Kite's Yescarta Shows Durable Benefits In R/R Large B-Cell Lymphoma Across Phase 3 & Phase 2 Studies

Gilead Sciences

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(RTTNews) - Kite, a Gilead Company (GILD), presented a new analysis demonstrating that second-line therapy with Yescarta (axicabtagene ciloleucel) delivers consistent benefits for patients with relapsed/refractory large B-cell lymphoma (R/R LBCL). Importantly, these benefits extend even to patients who are ineligible for the previous standard of care, which involved high-dose chemotherapy followed by autologous stem cell transplant (ASCT).

The findings were based on a combined analysis of four-year data from the landmark Phase 3 ZUMA-7 pivotal study of Yescarta in R/R LBCL, alongside two-year data from the Phase 2 ALYCANTE study. ALYCANTE was designed by the French collaborative group LYSA and sponsored by LYSARC to specifically evaluate transplant-ineligible patients.

After two years of follow-up, overall survival (OS) rates were encouraging: 64.9% in the pooled analysis, 62.8% in ZUMA-7, and 70.8% in ALYCANTE. Historically, outcomes for R/R LBCL patients were poor, with two-year survival rates of only about 20% prior to the advent of CAR T-cell therapies. Event-free survival (EFS) rates were 45.2% in the pooled analysis, 45.4% in ZUMA-7, and 44.7% in ALYCANTE. Progression-free survival (PFS) rates were similarly strong at 47.4%, 47.6%, and 46.8%, respectively.

Additional measures reinforced the therapy's impact. After three months, 55.6% of patients in the pooled analysis achieved a complete metabolic response (CMR), with 51.2% in ZUMA-7 and 67.7% in ALYCANTE. At one year post-treatment, the overall response rate (ORR) was 46.6% in the pooled analysis, 46.5% in ZUMA-7, and 46.8% in ALYCANTE. Among patients who responded, 61% maintained their response at 12 months, with duration of response (DOR) rates of 61.0% pooled, 60.6% in ZUMA-7, and 62.1% in ALYCANTE.

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