CARVYKTI® (ciltacabtagene autoleucel) is a treatment used for adult patients who have cancer of the bone marrow called multiple myeloma. It is used when at least one other treatment has not worked or has stopped working. CARVYKTI® is a medicine made from your own white blood cells, which have been changed (genetically modified) to recognize and attack your multiple myeloma cells.
The TRIAL looked at HOW safe and effective CARVYKTI was compared with standard treatments
In a clinical study of 419 people with relapsed or refractory multiple myeloma, 208 were treated with CARVYKTI and 211 were treated with 1 of 2 types of standard multiple myeloma therapy.*
To participate in the trial, people had to meet certain guidelines:
They had been treated with at least 1 other course of treatment. The prior treatment included 2 types of medicines: a proteasome inhibitorProteasome inhibitor:Drug that stops cancer cell growth. Proteasome inhibitors include: bortezomib, carfilzomib, and ixazomib. and an immunomodulatory agentImmunomodulatory agent:Drug that stimulates or suppresses the immune system. Immunomodulatory agents include: thalidomide, lenalidomide, and pomalidomide. and they had not responded to lenalidomideLenalidomide:A type of immunomodulatory agent. before their symptoms returned or their disease stopped responding to treatment
People could not join the study if they had already tried a CAR-T or other BCMABCMA (B-cell maturation antigen):A special marker found on multiple myeloma cells. CARVYKTI finds this marker and uses it to attack the cancer.-targeting therapy, if their multiple myeloma had spread to their brain or spinal cord, or if they had neurologicNeurologic:Affecting the brain or nerves. conditions like Parkinson's disease
People on CARVYKTI in the trial lived longer without their disease progressing OR PASSING AWAY than those on standard therapies
One way clinical trials measure the effectiveness of therapy is through something called progression-free survival (PFS), which is the length of time during and after treatment that the patient lives with the disease but it doesn't get worse.
For people receiving CARVYKTI at 15.9 months, there was a 59% reduction of risk of their multiple myeloma getting worse or of passing away when compared with those receiving 1 of 2 standard therapy combinations
At 1 year:
who took CARVYKTI were living without their disease worsening or passing away
compared to
who took 1 of 2 standard therapy combinations were living without their disease worsening or passing away
*Standard therapy was either a combination of daratumumab, pomalidomide, and dexamethasone or a combination of pomalidomide, bortezomib, and dexamethasone.
†MedianMedian: The middle value in a set of numbers when they are arranged in order. It separates the higher half from the lower half of the data. For example, in the set {1, 2, 3, 4, 5}, the median is 3. follow-up was 33.6 months in the Intent-to-Treat Analysis Set.