YESCARTA® is indicated for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) and primary mediastinal large B cell lymphoma (PMBCL), after two or more lines of systemic therapy.¹
The efficacy and safety of Yescarta® in 3L DLBCL/PMBCL
The efficacy of YESCARTA® is based on data from the Phase 2, open-label, single-arm ZUMA-1 trial. In the trial, 101 adults with DLBCL, PMBCL or transformed follicular lymphoma (TFL) received YESCARTA®.² The primary endpoint was objective response rate (ORR). Secondary endpoints included duration of response (DOR), overall survival (OS), and severity of adverse events.¹
5 and alive with Yescarta: 5-year OS data
In the 5-year follow up analysis of ZUMA-1, 43% of the Yescarta-treated patients were alive at 5 years, with a median OS of 25.8 months¹. 92% of patients, between the 4- and 5-year analyses, survived without need of further anti-cancer therapy³.
5-year overall survival. Picture adapted from Jacobson et al. 2021³
ZUMA-1: Primary endpoint at 24 months²
In the 24-month follow-up analysis, based on the mITT population (results from an independent review committee), the ORR and the CR rate were 74% and 54%, respectively (ORR [95 % CI] (65–82))²
Safety profile of Yescarta®
Safety data from ZUMA-1 reflects exposure to Yescarta in a Phase 1/2 for 108 patients.¹
The most significant and frequently occurring adverse reactions were CRS (93%), encephalopathy (60%), and infections (40%).
Serious adverse reactions occurred in 51% of patients. The most common (≥ 5%) serious adverse reactions included encephalopathy (22%), unspecified pathogen infections (15%), bacterial infection (6%), viral infection (6%), febrile neutropenia (5%), and fever (5%).¹
Please see the summary of product characteristics for full information on the safety profile of YESCARTA®.
References
- Yescarta Summary of Product Characteristics
- Neelapu SS, Locke FL, Bartlett NL, et al. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med. 2017;377(26):2531-2544.
- Jacobson C, et al. Long-Term (4- and 5-Year) Overall Survival in ZUMA-1, the Pivotal Study of Axicabtagene Ciloleucel (Axi-Cel) in Patients with Refractory Large B-Cell Lymphoma (LBCL). Oral presentation (#1764) presented at the 63rd American Society of Hematology (ASH) Annual Meeting; 11–14 December 2021; Virtual Meeting.
SE-TEC-0032 | 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.
Treatment journey
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