Yescarta in 2L DLBCL

YESCARTA^® is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.¹ 

YESCARTA^® for the treatment of 2L DLBCL

Yescarta was approved by the European Medicines Agency (EMA) for the treatment of 2L R/R DLBCL in November 2022.

Yescarta is, as of January 2024, recommended by the NT-rådet for use in 2L R/R Diffuse Large B-Cell Lymphoma (DLBCL) as per the label.² The recommendation from NT-rådet reads:

“NT-rådet rekommenderar Yescarta^® för behandling av vuxna patienter med DLBCL och höggradigt B-cellslymfom (HGBL) som återfaller inom 12 månader efter avslutad, eller är refraktära mot, behandling med kemoimmunoterapi i första linjen.”²

The efficacy and safety of Yescarta^® in 2L DLBCL

The efficacy and safety of Yescarta in adult patients with r/r DLBCL was demonstrated in a Phase 3 randomised, open-label, multicenter study (ZUMA-7). ZUMA-7 is the largest Phase 3 CAR T trial for 2L DLBCL (N=359) with the longest follow-up period to date (24.9-month median follow-up). A total of 180 patients were randomly assigned to receive Yescarta and 179 to receive Standard of Care (SOCT defined as investigator-selected chemoimmunotherapy, with the intention to proceed to high-dose chemotherapy with autologous stem-cell transplantation). The primary endpoint was event-free survival (EFS) as determined by blinded central review.^1,3

Primary efficacy endpoint: YESCARTA demonstrated significant improvement in EFS vs SOCT

More than double the number of patients treated with YESCARTA remain event free at 2 years compared with SOCT.^1,2

Significantly improved Overall Survival (OS)

Yescarta^® is the only CAR T to demonstrate superior OS in 2L DLBCL R/R ≤12 months vs Standard of Care therapy (SOCT, defined as salvage chemotherapy +/-  high dose chemotherapy and Autologous Stem Cell Transplant, ASCT) in the curative setting³ 

• 55% of patients were alive at 4 years with Yescarta^® vs 46% with SOCT, despite that 57% of control patients received rescue therapy with 3L cellular immunotherapy^1,3 
• Risk of death was reduced by 27% at 4 years vs SOCT^3,a 
• Overall survival benefit was similar across key patient subgroups³ 
• The safety profile of Yescarta^® remained consistent with prior studies^1,3 

Safety profile of YESCARTA^® in 2L DLBCL

Safety data for Yescarta in 2L DLBCL is consistent with previous 3L DLBCL trial results (ZUMA-1).^1,3
Safety data from ZUMA-7 reflects exposure to Yescarta in a Phase 3 study for 170 patients.

The most significant and frequently occurring adverse reactions were CRS (92%), encephalopathy (49%), and infections (45%).
Serious adverse reactions occurred in 54% of patients. The most common (≥5%) serious adverse reactions included CRS (17%), encephalopathy (16%), unspecified pathogen infections (8%), fever (6%) and viral infection (5%).^1,3

Please see the summary of product characteristics for full information on the safety profile of YESCARTA^®.¹

Footnote

^a Hazard ratio [HR] 0.73; 95 % CI: 0.54–0.98, stratified two-sided log-rank, P-value = 0.03.3 

References

1. Yescarta® SmPC, 01/2024.
2. NT-rådet. Yescarta (axicabtagen ciloleucel) vid diffust storcelligt B-cellslymfom (DLBCL), 2:a linjens behandling. NT-rådets yttrande till regionerna 2024-01-12. janusinfo.se/download/18.6dc8258018ce570cce88e318/1705051242144/Yescarta%202L%20DLBCL%202024-01-12.pdf.
3. Westin JR, Oluwole OO, Kersten DB, et al. Survival with Axicabtagene Ciloceucel in Large B-Cell Lymphoma.
   NEJM. June 5, 2023. DOI: 10.1056/NEJMoa2301665.

SE-TEC-0031v2.0 | 06/24