使用真实世界合成对照臂直接比较 lisocabtagene maraleucel 与常规治疗用于复发/难治性大 B 细胞淋巴瘤

This study used a real-world population as a synthetic comparator for the single-arm TRANSCEND NHL 001 study (TRANSCEND; NCT02631044) to evaluate the efficacy of lisocabtagene maraleucel (liso-cel) compared with conventional (noncellular) therapies in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL). Inclusion and exclusion criteria for the real-world study closely matched the enrollment criteria in TRANSCEND. The analytic comparator cohort was created by matching and balancing observed baseline characteristics of real-world patients with those in TRANSCEND using propensity score methodology.

Efficacy outcomes comparing liso-cel- ( n = 257) and conventional therapy-treated ( n = 257) patients, respectively, significantly favored liso-cel: overall response rate (74% vs 39%; p < 0. 0001), complete response rate (50% vs 24%; p < 0. 0001), median overall survival (23. 5 vs 6. 8 months; p < 0.

0001), and median progression-free survival (3. 5 vs 2. 2 months; p < 0. 0001). These results demonstrated a statistically significant and clinically meaningful benefit of liso-cel in patients with third- or later-line R/R LBCL relative to conventional therapies. Clinical trial registration: ClinicalTrials. gov identifier: NCT02631044.