As reported in the Journal of Clinical Oncology by Maziarz et al, 5-year analysis of the pivotal phase II JULIET trial has shown maintained efficacy of tisagenlecleucel in patients with relapsed or refractory large B-cell lymphoma.
Study Details
In the trial, 115 patients received tisagenlecleucel infusion. The current report provides outcomes as of the last patient visit in December 2022, with a median follow-up of 74.3 months (range = 58.1–86.6 months).
Key Findings
Objective response was observed in 61 patients (53.0%), with 45 (39.1%) achieving complete response. Conversion from partial to complete response occurred in 19 patients, with conversion occurring in 15 within 6 months after infusion; however, conversion was also observed in patients at as long as 24 and 33 months after infusion. Median duration of response was not reached.
Among responders, 60-month relapse-free probability was 61%. Longer relapse-free probability (> 70% at 5 years) was observed in female responders, responders with fewer than two baseline International Prognostic Index risk factors, and those with baseline stage I or II disease. Progression-free survival at 60 months was 28%. Median overall survival was 11.1 months among all patients and 76.5 months among responders. Overall survival at 60 months was 31.7% among all patients and 55.8% among responders.
Baseline characteristics associated with achieving response at any time after infusion included relapsed vs refractory disease, one vs two or more bridging regimens, lactate dehydrogenase (LDH) levels ≤ upper limit of normal (ULN) vs > ULN, and C-reactive protein levels < 15 mg/L vs > 15 mg/L. Baseline characteristics associated with longer overall survival included LDH ≤ ULN and C-reactive protein < 15 mg/L.
No new safety signals or secondary T-cell malignancies were reported.
The investigators concluded: “These findings continue to support the curative potential of tisagenlecleucel in a subset of patients with [relapsed or refractory large B-cell lymphoma].”
Richard T. Maziarz, MD, of Oregon Health and Science University Knight Cancer Institute, Portland, Oregon, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Novartis and a grant from the National Cancer Institute. For full disclosures of all study authors, visit ascopubs.org.
