Treatment with Carvykti (ciltacabtagene autoleucel, also known as cilta-cel), has been shown to be effective among patients with relapsed or refractory multiple myeloma in a real-world setting, meaning in treating patients outside of a clinical trial.
Study findings published in Blood showed that 89% of patients responded to treatment and 70% experienced a complete response. This was among 236 patients who were treated with Carvykti at 16 United States academic medical centers who had received a median of six prior lines of therapy and 56% of whom wouldn’t have been eligible for the landmark CARTITUDE-1 clinical trial,
The Food and Drug Administration (FDA) approved Carvykti in 2022 for the treatment of adults with relapsed or refractory multiple myeloma who underwent four or more previous treatments based on the finding of the phase 2 CARTITUDE-1 clinical trial, in which 98% of patients with pretreated relapsed or refractory myeloma responded to treatment and, after one treatment, 78% of patients achieved a stringent complete response.
Glossary
Multiple myeloma: a blood cancer that develops in the plasma cells of the bone marrow, according to the Multiple Myeloma Research Foundation.
Complete response: the disappearance of cancer.
Progression-free survival: the time a patient lives without their disease spreading or worsening, When median progression-free survival is not reached in a study it means less than half of the patients have experienced disease progression.
Overall survival: the time a patient lives, regardless of disease status. When median overall survival is not reached in a study it means more than half of the patients are still alive.
Cytokine release syndrome: a condition associated with fever, nausea, headache, rash, rapid heartbeat, low blood pressure and trouble breathing, according to the National Cancer Institute.
Immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome: an emergent toxicity associated with life-threatening complications, according to research published in Transplant and Cellular Therapy.
At a median follow-up of 13 months from treatment, median progression-free survival was not reached, but the 12-month estimate was 68%. Likewise, the median overall survival was not reached, and the estimated 12-month overall survival rate among infused patients was 82%.
“Even though in the real world a majority of patients are not as fit in terms of performance status, organ function, or baseline blood counts as they were in the clinical trial that led to FDA approval [of this therapy], these patients can do very well,” said Dr. Surbhi Sidana, the study’s lead author and associate professor at Stanford University School of Medicine, in a news release. “We saw very high response rates that appeared to be durable, despite over half of the patients not meeting [the trial’s] eligibility criteria. The response rates and time until progression of myeloma or death due to any reason was within the range of results observed in the clinical trial.”
Regarding side effects, researchers reported that 75% of patients experienced cytokine release syndrome, with 5% experiencing grade 3 (severe) or worse events, including three grade 5 (fatal) events. Immune effector cell-associated neurotoxicity syndrome was experienced by 14% of patients, with 4% experiencing grade 3 or higher effects, and 10% of patients experiencing delayed neurotoxicity.
Researchers reported that of the 50 patients who had died, 23 experienced non-relapse mortality, including 12 deaths from infections, three from cytokine release syndrome, one from cytokine release syndrome and infection, three from delayed neurotoxicity, two from immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome and one each from immune effector cell-associated neurotoxicity syndrome and a second primary malignancy.
CAR-T cell therapy such as Carvykti, as explained by the National Cancer Institute, involves a patient’s T cells, part of the immune system, being extracted, changed in a laboratory to attack cancer cells, grown in the laboratory and infused back into the patient. Carvykti is currently approved by the FDA to be administered in the second line of treatment.
Reference
“Safety and Efficacy of Standard of Care Ciltacabtagene Autoleucel for Relapsed/Refractory Multiple Myeloma” by Dr. Surbhi Sidana, et al., Blood.
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