EHA 2018 | Updated results from the phase II JULIET trial of tisagenlecleucel in patients with R/R DLBCL

On Saturday 16^th June an oral abstract session took place at the 23^rd Congress of the European Hematology Association (EHA). Abstract S799 was presented by Peter Borchmann, University Hospital of Cologne, Germany, on the updated analysis of the JULIET study of tisagenlecleucel in adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

Tisagenlecleucel was the first CAR-T therapy to be approved in the United States. In May 2018, tisagenlecleucel was approved by the US Food and Drug Administration for adult patients with DLBCL after 2 or more lines of therapy. The approval was supported by data from the JULIET study. Updated results from the JULIET study were presented during this session. The primary endpoint was best overall response (ORR) using the Lugano criteria by an independent review committee. Secondary endpoints included duration of response (DOR), overall survival (OS) and safety.

Study Overview

• Patients with DLBCL was 79%. 55% of the patients were refractory to last therapy and 45% relapsed
• Out of N = 111 patients, the percentage of neurological events Grade 3 was 7% and Grade 4 was 5%. Cytokine release syndrome (CRS) Grade 3 was 14% and 4 was 8%
• There were no deaths due to tisagenlecleucel, CRS or cerebral edema

Key Findings

• The ORR was consistent across subgroups = 52% (95% CI, 41%-62%); 40% complete response and 12% partial response
• At 14 months median follow-up the median DOR was not reached
• The 12-month relapse-free survival rate was 78.5% (95% CI, 60%-89%) among patients with a complete response and 65% (95% CI, 49%-78%) among all responders
• For patients with a complete response, the median OS was not reached and for all patients, the OS was 11.7 months (95% CI, 6.6-not reached)

In addition to these results, it was also found that baseline tumor volume, LDH, ferritin, and CRP were associated with higher risk of any-grade CRS and neurotoxicity. Dr Borchmann concluded that tisagenlecleucel produced high durable responses in patients with R/R DLBCL.