Table 5.
PFS and OS MAIC results for the comparison of liso-cel to tisagenlecleucel, infused patients
JULIET (tisagenlecleucel) efficacy analysis set [8] | TRANSCEND (liso-cel) DLBCL efficacy set [6] | Liso-cel vs tisagenlecleucel | ||||
---|---|---|---|---|---|---|
N | Median, months (95% CI) | n or ESS | Median, months (95% CI)a | HR (95% CI) | P-value | |
PFS analyses | ||||||
Naive | 111 | 2.8 (2.3‒4.2)b | 256 | 6.8 (3.5‒17.7) | 0.67 (0.49‒0.91) | 0.009 |
Primary | 149.3 | 6.7 (3.5‒NR) | 0.65 (0.47‒0.91) | 0.012 | ||
Sensitivity | 24.8 | 5.9 (3.1‒NR) | 0.55 (0.32‒0.96) | 0.035 | ||
OS analyses | ||||||
Naive | 111 | 11.7 (7.2‒NR)b | 256 | 21.1 (3.3‒NR) | 0.73 (0.52‒1.02) | 0.062 |
Primary | 180 | 22.0 (16.8‒NR) | 0.67 (0.47‒0.95) | 0.026 | ||
Sensitivity | 24.8 | 19.9 (9.2‒NR) | 0.68 (0.42‒1.10) | 0.115 |
CI confidence interval, DLBCL diffuse large B-cell lymphoma, ESS effective sample size, HR hazard ratio, IPD individual patient data, liso-cel lisocabtagene maraleucel, MAIC matching-adjusted indirect comparison, NR not reached, OS overall survival, PFS progression-free survival
aCIs for the medians were estimated using cumulative hazard function
bThe median was obtained from pseudo-IPD based on a digitized Kaplan–Meier curve