Kite, a Gilead Company, announced new findings at the 67th American Society of Hematology (ASH) Annual Meeting confirming that second-line Yescarta® (axicabtagene ciloleucel) provides sustained efficacy, safety, and quality-of-life benefits for patients with relapsed or refractory large B-cell lymphoma (R/R LBCL), including those ineligible for high-dose chemotherapy and autologous stem cell transplant (ASCT).

The analysis integrated four-year outcomes from the pivotal Phase 3 ZUMA-7 trial with two-year results from the Phase 2 ALYCANTE study, conducted in ASCT-ineligible patients. According to investigators, Yescarta’s performance supports its positioning as a second-line standard of care.

Key efficacy outcomes after two years included:
• Overall survival (OS): 64.9% (pooled), compared with historical rates near 20%.
• Event-free survival (EFS): 45.2% (pooled).
• Progression-free survival (PFS): 47.4% (pooled).

Patients also demonstrated strong early responses, with a complete metabolic response (CMR) of 55.6% at three months and durable benefit reflected in a 12-month duration of response (DOR) of 61%.

Safety results from 232 treated patients showed comparable tolerability between studies. Rates of Grade ≥3 treatment-emergent adverse events were similar (pooled 90.5%), with manageable profiles across neurologic and hematologic events.

Quality-of-life metrics demonstrated short-term declines followed by marked improvement beginning around Day 100–150 and sustained through two years.

Kite leaders emphasized that the combined data reinforce Yescarta’s potential as a treatment with curative intent and highlight the company’s commitment to transforming outcomes for patients with aggressive lymphomas.