Phase II ALYCANTE trial: Second-line axicabtagene ciloleucel in LBCL

Results from the final analysis of the phase II ALYCANTE trial (NCT04531046) evaluating axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, as a second-line treatment in 62 transplant-ineligible patients with high-risk relapsed/refractory (R/R) large B-cell lymphoma (LBCL) were published in HemaSphere by Houot et al. The primary endpoint was the complete metabolic response (CMR) rate at 3 months.

Key data: At a median follow-up of 37.4 months, the 3-month CMR rate was 71.0% (95% confidence interval [CI], 58.1–81.8), with a best overall response rate (ORR) of 90.3% (95% CI, 81.8–95.7). The best CMR was 79.0% (95% CI, 68.7–87.1). The 36-month progression-free survival (PFS) and overall survival (OS) rates were 37.3% (95% CI, 25.0–49.5) and 55.9% (95% CI, 42.6–67.3), respectively. Median PFS was 18.0 months, with a median duration of response (DoR) of 26.0 months. Median OS was not reached (NR). Survival and DoR outcomes were consistent across age (<70 vs ≥70 years) and hematopoietic cell transplantation–comorbidity index (HCT-CI) subgroups (score, <3 vs ≥3). Overall, 96.8% of patients had Grade ≥3 adverse events (AEs); the most frequently reported AEs were neutropenia (67.7%), anemia (40.3%), and thrombocytopenia (38.7%). A total of 27 patients died during the study.

Key learning: In the final analysis of the ALYCANTE trial, axi-cel demonstrated durable responses and long-term survival with no new safety signals, supporting its use as a second-line therapy in transplant-ineligible patients with high-risk R/R LBCL.