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Ciltacabtagene autoleucel was found to elicit clinically meaningful improvements in health-related quality of life in patients with relapsed/refractory multiple myeloma, and this benefit may become even more pronounced as responses to treatment deepen over time, according to data from the CARTITUDE-1 study presented during the 2020 ASH Annual Meeting & Exposition.
Ciltacabtagene autoleucel (JNJ-68284528; cilta-cel) was found to elicit clinically meaningful improvements in health-related quality of life (HRQoL) in patients with relapsed/refractory multiple myeloma, and this benefit may become even more pronounced as responses to treatment* deepen over time, according to data from the CARTITUDE-1 study (NCT03548207) presented during the 2020 ASH Annual Meeting & Exposition.1
For 68 patients in the phase 2 portion of the trial, HRQoL was analyzed using 3 patient-reported instruments: the European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-30), EORTC QLQ-MY20, and EQ-5D-5L visual analogue scale (VAS). These instruments assessed for global health status (GHS), functional scales, and symptom scales; emotional health status; and current health status, respectively.
There were clinically meaningful improvements observed for patients 100 days after their single infusion of cilta-cel. These improvements were seen with pain in 72% of 54 patients, fatigue in 54% of 52, physical functioning in 58% of 52, and GHS in 54% of 54 for the EORTC QLQ-C30. Out of 53 patients who completed the EORTC QLQ-MY20 assessment, 81% reported a meaningful improvement in being restless or agitated, 51% thought less about their illness, about dying (42%), and about their future health (32%).
“Multiple myeloma negatively affects health-related quality of life and further declines happen with each relapse,” Thomas Martin III, MD, from the University of California San Francisco, said in his presentation. “Because of this, quality of life is an important consideration in managing and evaluating new therapies.”
At 100 days post infusion, patients with a deeper treatment response showed a trend toward greater improvement in GHS, physical function, pain, and fatigue. For non-responders, scores were difficult to interpret since there were only 2 patients who did not respond to therapy. There was also 1 non-responder patient with progressive disease who was excluded due to lack of interviews, according to Martin. There was a similar trend toward improved patient-reported outcomes with deeper treatment response observed with the EQ-5D-5L VAS scores.
At day 7 post infusion, there was a worse score for improvement in physical function and GHS, then a gradual improvement over time, seen 1 to 2 months after infusion and continuing to day 212, which was the latest time point.
“Conversely, mean changes in pain and fatigue showed reduction over time, following initial worsening of fatigue at day 7. These reductions were observed through day 212, where patients reported levels of fatigue and pain that were below baseline values,” Martin explained.
Change in HRQoL was looked at from baseline and investigators assessed the percentage of those with clinically meaningful improvement. Completion rate of the questionnaires were high at baseline, at 92.6% (63/68). By day 212, completion rates were still relatively high with 67.9% (36/68) completing each questionnaire.
Limitations to this analysis of HRQoL included that the patient-reported outcomes were based on a relatively small sample size and the results were an exploratory and descriptive summary of these patients’ self-reported outcomes.
In the initial results of this phase 1b/2 trial, patients receiving the single infusion of cilta-cel following lymphodepletion chemotherapy demonstrated deep, durable responses, with an overall response rate of 96.9% (95% CI, 91.2%-99.4%), and 67% of patients experienced a stringent complete response.2
Those who were penta-drug exposed made up 86.8% (59/68), meaning they received treatment with at least 2 proteasome inhibitors, 2 immunomodulatory drugs, and 1 anti-CD38 antibody; 88.2% (60/68) were triple-class refractory, and were refractory to at least 1 proteasome inhibitors, 1 immunomodulatory drug, and 1 anti-CD38 antibody; and patients who were penta-drug refractory to all 5 previous therapies made up 47.1% (32/68).
Eligibility for this trial included at least 3 prior lines of treatment or double-class refractory to a proteasome inhibitor, immunomodulatory drug, and/or an anti-CD38 antibody. They also had to have an ECOG performance status of 1 or more, measurable disease, and progressive multiple myeloma per International Myeloma Working Group criteria. There was a median of 6 prior therapies in this group of patients, a median age of 62 years, and 63.2% of patients were male.
“In summary, patients with heavily pretreated multiple myeloma reported rapid, clinically meaningful improvements in health-related quality of life after a single cilta-cel infusion. The improvement in physical function, general health status, pain, fatigue, and emotional status were consistent with clinical outcomes. We observed a trend toward greater improvements in patients with deeper clinical responses, which suggests patients may experience further quality-of-life improvements as their treatment response deepens over time,” Martin concluded.