The two patients who passed away died from swelling of the brain, which occurred after the chemotherapy agent fludarbine was added to the treatment program. Doctors began to see an increase in "severe neurotoxicity," said CEO Hans Bishop.
"The last week has been difficult and humbling for everyone involved, in particular, of course, the physicians and the patients' families," Bishop added, according to the AP.
This prompted the US Food and Drug Administration (FDA) to temporarily shut down the CAR-T therapy program known as JCAR015.
A similar death was reported in May, but both the FDA and Juno said there were "compounding factors."
The therapy works by looking to extract immune system T cells from a patient, then alter their DNA to help spot and eliminate cancer cells in the person's body. The modified cells are then returned to the patient.
"This sort of thing is incredibly common in new drug development. It's unfortunate, but I don't know how you avoid it," Dr Otis Brawley, chief medical officer for the American Cancer Society, told AP.
Comment: The business of modern cancer treatment: Modern cancer care is not set up to treat you, an individual. Their primary goal is to validate experimental therapies for future cancer patients many years down the road. Due to regulatory red tape, drug-company greed, failures in the scientific process and lack of a universal will to do what's best for each and every patient, modern cancer care fails an unacceptable percentage of the time.
Those enrolling in the program normally receive doses of chemotherapy before receiving the CAR-T therapies as this makes the cancerous tumor more vulnerable to the CAR-T cell. The experimental medicines can cause the buildup of toxic debris from the killed-off tumor cells and this can damage healthy tissue. This inflammation is normally controlled through the use of steroids.
A researcher working on the study says more than 300 patients have been treated with similar therapies in the US without suffering any unwanted side effects. There were 20 patients on the JCAR015 program, and hopes of raising this to 90. Juno Therapeutics is now seeking FDA permission to continue the program without fludarbine.
"These are relatively rare events, so I don't think it changes the fundamental promise or the long-term plan here," said Dr Jae Park of Memorial Sloan Kettering Cancer Center in New York, AP reports.
Comment: 97 Percent of the time, chemotherapy does not work! Bigpharma greed and profits assure it's continued use, despite more effective and less toxic alternatives:
Cancer treatment is a very lucrative business; the only reason doctors prescribe chemotherapy is because they make money from it. Chemotherapy kills far more normal cells than cancer cells, and damages and toxifies many of the normal cells that do survive. It boosts cancer growth and long-term mortality rates. Most chemotherapy patients either die or are plagued with illness within 10-15 years after treatment. The treatment destroys their immune system, increases neuro-cognitive decline, disrupts endocrine functioning and causes organ and metabolic toxicities. People who refuse chemotherapy live over 12 years longer than those undergoing chemotherapy treatments, proving that there are effective treatment alternatives: