Axicabtagene ciloleucel 作为不适合自体干细胞移植的大 B 细胞淋巴瘤患者的二线治疗：一项 2 期试验

Axicabtagene ciloleucel (axi-cel) demonstrated superior efficacy compared to standard of care as second-line therapy in patients with high-risk relapsed/refractory (R/R) large B cell lymphoma (LBCL) considered eligible for autologous stem cell transplantation (ASCT); however, in clinical practice, roughly half of patients with R/R LBCL are deemed unsuitable candidates for ASCT. The efficacy of axi-cel remains to be ascertained in transplant-ineligible patients. ALYCANTE, an open-label, phase 2 study, evaluated axi-cel as a second-line therapy in 62 patients with R/R LBCL who were considered ineligible for ASCT. The primary end point was investigator-assessed complete metabolic response at 3 months from the axi-cel infusion.

Key secondary end points included progression-free survival, overall survival and safety. The study met its primary end point with a complete metabolic response of 71. 0% (95% confidence interval, 58. 1-81. 8%) at 3 months. With a median follow-up of 12. 0 months (range, 2. 1-17. 9), median progression-free survival was 11. 8 months (95% confidence interval, 8.

4-not reached) and overall survival was not reached. There was no unexpected toxicity. Grade 3-4 cytokine release syndrome and neurologic events occurred in 8. 1% and 14. 5% of patients, respectively. These results support axi-cel as second-line therapy in patients with R/R LBCL ineligible for ASCT. ClinicalTrials. gov Identifier: NCT04531046 .