2024-10-04 14:00:03
A chimeric antigen receptor (CAR)-T therapy for multiple myeloma, cilta-cel, has been shown to be as effective in the real world as it has been in clinical trials. This was seen in research published in the journal ‘Blood‘ carried out on more than 200 patients, some of whom would not have participated in previous clinical trials with this drug because they did not meet the necessary conditions.
The difference between a clinical study and the real world clinic is that the former is a controlled study with rigorous criteria and specific conditions to evaluate a treatment, while real-world clinical practice occurs in a less controlled environment, with more diverse patients and multiple variables that influence the treatment, reflecting how it works in everyday conditions. This means that in the first case the results are more homogeneous, while in the second, sometimes, they do not always corroborate the results of clinical studies.
In the work now presented, of 236 patients who received cilta-cel infusions at 16 U.S. medical centers in 2022, 89% saw their cancer respond to treatment and 70% had a complete response, meaning no there was detectable cancer after treatment.
These figures are comparable to the results of the phase II study CARTITUDE-1 which led to the approval of cilta-cel by the US Food and Drug Administration (FDA) and from European Medicines Agency (EMA), which showed a response rate of 98% and a complete response rate of 83%. ANDn Spain is not yet approved.
The most relevant thing, according to the researchers, was that More than half of the patients included in the new study would have been ineligible to participate in CARTITUDE-1.
“Although in the real world, most patients are not as fit in terms of performance status, organ function, or baseline blood counts as in the clinical trial that led to FDA approval [de esta terapia]“These patients can do very well,” said Surbhi Sidana, principal investigator of the study and associate professor at the University Stanford University School of Medicine.
Multiple myeloma is a cancer that affects plasma cells, a type of white blood cell.. Currently, about 40% of people diagnosed with multiple myeloma do not survive five years, and the prognosis is worse for patients who do not see their cancer eradicated with standard treatments (refractory) or who see their cancer return after an initial response (relapse) . ).
About 40% of people diagnosed with multiple myeloma do not survive five years
So far, two CAR-T therapies have been approved for use in these patients, in which the patient’s own immune cells are removed, genetically modified and then reinfused into the body to attack and kill tumor cells.
Cilta-cel was approved for use in 2022 in patients whose multiple myeloma had not been eradicated or had relapsed after four or more prior lines of therapy.
Previous therapy
For the new study, researchers retrospectively analyzed outcomes among 255 patients who began the cilta-cel administration trial between March and December 2022. Study participants had undergone an average of six prior lines of therapy (and up to to 18 lines of therapy) without observing a lasting response.
As a real-world retrospective study, it did not include a control group, and there may have been discrepancies in the assessment and reporting of results among the 16 centers that provided the data, the researchers acknowledge.
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