Celgene Provides Update on the Fusion™ Clinical Program
September 07 2017 - 7:30AM
Business Wire
Celgene Corporation (NASDAQ:CELG) today announced that the U.S.
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™ program. The trials are testing IMFINZI™
(durvalumab), an anti-PD-L1 antibody, in combination with
immunomodulatory and chemotherapy agents in blood cancers such as
multiple myeloma, chronic lymphocytic leukemia and lymphoma.
The decision by the FDA was based on risks identified in other
trials for an anti-PD-1 antibody, pembrolizumab, in patients with
multiple myeloma in combination with immunomodulatory agents. In
the FUSION™ program, 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.
Patients enrolled in the trials on partial clinical hold who are
receiving clinical benefit from treatment as determined by the
investigator, 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.
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 Subjects
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 Subjects 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 Subjects 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 Leukemia.
The only arm in this trial for which enrollment 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 Subjects 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
The trials that will continue to enroll are:
- MEDI4736-MDS-001: A Randomized,
Multicenter, Open-label, Phase II Study Evaluating the Efficacy and
Safety of Azacitidine Subcutaneous in Combination with Durvalumab
in Previously Untreated Subjects with Higher-Risk Myelodysplastic
Syndromes or in Elderly (>= 65 Years) Acute Myeloid Leukemia
Subjects Not Eligible for Hematopoietic Stem Cell
Transplantation
- CC-486-MDS-006: A Phase II,
International, Multicenter, Randomized, Open-label, Parallel Group
to Evaluate the Efficacy and Safety of CC-486 Alone in Combination
with Durvalumab in Subjects with Myelodysplastic Syndromes Who Fail
to Achieve an Objective Response to Treatment with Azacitidine for
Injection or Decitabine
In April 2015, Celgene entered into a strategic collaboration
with MedImmune, the global biologics research and development arm
of AstraZeneca, to develop and commercialize IMFINZI™ for
hematologic malignancies. The use of IMFINZI™ in combination with
other agents for the treatment of patients with hematologic
malignancies is not approved by the FDA, and the safety and
efficacy of those combinations have not been established.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical company engaged primarily in
the discovery, development and commercialization of innovative
therapies for the treatment of cancer and inflammatory diseases
through next-generation solutions in protein homeostasis,
immuno-oncology, epigenetics, immunology and neuro-inflammation.
For more information, please visit www.celgene.com. Follow Celgene
on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and
YouTube.
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Celgene CorporationPatrick E. Flanigan III,
908-673-9969Corporate VP, Investor RelationsorBrian Gill,
908-673-9530VP, Corporate Communications
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