BREYANZI (lisocabtagene maraleucel) 1.1-70x10^6 cells/mL/1.1-70x10^6 cells/mL dispersion for infusion

Considering all these elements, the Committee deems that the clinical benefit of BREYANZI (lisocabtagene maraleucel) 1.1-70x10^6 cells/mL/1.1-70x10^6 cells/mL dispersion for infusion is substantial in the MA indication.

Considering:

• demonstration of the superiority of BREYANZI (lisocabtagene maraleucel) compared to a treatment sequence composed of salvage immunochemotherapy, potentially followed, in the event of a response, by high-dose chemotherapy (intensification) and autologous HSCT in a randomised phase 3 study (TRANSFORM study) in 184 adult patients with aggressive B-cell NHL, refractory or in relapse within 12 months following completion of first-line therapy and eligible for autologous HSCT, in terms of event-free survival (superiority of liso-cel in terms of EFS compared to the standard of care (HR=0.36; CI95% [0.24; 0.52]; p<0.0001)), complete response rate (higher in the liso-cel group than in the control group, 73.9% vs 43.5%; p<0.0001) and progression-free survival rate (HR=0.40; CI95% [0.26; 0.62]; p<0.0001);
• data from two non-comparative studies, having demonstrated overall response rates of 80.3% (CI95%: 68.2-89.4) and 63% (CI95%: 42.4; 80.6) in patients not eligible for a strategy including autologous HSCT;
• a safety profile marked primarily by haematological (neutropenia, thrombopenia, anaemia) and neurological toxicity (15 to 64% of patients depending on the studies), as well as a cytokine release syndrome (38 to 49% of patients depending on the studies);

and despite:

• the absence of a demonstrated benefit in terms of overall survival in the comparative phase 3 TRANSFORM study, but considering the non-negligible percentage of patients in the standard of care arm having received a CAR-T as third-line therapy following progression or an inadequate response;
• the non-comparative and purely descriptive nature of the studies conducted in patients not eligible for a strategy including autologous HSCT (TRANSCEND PILOT and TRANSCEND-WORLD) leading to uncertainties with respect to the efficacy results observed, but considering the lack of consensus concerning assessment of eligibility or otherwise for autologous HSCT, left to the decision of the physician;
• the small number of patients with the FL3B subtype (one patient in each of the three studies) given the fact that this rare form is treated in the same way as other large B-cell lymphomas;
• the absence of any formal conclusion that can be drawn based on the quality-of-life results;

the Committee deems that BREYANZI (lisocabtagene maraleucel) 1.1-70x10^6 cells/mL/1.1-70x10^6 cells/mL dispersion for infusion provides a moderate clinical added value (CAV III) in the current care pathway, which includes the relevant comparators cited in paragraph 5.2.