Risk of secondary cancers after CAR-T cell therapy just 6.5%

CAR-T therapy

A large study has found that the risk of secondary blood cancers after CAR-T cell therapy is low, despite the Food and Drug Administration (FDA) warning.

In November 2023, the FDA issued a warning about a risk of secondary cancers that may be associated with CAR-T cell therapy.

The warning was preceded by a rising tide of concern following reports of patients diagnosed with T cell cancers unrelated to the cancer for which they had been treated.

However, a study of over 700 patients treated at Stanford Health Care in the US indicates that the risk is low – around 6.5% in the three years after therapy.

In the only case of fatal secondary T cell cancer, researchers found it was likely due to the immunosuppression caused by CAR-T cell therapy, rather than the CAR-T cells.

“We wanted to understand this one rare case, so we analysed all the patients treated with CAR-T cell therapy at Stanford with wide breadth and studied this single case extraordinary depth,” said Professor of Medicine Ash Alizadeh, a member of the Stanford Cancer Institute.

“We compared protein levels, RNA sequences and DNA from single cells across multiple tissues and time points to determine that the therapy didn’t introduce the lymphoma into this patient; instead it was already brewing in their body at very low levels.”

The study may help researchers and clinicians identify prospective CAR-T cell therapy recipients who are at increased risk of secondary cancers.

“This study could serve as a blueprint for how to capture and characterise the outcomes of CAR-T therapies so we can develop a very clear understanding of their risks and benefits,” Alizadeh added. “The challenge lies in how to predict which patients are at higher risk, and why.”

Diana Spencer, Senior Digital Content Editor, DDW

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