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Axicabtagene Ciloleucel (Yescarta): CADTH Reimbursement Review: Therapeutic area: Large B-cell lymphoma [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2023 Jun.

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Axicabtagene Ciloleucel (Yescarta): CADTH Reimbursement Review: Therapeutic area: Large B-cell lymphoma [Internet].

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The y-axis is the estimate (95%) ranging from –40 to 40; the x-axis is the study visit ranging from screening to study month 15. Points with bars depicting the 95% CI are shown at each study visit with lines connecting them. The estimates for both groups are 0 at the screening visit. At study day 50, the estimate is –10 in the SOC arm and approximately –14 in the axi-cel arm. The estimate then increases in the axi-cel arm, crossing 0 by study day 150. The estimate decreases in the SOC arm at study day 100 then increases and crosses the axi-cel arm’s line by study month 12.

Figure 8EORTC QLQ-C30 Physical Functioning Mixed Model With Repeated Measures for Change From Screening (QoL Analysis Set)

Source: Clinical Study Report for Yescarta.15

CI = confidence interval; EORTC QLC-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; MMRM = mixed model with repeated measures; QoL = quality of life.

Notes: Study day denotes number of days since the day of randomization. Results populated only through month 15 due to lack of model convergence when using time points. Horizontal lines represent the minimal important difference thresholds for meaningful change and are provided for clarity of interpretation. This model included variables for treatment, time, and treatment by time interaction (primary analysis) and controlled for response to first-line therapy (primary refractory, relapse ≤ 6 months of first-line therapy vs. relapse > 6 and ≤ 12 months of first-line therapy) and age-adjusted International Prognostic Index (0 to 1 vs. 2 to 3) at time of screening.

Data cut-off date: March 18, 2021.

From: Clinical Review

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Copyright © 2023 - Canadian Agency for Drugs and Technologies in Health. Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial- NoDerivatives 4.0 International licence (CC BY-NC-ND).

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