Bristol Myers Squibb (BMS) announced on March 14th, 2024, that the FDA approved their CAR T-cell therapy product liso-cel (Breyanzi) for the treatment of CLL patients who have received at least two prior lines of treatment (including a BCL-2 inhibitor like venetoclax (Venclexta) and a BTK inhibitor like zanubrutinib [Brukinsa], acalabrutinib [Calquence], ibrutinib [Imbruvica], or pirtobrutinib [Jaypirca]). Liso-cel will be commercially available for CLL patients starting March 21st, 2024.
“CLL and SLL are currently considered incurable diseases with few treatment options in the relapsed setting that can confer complete responses, something that has historically been associated with improved long-term outcomes. The FDA approval of liso-cel in relapsed or refractory CLL and SLL after treatment with prior BTKi and BCL-2i is a remarkable breakthrough, shifting the treatment paradigm from continuous therapy with sequential regimens to overcome drug resistance, to a one-time personalized T-cell based approach that has the potential to offer patients complete and lasting remission” Dr. Tanya Siddiqi, Medical Director at the City of Hope National Medical Center (California).
In the TRANSCEND CLL 004 study, 20% of CLL patients achieved a full reduction of CLL signs and symptoms following one liso-cel infusion. At the checkpoint of 23.5 months, these patients continued to remain in remission.
Chimeric antigen receptor (CAR) T-cell therapy is a type of immunotherapy that helps the patient’s T cells become efficient at destroying the cancer. For some CLL patients, the one-time infusion has granted over a year of cancer-free remission.
“CAR T-cell therapies are customized for each individual patient. They are made by collecting T-cells from the patient and re-engineering them in the laboratory to produce proteins on their surface called chimeric antigen receptors, or CARs. The CARs recognize and bind to specific proteins, or antigens, on the surface of cancer cells” Cancer.gov.
Image source: Cancer.gov
In the case of liso-cel, it will take approximately 36 days from the request until the administration of the CAR-T cell therapy.
After the infusion, you may be monitored at the infusion center for a few days to review if side-effect treatment is needed. Some patients may experience the below side effects, however, most patients quickly recover with the help of in-clinic medicines.
In conclusion, the personalized and one-time CAR T-cell therapy infusion of liso-cel may provide relapsed/refractory CLL patients with long-term remission and manageable side effects.
Bristol Myers Squibb (BMS) announced on March 14th, 2024, that the FDA approved their CAR T-cell therapy product liso-cel (Breyanzi) for the treatment of CLL patients who have received at least two prior lines of treatment (including a BCL-2 inhibitor like venetoclax (Venclexta) and a BTK inhibitor like zanubrutinib [Brukinsa], acalabrutinib [Calquence], ibrutinib [Imbruvica], or pirtobrutinib [Jaypirca]). Liso-cel will be commercially available for CLL patients starting March 21st, 2024.
“CLL and SLL are currently considered incurable diseases with few treatment options in the relapsed setting that can confer complete responses, something that has historically been associated with improved long-term outcomes. The FDA approval of liso-cel in relapsed or refractory CLL and SLL after treatment with prior BTKi and BCL-2i is a remarkable breakthrough, shifting the treatment paradigm from continuous therapy with sequential regimens to overcome drug resistance, to a one-time personalized T-cell based approach that has the potential to offer patients complete and lasting remission” Dr. Tanya Siddiqi, Medical Director at the City of Hope National Medical Center (California).
In the TRANSCEND CLL 004 study, 20% of CLL patients achieved a full reduction of CLL signs and symptoms following one liso-cel infusion. At the checkpoint of 23.5 months, these patients continued to remain in remission.
Chimeric antigen receptor (CAR) T-cell therapy is a type of immunotherapy that helps the patient’s T cells become efficient at destroying the cancer. For some CLL patients, the one-time infusion has granted over a year of cancer-free remission.
“CAR T-cell therapies are customized for each individual patient. They are made by collecting T-cells from the patient and re-engineering them in the laboratory to produce proteins on their surface called chimeric antigen receptors, or CARs. The CARs recognize and bind to specific proteins, or antigens, on the surface of cancer cells” Cancer.gov.
Image source: Cancer.gov
In the case of liso-cel, it will take approximately 36 days from the request until the administration of the CAR-T cell therapy.
After the infusion, you may be monitored at the infusion center for a few days to review if side-effect treatment is needed. Some patients may experience the below side effects, however, most patients quickly recover with the help of in-clinic medicines.
In conclusion, the personalized and one-time CAR T-cell therapy infusion of liso-cel may provide relapsed/refractory CLL patients with long-term remission and manageable side effects.
about the author
Megan Heaps
Megan joined HealthTree in 2022. As a writer and the daughter of a blood cancer patient, she is dedicated to helping patients and their caregivers understand the various aspects of their disease. This understanding enables them to better advocate for themselves and improve their treatment outcomes. In her spare time, she enjoys spending time with her family.