Johnson & Johnson and Legend Biotech’s Carvykti shows improved survival in treatment-experienced multiple myeloma patients

1. As a 2^nd line therapy for multiple myeloma, Carvykti can lower the risk of disease progression or death by 59% versus standard therapies
2. Due to risks of cytokine release syndrome and neurological toxicities, patients using Carvykti should be monitored closely for high fever and altered mental status.

The Latest

Johnson & Johnson and Legend Biotech’s phase 3 CARTITUDE-4 trial showed that its multiple myeloma treatment Carvykti had statically significant and clinically meaningful overall survival when compared to standard combination therapies in multiple myeloma patients who had tried one to three prior lines of therapy. Prior to the release of the results from CARTITUDE-4, Carvykti had been approved by the FDA based on its ability to lower the risk of disease progression or death by 59% versus standard therapies. Despite its success, due to the risk of cytokine release syndrome and neurological toxicities, Carvykti is only available through the FDA’s risk evaluation and mitigation strategies program (REMS)

Physician’s Perspective

Multiple myeloma is a blood cancer that comes from plasma cells in bone marrow. Although multiple myeloma can be caused by genetic mutations, it is not thought to be a hereditary disease as the mutations that cause multiple myeloma develop spontaneously as people age. The 5-year relative survival rate of multiple myeloma patients diagnosed between 2014 and 2020 was 61.1%. As a 2^nd line therapy, Carvykti would potentially be able to improve the survival rate as shown in their phase-3 clinical trial where Carvykti was linked to a premature 43% reduction in the risk of death. For physicians, this would mean being able to present patients another viable option should first line therapies fail. Physicians and patients should monitor for serious side effects such as high fever, dizziness, blood clotting and altered mental status as the side effects of Carvykti have been reported to potentially cause death.

Molecular Target of Therapy

Carvytki is a therapy known as chimeric antigen receptor-T cell (CAR-T) therapy. The process works by first collecting the patient’s own white blood cells in a process known as leukapheresis. Over the next 4-5 weeks at a manufacturing site, the patient’s T-cells are genetically modified to recognize a protein on plasma cells known as B-cell maturation antigen (BCMA). BCMA is found at low levels in healthy patients but is elevated in patients with multiple myeloma making it an ideal target for immunotherapy. The newly genetically modified T-cells are then infused back into the patient to target the multiple myeloma cells.

Company History

Johnson & Johnson (J&J) is one of America’s oldest and largest pharmaceutical companies established in 1886. J&J’s drug pipeline and therapeutic interests are vast and extensive ranging from HIV to psoriasis. In contrast, Legend Biotech was founded in 2014 as an early-stage cell therapy company. Since its partnership with Johnson & Johnson in 2017, Legend Biotech has been focused on the development of Carvykti and will continue to build its drug pipeline based on research for chimeric antigen-receptor T-cells (CAR-T)

Further Reading: https://clinicaltrials.gov/study/NCT04181827

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