TRANSCEND FL phase II: Lisocabtagene maraleucel in R/R MZL

Results from the marginal zone lymphoma (MZL) cohort of the global, single-arm, phase II TRANSCEND FL study (NCT04245839), evaluating lisocabtagene maraleucel in patients with relapsed/refractory (R/R) MZL after ≥2 lines of systemic therapy, were published in The Lancet by Palomba et al. The primary endpoint was overall response rate (ORR) per independent review committee (IRC). Secondary endpoints included complete response (CR) rate, duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety.

Key data: In 66 efficacy-evaluable patients with R/R MZL, the ORR was 95% (95% confidence interval [CI], 87.3–99.1; p < 0.0001), with a CR rate of 62% (95% CI, 49.3–73.8; p < 0.0001). The median DoR was not reached (NR), while the 24‑month DoR rate was 89%. The median PFS and OS were NR, with 24‑month PFS and OS rates of 86% and 90%, respectively. The most common any grade treatment-emergent adverse events (TEAEs) were cytokine release syndrome (CRS; 76%), neutropenia (75%), and thrombocytopenia (39%). Grade ≥3 TEAEs occurred in 88% of patients.

Key learning: Lisocabtagene maraleucel demonstrated high, durable responses with a manageable safety profile in the MZL cohort of this study, supporting its potential as a treatment option for patients with R/R MZL after ≥2 prior lines of therapy.