Back in November of 2023, the US Food and Drug Association (FDA) issued a warning about the potential risks of secondary cancer occurrences, particularly blood cancers, that may be associated in patients who have undergone CAR-T cell therapies.
Its warning read, “FDA Investigating Serious Risk of T-cell Malignancy Following BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies.”
However, a recent, and large study conducted by Stanford Medicine, at Stanford Health Care, has shown the risk of secondary cancers associated with CAR-T cell therapies may, in fact, be quite low.
The study of over 700 patients revealed that the risk of secondary cancers, after three years of therapy, is about 6.5%. Further, the only fatal secondary cancer researchers found was in a patient that likely suffered immunosuppression caused by the therapy, but not by the CAR-T cells themselves.
In this case, according to Stanford Medicine, “The compromised immune systems allowed pre-existing, but not previously detected, cancer cells to grow explosively in the patient.”
Of the roughly 6.5% of patients who did have a secondary occurrence of cancer, analysis found there was no evidence that T cells responsible for the secondary cancer were those engineered for the CAR-T cell therapy.
Dr. Wee Kiat Tan, co-CEO of CytoMed Therapeutics (NASDAQ: GDTC), said of the Stanford study, “The long term follow-up study of patient who received CAR-T treatment has shown that it is relatively safe long term, and has not led to very significant cancer risk.”
Further, Dr. Tan said, “CytoMed employs non-viral, non-gene integrating methods to equip our gamma delta T cells with a CAR. Since there is no gene integration, the genome is unchanged which further decrease the chances of secondary cancers.”
Read more about the Stanford Medicine study, HERE
Or, see CytoMed Therapeutics’ latest investor presentation, HERE