Dr Choi on the Implications of Approving Liso-Cel in Patients With CLL


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Michael Choi, MD, discusses the potential FDA approval of lisocabtagene maraleucel in patients with relapsed/refractory chronic lymphocytic leukemia.

Michael Choi, MD, hematologist/medical oncologist, associate professor, medicine, Moores Cancer Center, University of California San Diego (UCSD) Health, discusses the potential FDA approval of lisocabtagene maraleucel (Breyanzi; liso-cel) for patients with relapsed/refractory chronic lymphocytic leukemia (CLL), citing why CAR T-cell therapy has been more difficult to integrate into the CLL treatment armamentarium compared with in other hematologic malignancies.

Choi begins by stating that many of his patients inquire about the potential approval of certain CAR T-cell therapies, such as liso-cel, for CLL. Notably, the FDA has granted priority review to the supplemental biologics license application seeking approval to expand the indication of liso-cel to include patients with relapsed/refractory CLL or small lymphocytic lymphoma. The desire for the approval of liso-cel for patients in this population is understandable, considering the proven efficacy of other CAR T-cell products in patients with CLL, he states. Choi states that the initial successes with CAR T-cell therapy in hematologic malignancies were observed in patients with CLL, some of whom remain in remission approximately 10 years after CAR T-cell infusion.

However, the lack of approvals of CAR T-cell therapies for patients with CLL patients stems from several factors, he notes.

Firstly, there's a heightened risk of toxicity associated with CAR T-cell treatment compared with BTK inhibitors, Choi expands. For many patients, this risk isn't deemed necessary unless indications of resistance to existing drugs emerge, according to Choi. Presently, CAR T-cell therapy may find its place in later lines of CLL therapy, he states, adding that there are still areas for improvement in CAR T-cell therapy's effectiveness. Patients with CLL exhibit immune system deficiencies that may differ from those of patients with other cancers, necessitating different disease management strategies, he elucidates.

Some studies have shown improved efficacy of CAR T-cell treatment when combined with ibrutinib (Imbruvica) or other BTK inhibitors, indicating a potential treatment strategy for patients with CLL, Choi continues. With each trial and advancement in CAR T-cell therapy, incremental enhancements are being achieved, he says. Hopefully, the CLL field will reach a stage where CAR T-cell therapy becomes a viable option for patients in need, Choi concludes.

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