CAR T Cell Therapy May Yield Durable Response in Relapsed/Refractory Diffuse Large B Cell Lymphoma

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Over half of evaluable patients who received an infusion of tisagenlecleucel achieved partial or complete response.
Over half of evaluable patients who received an infusion of tisagenlecleucel achieved partial or complete response.

A single infusion of tisagenlecleucel, an anti-CD19 chimeric antigen receptor (CAR) T cell therapy, yielded high, durable response rates in patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), according to a report published in The New England Journal of Medicine.

The JULIET trial (ClinicalTrials.gov Identifier: NCT02445248) is an active, open label, international phase 2 study of tisagenlecleucel for relapsed or refractory DLBCL in adults who had previously received at least 2 types of therapy. Patients who had follicular lymphoma-transformed DLBCL and double- or triple-hit lymphoma were also included. The primary endpoint was best overall response rate.

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Of the 111 patients who received a tisagenlecleucel infusion, 93 were included in the efficacy evaluation. The overall median dose was 3.0 x 108 viable CAR-positive T cells (range, 0.1 x 108-6.0 x 108). The median time from infusion to the data cutoff date was 14 months (range, 0.1-26). The best overall response rate was 52% (95% CI: 41%-62%), with 40% (37/93) of patients exhibiting complete response and 12% (11/93) exhibiting partial response.

The median response duration had not yet been achieved at the time of publication. The estimated rate of relapse-free survival at 1 year was 65% (95% CI: 49%-78%) for patients who had a response and 79% (95% CI: 60%-89%) for patients with complete response. For patients who were in remission 3 months after infusion, the estimated probability of remaining in remission after 1 year was 81% (95% CI: 63%-91%).

Grade 3 or 4 adverse events suspected of being related to the study drug included cytokine release syndrome (22%, 25/111), neurologic events (12%, 13/111), cytopenias that persisted for more than 28 days (32%, 36/111), infections (20%, 22/111), and febrile neutropenia (14%, 16/111).

The authors concluded that tisagenlecleucel offered a possible treatment alternative for patients with relapsed or refractory DLBCL who may have few treatment options, and that larger studies with longer follow-up periods are needed.

Disclosure: This study was sponsored by Novartis. Please refer to the original reference for a complete list of the authors' disclosures.

Reference

1. Schuster SJ, Bishop MR, Tam CS, et al. Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma [published online December 1, 2018]. N Engl J Med. doi: 10.1056/NEJMoa1804980

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