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 expected, the company said.
Further enrollments have been paused as the FDA investigates the deaths, as well as an unspecified number of low-grade events in connection with the drug trial. Meanwhile, participants who were already enrolled will continue to receive the investigational treatment.
“Patient safety is always at the forefront for us, and work is now underway to compile further analyses that may inform the FDA,” said Anna Protopapas, president and chief executive officer of Mersana Therapeutics.
According to a study conducted in 2019, the chance of death during clinical trials is rare. The study found that out of around 23,000 participants of 32 trials in Germany over a decade, 88 died. However, out of these deaths, only 27% were directly related to the treatment.
Clinical drug trials by 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. Photo by Science in HD on Unsplash