic leukemia. The only part of this trial that was placed on partial clinical hold is the arm with the combination of durvalumab, Revlimid and rituximab.

• MEDI4736-DLBCL-001: A Phase II trial of durvalumab in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) or with lenalidomide plus R-CHOP in patients with previously untreated, high-risk diffuse large B cell lymphoma.

Celgene is down slightly at the news, currently trading for $140.28.

Back to news