The quality-of-life improvement with Abecma in patients with relapsed/refractory multiple myeloma was greater when compared with standard regimens.
Abecma (idecabtagene vicleucel) significantly improved symptoms, functioning and health-related quality of life in patients with relapsed/refractory multiple myeloma who received two to four prior regimens, recent study findings demonstrated.
Results from the phase 3 KarMMa-3 trial were presented at the 2023 ASH Meeting.
“These (patient-reported outcome) data highlight the extended (quality-of-life) benefits of a single infusion with (Abecma) compared with the continuous treatment in patients with relapsed/refractory multiple myeloma,” Dr. Michel Delforge, chairman of Leuven Cancer Institute at Leuven University College in Belgium, said during the presentation of the data.
Compared with standard regimens, Abecma demonstrated significant and meaningful improvements in global health status, quality of life and visual analog scale, observations Delforge noted as “most important” during his presentation. In the global health status and quality of life metric, there was an initial steep decline in global health status for patients assigned Abecma.
“Most likely it was explained by the fact that those patients were not allowed to receive any new type of bridging therapy,” Delforge said.
Shortly after this decline in global health status (an assessment of a patient’s overall wellbeing) and quality of life scores, there was a rapid increase, which was statistically significant with Abecma when compared with standard regimens.
Similar observations were made regarding fatigue and pain, where Abecma also showed a clinically meaningful improvement compared with standard regimens.
Improvements were also observed when assessing physical and cognitive functioning.
“One of the reasons to look at cognitive function in this setting was that there was a potential risk that with (Abecma), shortly after infusion, there could be a decline in cognitive functioning because of neurotoxicity like ICANS (immune effector cell-associated neurotoxicity syndrome),” Delforge explained.
ICANS refers to neurological side effects that may occur as a result of immunotherapy including CAR T-cell therapy. Symptoms of this syndrome may include delirium confusion, seizures and other neurological issues.
Patients assigned Abecma also had improvements in disease symptoms and side effects from treatment compared with those assigned standard regimens.
Researchers also analyzed between-group differences in all patient-reported outcome domains from baseline to month 25. Of note, the changes during this time demonstrated significant differences favoring patients assigned Abecma in most domains assessed in the scores. Also, the difference in changes favored Abecma in 13 domains.
The time to confirmed improvement was also statistically faster in patients assigned Abecma compared with standard regimens in 19 out of 21 domains – except for financial difficulty and diarrhea domains.
The time to confirmed deterioration was significantly longer in the Abecma group compared with the standard regimen group for cognitive, emotional and social functioning, constipation, shortness of breath and treatment-related side effects. Delforge noted more significant differences across domains towards patients assigned Abecma for time to improvement versus time to deterioration.
In the phase 3 KarMMa-3 trial, researchers assessed health-related quality of life in 386 patients who had received two to four prior regimens and were randomly assigned to receive Abecma (254 patients) or standard regimens (132 patients).
Several metrics were used to assess health-related quality of life throughout the study, some of which were focused particularly on patients with multiple myeloma. These assessments were completed during screening at the start of the study, the day of Abecma infusion or the first dose of standard treatment, each month starting at month 2 up until 28 months, and every 3 months afterwards.
Patients with relapsed/refractory multiple myeloma often have limited treatment options and poor prognosis, in addition to substantial pain, fatigue, and quality of life. Abecma is a first-in-class CAR T-cell therapy for those with this specific disease. In the phase 2 KarMMa trial, Abecma showed deep and durable responses, as well as improved health-related quality of life in patients with relapsed/refractory multiple myeloma.
In a preliminary analysis of the phase 3 KarMMA-3 trial performed in 2022, results demonstrated a longer progression-free survival (the time during and after treatment when a patient with cancer lives without disease worsening) when Abecma was compared with standard regimens (13.3 months vs 4.4 months, respectively).
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