Lisocabtagene maraleucel receives accelerated U.S. FDA approval for adult patients with R/R FL

On May 15, 2024, it was announced that the U.S. Food and Drug Administration (FDA) had granted accelerated approval to lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor T-cell therapy, for the treatment of adult patients with relapsed/refractory follicular lymphoma after ≥2 prior lines of systemic therapy.¹ This approval was based on positive response data from the phase Il TRANSCEND FL trial (NCT04245839).¹

The TRANSCEND FL trial

TRANSCEND FL is a global, open-label, single-arm phase II study investigating the safety and efficacy  of liso-cel in patients with relapsed/refractory indolent B-cell non-Hodgkin lymphoma, including follicular lymphoma.¹ Among the evaluable patients (n = 94)^1,2:

• The overall response rate was 95.7% (95% CI, 89.5−98.8).
• The complete response rate was 73.4% (95% CI, 63.3-82.0).
• Durable and rapid responses were observed:

• • median time to response was 1 month (range, 0.6-3.3 months);
  • at a median follow-up of 16.8 months, the duration of response was not reached (95% CI, 18.04−NR);
    
  • at 12 months, 80.9% of responders remained in ongoing response; and
  • at 18 months, 77.1% of responders remained in ongoing response.

• The most commonly reported adverse reactions in ≥20% of patients were:
  • cytokine release syndrome;
  • headache;
  • musculoskeletal pain;
  • fatigue;
  • constipation; and
  • fever.

Liso-cel comes with a boxed warning for cytokine release syndrome, neurologic toxicities, and secondary hematologic malignancies.^1,2

The U.S. FDA has recommended a liso-cel dose of 90−110 × 10⁶ viable chimeric antigen receptor T-cells with a 1:1 ratio of CD4 and CD8 components.² Liso-cel is also included in the National Comprehensive Cancer Network clinical practice guidelines as a recommendation for third line and subsequent therapy for relapsed or refractory follicular lymphoma.¹