United States regulators put on hold the Juno Therapeutics trial after other two of the twenty patients have passed away. The trial treats advanced leukemia patients with a new oncology technique called CAR-T immunotherapy.
In May, three Juno patients died for the excess of fluids in their brains, according to reports made at the trial to the Food and Drug Administration (FDA), yet at the moment neither the FDA or researchers could determine if the trial had affected the cause of death.
Initially, the trial was expecting 90 patients suffering from advanced acute lymphoblastic leukemia, but only 20 enrolled in the study and were receiving CAR-T treatment.
Two months after the first deaths, two patients passed away under the same circumstances. They were all in their 20s. This caused the FDA to put the trial on hold, and the study can no longer receive more patients to get the treatment.
The study aims to modify patient’s immune cells to fight cancer. The procedure is called JCAR015 and works by harvesting the patient’s immune cells and modifying them to reject cancer cells in the blood system.
“Events like those in the last week are difficult and humbling for everyone involved,” said Juno’s CEO Hans Bishop in a call with Scientific American.
Fludarabine in the treatment
Researchers said that the deaths are a result of putting fludarabine to the chemotherapy administered to patients before receiving CAR-T therapy. The drug is used by trial specialists to wipe the patient from existing immune cells, so the treatment works better without troubles.
Bishop has affirmed the deaths can lead to question the trial and the safety of the patient’s receiving CAR-T cells. Conclusions shouldn’t be made until further investigations provide results on the cause of death.
The fludarabine drug wasn’t used when the trial first begun, yet the drug was administered in other immunotherapy treatments and researchers obtained outstanding results. The Juno trial decided to add the drug to the chemotherapy sessions.
Juno executives were hoping to get FDA approval as early as 2018, yet the hold on the trial sessions could mean a setback on the treatment and questioning from the general public. Executives have proposed the FDA to continue the trial without the fludarabine drug.
The trial’s share price has downgraded since the death were announced, almost in a 30 percent at the first hours of the announcement. As well as competition’s trials have also lowered in considerable manners.
No response from the FDA has confirmed whether the trial will be accepting new patients or if it would just stick to the current patients receiving treatment.
Source: Scientific American