Lisocabtagene maraleucel receives EC approval for the treatment of adult patients with R/R LBCL after one prior therapy

On May 3, 2023, it was announced that lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, received approval from the European Commission (EC) for the treatment of adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma Grade 3B (FL3B) after one prior therapy.¹

This approval is based on results from the phase III TRANSFORM trial (NCT03575351),¹ in which liso-cel was compared with standard therapy. Below, we report the key data:

• In an interim analysis with median follow up of 6.2 months, event-free survival (EFS) for liso-cel compared with standard therapy was 10.1 months vs 2.3 months, respectively (HR, 0.349; 95% confidence interval [CI], 0.229–0.530; p < 0.0001).¹
• In the primary analysis at a median follow-up of 17.5 months, EFS was not reached for liso-cel vs 2.4 months for standard therapy (95% CI, 9.5–NR vs 2.2–4.9).¹
• Liso-cel achieved a complete response rate of 73.9% compared with 43.5% for standard therapy.¹
• Median progression-free survival was not met (95% CI, 12.6–NR) for liso-cel vs 6.2 months (95% CI, 4.3–8.6) for standard therapy (HR, 0.400; 95% CI, 0.261–0.615).¹

Liso-cel showed improved EFS compared to standard of care with a manageable safety profile.¹ These data support the use of liso-cel as a second-line treatment for patients with primary refractory or early relapsed LBCL.²