YESCARTA® is indicated for the treatment of adult patients with r/r follicular lymphoma (FL) after three or more lines of systemic therapy.¹
The efficacy and safety of Yescarta® in r/r FL
The efficacy and safety of Yescarta in adult patients with FL, were evaluated in a phase 2 single-arm, open-label, multicentre study in patients with r/r FL based on 2016 WHO-classification. At the time of the primary analysis, a total of 122 FL patients were enrolled (i.e. leukapheresed), including 75 patients who had received 3 or more lines of previous therapy. The primary endpoint was ORR. Secondary endpoints included CR rate, ORR and CR in patients who received 3 or more lines of prior therapy, DOR, OS and PFS and incidence of adverse events.¹
Key efficacy results for FL patients with 3 or more prior lines of therapy are presented below.¹
24 months follow-up
The 24-month follow-up analysis demonstrated that single Yescarta-infusion resulted in an ORR of 91% [95% CI (82, 96)] and CR rate of 77%.¹
ORR, CR, PR and mDOR for FL patients with 3 or more prior lines of therapy. Picture adapted from SmPC.¹
Durable responses
The median time to response was 1 month (range: 0.8 to 3.1 months), the median DOR was 38.6 months [95% CI] (24.7, NE) and the proportion of responders who remained in response was 62% at Month 24.¹
Safety profile of YESCARTA® in FL
Safety data from ZUMA-5 reflects exposure to Yescarta in a Phase 2 study for 119 patients with relapsed/refractory FL.¹
The most significant and frequently occurring adverse reactions were CRS (77%), infections (59%), and encephalopathy (47%).¹
Serious adverse reactions occurred in 45% of patients. The most common (≥ 5%) serious adverse reactions included encephalopathy (16%), unspecified pathogen infections (12%), CRS (12%), and bacterial infection (5%).¹
Please see the summary of product characteristics for full information on the safety profile of YESCARTA®.
References
- Yescarta Summary of Product Characteristics
SE-TEC-0033 | 09/2024
Related information
Latest EMA approval: Yescarta in 2L DLBCL
In October 2022, Yescarta was approved in the EU 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.
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