Clinical drug trials of two companies that were conducting separate testing for new cancer therapies have been put on hold after six of the participants, including one child died, reports said.
The two trials were in different stages of testing. Seattle Children’s Therapeutics, in conjunction with biotech company 2seventy Bio, was testing a treatment for a type of blood cancer called acute myeloid leukemia (AML), while the drug company Mersana was in the final stages of testing a new agent targeting ovarian cancer when the deaths occurred, CNN reported.
The patient who died in the Seattle Children’s Therapeutics’ phase one safety trial was their first participant to take a higher dose of the study therapy. The therapy combined CAR T-cells that were turned on by the anti-cancer drug rapamycin. Three other patients involved in the study were given a lower dosage of the therapy.
“Our thoughts and hearts go out to this family and what happened to their child. The field of pediatric oncology is small, and we go into it to figure out ways to cure patients of their childhood cancers, and that’s what we’re all dedicated to doing. So anytime something like this happens, it’s devastating for the family and the team,” noted Dr. Rebecca Gardner, interim chief medical officer at Seattle Children’s Therapeutics, adding the study has been paused while the death is being investigated.
“The safety of every patient who participates in our studies or is treated with our therapies is the utmost priority for us, and we are in communication with FDA while we assess the data surrounding this SAE [serious adverse event], and the potential next steps for the study,” Dr. Steve Bernstein, chief medical officer at 2seventy bio, said in a news release.
Mersana was testing the drug upifitamab rilsodotin, or UpRi, before presenting it for FDA approval when five participants had fatal bleeding events. About 560 people have so far taken the drug, and the rate of fatal bleeding events is higher than…
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