Abstract Introduction: Liso-cel, an autologous, CD19-directed CAR T cell product, has demonstrated consistent efficacy in a broad population of pts with B-cell malignancies, including R/R LBCL. Its well-established safety profile has made OP delivery commonplace. This, combined with recent changes to postinfusion monitoring requirements, offers pts the potential for greater access to care. Here, we describe real-world safety and effectiveness outcomes for pts with R/R LBCL who received liso-cel as standard of care (SOC) therapy in the inpatient (IP) or OP setting. Methods: This was an observational study of pts in the US with R/R LBCL who received commercial liso-cel as second-line (2L) or later treatment (tx) in the IP or OP setting between 02/2021 and 02/2025 and had ≥1 postinfusion assessment reported in the Center for International Blood pulmonary, 30% and 26%; active infections requiring ongoing tx, 6% and 3%) of pts in the IP and OP groups, respectively. Median (range) number of prior lines of therapy was 3 (1–13) in the IP group and 3 (1–16) in the OP group. Use of bridging therapy was reported in 65% of the IP group and 62% of the OP group. Median (95% CI) follow-up for this study was 12.7 mo (12.5–13) in the IP group and 12.6 mo (12.4–12.8) in the OP group. Safety was similar in both settings; any-grade CRS was reported in 52% of IP vs 49% of OP setting pts, with low rates of grade 2 CRS (15% vs 11%) and grade ≥3 CRS (3% vs 2%) in both groups. Any-grade immune effector cell–associated neurotoxicity syndrome (ICANS) rates were also similar in pts in the IP vs OP setting (28% vs 23%), with low rates of grade 2 ICANS (5% vs 4%) and grade ≥3 ICANS (10% vs 8%). Prolonged cytopenia (grade 4 thrombocytopenia and/or neutropenia at 30 d after infusion) was reported in 12% and 14% in the IP and OP groups; clinically significant infections at any time after infusion occurred in 48% of IP and 42% of OP setting pts. In the IP and OP groups, 37% and 30% of pts died, most commonly due to PD (25% and 21%) and the NRM rates at 12 mo were 7.1 (95% CI, 5.2–9.4) and 4.1 (95% CI, 2.2–6.8). Among OP setting pts, 46% were not hospitalized after infusion; of those hospitalized after OP infusion, median (IQR) time to hospitalization was 5 d (3-8) and duration of stay was 5 d (3-9). Response rates were high in both the IP (ORR, 80% 95% CI, 77–83; CR rate, 70% 95% CI, 66–73) and OP setting (ORR, 83% 95% CI, 79–87; CR rate, 74% 95% CI, 69–79). At ~12 mo follow-up, median (95% CI) DOR was not reached (NR; NR–NR) in either group with 12-mo DOR rates of 59% (95% CI, 54–63) and 63% (95% CI, 56–69), respectively. Median (95% CI) PFS was 11.8 mo (8.8–NR) in the IP group vs NR (NR–NR) in the OP group, with 12-mo PFS rates of 49% (95% CI, 45–53) and 56% (95% CI, 50–61), respectively. Median (95% CI) OS was NR (NR–NR) in both groups with 12-mo OS rates of 65% (95% CI, 61–68) in the IP group and 74% (95% CI, 68–78) in the OP group. Conclusions: These results continue to demonstrate that one-time tx with liso-cel results in deep, clinically meaningful efficacy in the SOC setting across a broad population of pts with R/R LBCL. Despite the few differences reported in baseline characteristics, outcomes were consistent among pts treated in the IP and OP care settings. The well-established safety profile of liso-cel is conducive to OP tx, allowing ~50% of pts to remain out of the hospital postinfusion.
Sdrimas et al. (Mon,) studied this question.