Study Finds CAR-T Therapy Doesn't Increase Second Cancer Risk

A recent study conducted by researchers at the Memorial Sloan Kettering Cancer Center (MSKC) in New York City offers new insights into the safety of CAR-T cancer therapies. Contrary to existing warnings on CAR-T therapy labels, the study suggests that these treatments do not increase the risk of developing secondary cancers. This finding may prompt a reevaluation of current warning labels, which could potentially reassure patients considering this form of treatment.

CAR-T therapy involves modifying T-cells from a patient's blood to include a gene for a receptor known as a chimeric antigen receptor (CAR). These altered T-cells are then reintroduced into the patient's body to target and destroy specific cancer cells. According to the American Cancer Society, this treatment can be particularly effective for certain cancers, especially when other treatments have failed.

Despite the promising potential of CAR-T therapies, the U.S. Food and Drug Administration (FDA) issued a boxed warning in January. The warning suggested that CAR-T therapies might increase the risk of secondary T-cell cancers, unrelated to the B-cell lymphoma or multiple myeloma for which the CAR-T was initially administered. This warning was based on data from the FDA's Adverse Event Reporting System.

Dr. Kai Rejeski, the lead author of the new study and a research fellow at MSKC, argues that the FDA's data may not adequately account for other risk factors such as patient age, previous treatments, and the duration of follow-up. He emphasizes the importance of understanding these potential risks but also cautions against overinterpreting the data in a way that could unduly alarm patients.

The new study analyzed data from 18 clinical trials and seven real-world studies, encompassing over 5,500 patients with lymphoma or multiple myelomas. These patients received one of six currently approved CAR-T cell therapies. During a median follow-up period of nearly 22 months, 326 secondary cancers were observed, equating to about 5.8% of patients developing new malignancies.

Four trials specifically compared the outcomes of patients receiving CAR-T therapy to those on standard treatment regimens. The rates of secondary cancers were similar across both groups, with 5% of CAR-T patients developing new tumors compared to 4.9% of those who did not receive CAR-T therapy. The study also found that the risk of secondary cancers was not influenced by the type of cancer being treated or the specific CAR-T therapy used.

Interestingly, patients who had undergone more than three courses of non-CAR-T treatments before receiving CAR-T therapy showed a higher risk for secondary cancers. However, the majority of new malignancies observed were not T-cell specific. Only five cases (0.09%) were T-cell malignancies, and genetic testing indicated that just one of these was related to the CAR-T therapy.

Dr. Rejeski pointed out that the success of CAR-T therapies in extending patient lifespans might inadvertently increase the likelihood of developing new cancers over time. He strongly advises against withholding CAR-T therapy due to the negligible risk of T-cell malignancies, highlighting that it is the first treatment in over two decades to show a significant survival benefit for patients with refractory large B-cell lymphoma.

The findings of the study were published on September 11 in Clinical Cancer Research. This research underscores the need for a balanced view of the risks and benefits associated with CAR-T therapies, potentially leading to revised warning labels that better reflect the actual risk profile.

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