Figure 5.
Tisagenlecleucel dose-exposure, dose-response, and dose-safety analyses. Dose-exposure analysis: (A) Scatter plot of Cmax vs CAR+ viable T-cell dose. Dose-response analysis: (B) Logistic regression of 3-month response vs CAR+ viable T-cell dose, overlaid with individual data. (C) Kaplan-Meier plot of DOR, based on response at any time, by median CAR+ viable T-cell dose. Dose-safety analysis: (D) Logistic regression of grade 3/4 CRS vs CAR+ viable T-cell dose, overlaid with individual data. The estimated OR for having grade 3/4 CRS with a twofold increase in dose was 2.82 (95% CI, 1.116-7.150). After adjusting for baseline tumor burden, the estimated OR for having grade 3/4 CRS with a twofold increase in dose was 2.246 (95% CI, 0.684-7.375). (E) Logistic regression of grade 3/4 neurologic events vs CAR+ viable T-cell dose, overlaid with individual data. The estimated OR for having grade 3/4 neurologic events with a twofold increase in dose was 0.89 (95% CI, 0.445-1.801).

Tisagenlecleucel dose-exposure, dose-response, and dose-safety analyses. Dose-exposure analysis: (A) Scatter plot of Cmax vs CAR+ viable T-cell dose. Dose-response analysis: (B) Logistic regression of 3-month response vs CAR+ viable T-cell dose, overlaid with individual data. (C) Kaplan-Meier plot of DOR, based on response at any time, by median CAR+ viable T-cell dose. Dose-safety analysis: (D) Logistic regression of grade 3/4 CRS vs CAR+ viable T-cell dose, overlaid with individual data. The estimated OR for having grade 3/4 CRS with a twofold increase in dose was 2.82 (95% CI, 1.116-7.150). After adjusting for baseline tumor burden, the estimated OR for having grade 3/4 CRS with a twofold increase in dose was 2.246 (95% CI, 0.684-7.375). (E) Logistic regression of grade 3/4 neurologic events vs CAR+ viable T-cell dose, overlaid with individual data. The estimated OR for having grade 3/4 neurologic events with a twofold increase in dose was 0.89 (95% CI, 0.445-1.801).

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