Clinicians call for closer monitoring of patients post CAR T therapy

Australian clinicians are raising questions about whether cancer patients need closer monitoring after receiving CAR T-cell therapy.

A Peter MacCallum Cancer Centre study, which examined patients from the phase 3 CARTITUDE-4 trial, funded by Johnson & Johnson Innovative Medicine (formerly Janssen), identified a rare but serious side effect of Carvykti CAR T-cell therapy – secondary blood cancer – in patients treated for relapsed or refractory multiple myeloma.

Professor Simon Harrison, Director of the Centre of Excellence for Cellular Immunotherapy at Peter Mac, described these cases as a “newly identified class-wide safety signal” for CAR T-cell therapy, urging a reassessment of post-treatment monitoring protocols.

“These cases of secondary blood cancer are rare and have occurred in less than 1% of patients who received CAR T-cell therapy,” Professor Harrison explained. “CAR-T therapy has proven to be highly effective in the treatment of blood cancer with the benefits of this therapy continuing to far outweigh any risk to patients with multiple myeloma. However, vigilant monitoring is required to keep watch for this secondary cancer in the longer term.”

The CARTITUDE-4 trial compared Johnson & Johnson’s Carvykti to standard of care (daratumumab, pomalidomide, and dexamethasone, or pomalidomide, bortezomib, and dexamethasone). At 30 months, overall survival (OS) rates were 76.4% for Carvykti and 63.8% for standard care (p=0.0009), while progression-free survival (PFS) rates stood at 59.4% and 25.7%, respectively (p<0.0001).

Two patients – one in Australia and one in France – who received Carvykti as part of the trial later developed secondary T-cell lymphoma between 5 and 16 months after treatment.

Using advanced genomic technologies, researchers at Peter Mac, the Wilson Centre for Blood Cancer Genomics, and the Collaborative Centre for Genomic Cancer Medicine traced the origins of the lymphoma, revealing that it arose within a CAR T-cell and originated from cells present in the patients years earlier.

Associate Professor Piers Blombery, Clinical and Laboratory Haematologist and Lead of the Molecular Haematology Service at Peter Mac, highlighted the significance of these findings. He stated, “The use of novel genomic techniques to investigate the lymphoma cells in these patients has let us understand where they are coming from, how to detect them at earlier stages, and ultimately how to avoid them.”

Despite the secondary blood cancer diagnosis, both patients responded well to further treatment for T-cell lymphoma, and their multiple myeloma has remained controlled.

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