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FDA shutters MSD’s Keytruda combination trials in myeloma

Published on 06/07/17 at 02:59pm

Following on from the news last month that enrolment for Keytruda being used alongside Celgene’s Imnovid and Revlimid would have to be stopped, comes the complete halt called to three trials involving Keytruda.

MSD is unused to such bad news for a product that has, until recently, gone from strength to strength – garnering an ever-growing roster of indications in solid tumour types. However, a halt has been called to the two trials involving Celgene’s products, Keynote-183 and Keynote-185, as well as a further third trial, Keynote-023 Cohort 1, that saw patients treated with Keytruda alongside Revlimid and dexamethasone.

The halt was called after patients were found to have a higher incidence of death in comparison with the control arms. As yet, there have been no details revealed pointing towards why these combinations seem to increase risk for patients.

The news is damaging for the company, though it hastened to point out that the halt is for only three trials out of many on-going trials. The potentially troublesome suggestion would be if other PD-1/PD-L1 immunotherapy competitors are able to begin snagging combination therapy successes ahead of the company – a potential possibility with most now exploring the potential of enhancing the efficacy of their treatments. The news saw MSD’s shares drop by 1%.

“Patient safety is MSD’s primary concern, and we are grateful to the study investigators and patients involved in these studies for their commitment to this important research,” said Dr. Roger M. Perlmutter, President, MSD Research Laboratories. “MSD’s development program for Keytruda, spanning more than 30 different tumour types, has one priority: helping patients suffering from cancer.”

The halt means that in all trials mentioned, patients will no longer be able to continue with the medication regimen they were on previously.

Ben Hargreaves

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