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Celgene says US FDA places holds on clinical trials for cancer checkpoint inhibitor being developed with AstraZeneca

Last updated: 08:46 07 Sep 2017 EDT, First published: 03:46 07 Sep 2017 EDT

Cancer cells
In pre-market New York trading, after an initial drop, Celgene shares steadied around 0.3% lower at US$139

Celgene Corp. (NASDAQ:CELG) saw its shares ease in pre-market trading after the drug company said that the US Food and Drug Administration has placed a partial clinical hold on five clinical trials and a full clinical hold on one other trial for its durvalumab anti-PD-L1 antibody.

The NASDAQ-listed company has been developing and commercialising durvalumab - part of a class of cancer drugs called checkpoint inhibitors - for hematologic malignancies in partnership with UK drugs giant AstraZeneca (LON:AZN).

Celegene said the FDA's decision was due to risks seen in other trials for another checkpoint inhibitor, Merck & Co.'s (NYSE:MRK) anti-PD-1 antibody pembrolizumab, in combination with immunomodulatory agents.

The group said, for the trials on partial clinical holds, patients who are benefiting from treatment can stay on the therapy.

In the trial with a full clinical hold -- which is testing a durvalumab combination in multiple myeloma -- patients will be discontinued from treatment.

No new patients will be enrolled in any of the six trials, which are in multiple myeloma, lymphoma or chronic lymphocytic leukemia and large B cell lymphoma.

Two mid-stage trials with durvalumab, one in myelodysplastic syndromes or in elderly acute myeloid Leukemia and the other in myelodysplastic syndromes, will continue to enroll, Celgene said.

In pre-market New York trading, after an initial drop, Celgene shares steadied around 0.3% lower at US$139, while in London, AstraZeneca pushed higher, up 2.2% to 4,675.5p supported by other positive news on drug trials today. 

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