Prolonged Improvement in Patient Reported Quality of Life (QoL) Following Tisagenlecleucel Infusion in Adult Patients (pts) with Relapsed/Refractory (r/r) Diffuse Large B-Cell Lymphoma (DLBCL): 19-Month Follow-up (FU) of the Juliet Study

Background

Quality of life (QoL) is an important endpoint in the JULIET study (NCT02445248), a phase 2 trial evaluating a single infusion of tisagenlecleucel in adult patients (pts) with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL). Earlier analyses showed improvements in QoL at month (mo) 3 and 6 (Maziarz et al, ASH 2017, EBMT 2018). We report updated JULIET data with extended follow-up (FU; median: 19.3 mo).

Methods

Pts were aged ≥18 years with r/r DLBCL after ≥2 lines of therapy and either failed or were ineligible for autologous hematopoietic stem cell transplant (SCT). At baseline, mo-3 through mo-24, pts completed the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) and Short Form-36 Health Survey v2 (SF-36). Higher scores indicate better QoL.

Results

Of the 167 enrolled pts, 115 pts were infused with tisagenlecleucel before data cutoff; 96% had previously received ≥2 systemic therapies and 49% had relapsed after SCT. QoL instruments were completed by 108 pts (94%) at baseline, including 50 patients who had complete response (CR) or partial response (PR). Of pts eligible for analysis with CR or PR, 26 and 21 completed the assessments at mo-12 and -18, respectively. Scores of pts with CR or PR (mean change at baseline through mo-18) indicated sustained improvements in all categories (Table 1). Similar trends were observed for SF-36.

Conclusions

With long term FU, pts with r/r DLBCL responding to tisagenlecleucel continue to show sustained improvements in QoL.