Summit, NJ (Press Release) –  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.

Forward-Looking Statements

This press release con­tains forward-looking state­ments, which are generally state­ments that are not historical facts. Forward-looking state­ments can be identified by the words "expects," "antic­i­pates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar ex­pres­sions. Forward-looking state­ments are based on man­age­ment's current plans, esti­mates, assump­tions and projections, and speak only as of the date they are made. We under­take no obli­ga­tion to update any forward-looking state­ment in light of new in­­for­ma­tion or future events, except as other­wise required by law. Forward-looking state­ments involve in­her­ent risks and un­cer­tain­ties, most of which are dif­fi­cult to predict and are generally beyond our control. Actual results or out­comes may differ ma­teri­ally from those implied by the forward-looking state­ments as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Com­mis­sion.

Source: Celgene.