MSD forced to pause enrolment after Keytruda deaths
pharmafile | June 13, 2017 | News story | Manufacturing and Production, Research and Development |
MSD has been hit by a major surprise after an independent monitoring committee raised a warning after an imbalance in deaths in two on-going trials. What will be the bigger surprise – the warning or the first snippet of bad news for Keytruda in some time – remains to be seen but it means enrolment for the trials will have to stop.
The trials, Keynote-183 and Keynote-185, are Phase 3 study that sees Keytruda used alongside Celgene’s Imnovid and Revlimid, respectively, for the treatment of multiple myeloma.
Individuals in Keynote-183 had previously undergone two lines of prior treatment while those in Keynote-185 were ineligible for autologous stem cell transplant.
Multiple myeloma is a type of bone marrow cancer that has currently has no cure.
It is the first time that MSD has had to pause in its push for more indications for Keytruda – there are a number of on-going trials that Keytruda is being tested in and this particular news interrupts the flow of positive results.
MSD has not yet revealed any further details as to why the incidence of deaths may have occurred. It released a statement, reading: “The pause is to allow for additional information to be collected to better understand more reports of death in the Keytruda groups. Patients currently enrolled in these two studies will continue to receive treatment. Other studies of Keytruda continue unchanged.”
Keytruda is the major drug for MSD, with a predicted $3.59 billion expected to be generated in sales from the drug in this year alone. The latest news has caused a slight blip in MSD share price, as it fells by 1% on the news. Observers of the trial will have to wait until MSD is ready to release the details to find out exactly what happened to cause the imbalance in death in the studies.
Ben Hargreaves
