A clinical drug trial that the two companies are testing new cancer treatments individually has been put on hold after six participants, including a child, died, the report said.
The two trials are in different stages of testing. Seattle Children’s Therapeutics, in partnership with biotech company 2seventy Bio, was testing a treatment for a blood cancer called acute myeloid leukemia (AML), while drug company Mersana was in the final stages of testing a new drug for ovarian cancer when the deaths occurred, CNN Report.
The patient who died in Seattle Children’s Therapeutics’ phase 1 safety trial was their first participant to receive a higher dose of the study treatment. The therapy combines CAR T cells activated by the anticancer drug rapamycin. Three other patients in the study received lower doses.
“Our thoughts and hearts are with this family and what happened to their child. The field of pediatric oncology is small, and we entered it to find a cure for childhood cancer patients, and that’s what we’re all committed to Seattle Children’s So whenever something like this happens it can be devastating to the family and the team, noted Dr. Rebecca Gardner, the treatment center’s interim chief medical officer, adding that the study has been paused while the cause of death is investigated.
“The safety of every patient who participates in our studies or receives our therapies is our top priority, and we are in constant communication with the FDA as we evaluate the data on this SAE (serious adverse event) and possible next steps,” said 2seventy bio’s chief executive Medical Officer Dr Steve Bernstein said in a statement Press Releases.
Mersana was testing the drug upifitamab rilsodotin, or UpRi, before submitting it for FDA approval when five participants experienced fatal bleeding episodes. About 560 people have taken the drug so far, with a higher-than-expected rate of fatal bleeding events, the company said.
Further registrations have been put on hold as the FDA investigates the deaths and an unspecified number of low-grade events related to the drug trial. At the same time, participants who have already enrolled will continue to receive research treatment.
“Patient safety is always our top priority and work is currently underway to prepare further analyzes that may inform FDA,” explain Anna Protopapas, President and CEO, Mersana Therapeutics.
according to a study Conducted in 2019, the chances of dying during the clinical trial are rare. The study found 88 deaths among about 23,000 participants in 32 trials in Germany over the past 10 years. However, only 27% of these deaths were directly related to treatment.
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Published by Medicaldaily.com