Efficacy and safety of tisagenlecleucel in Japanese adult patients with relapsed/refractory diffuse large B-cell lymphoma.

Abstract

BACKGROUND:

Tisagenlecleucel demonstrated a high rate of durable response in adult patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) in the pivotal global phase 2 JULIET study. Here, we report the efficacy and safety of tisagenlecleucel in the Japanese subgroup.

METHODS:

JULIET (NCT02445248) is a single-arm, open-label, multicenter, phase 2 study involving adult patients with r/r DLBCL who either relapsed after or were ineligible for autologous stem cell transplant. Primary endpoint was best overall response rate (ORR; complete response [CR] + partial response [PR]) as judged by an independent review committee.

RESULTS:

In Japan, of 17 patients enrolled, 9 were infused with tisagenlecleucel and completed ≥ 3 months of follow-up. Best ORR was 77.8% (7/9; 95% confidence interval, 40.0-97.2), with 5 patients (55.6%) in CR and 2 (22.2%) in PR. Cytokine release syndrome (CRS) occurred in 6 patients (66.7%), with grade 3 CRS in 2 patients (Penn grading scale). Two patients received tocilizumab. Two deaths (22.2%) occurred more than 30 days after tisagenlecleucel infusion due to disease progression, neither of which were related to tisagenlecleucel.

CONCLUSION:

Tisagenlecleucel showed a high best ORR with a manageable safety profile, thus offering a new treatment option in selected Japanese patients with r/r DLBCL.

• Authors: Hideki Goto, Shinichi Makita, Koji Kato, Kota Tokushige, Taizo Fujita, Koichi Akashi, Koji Izutsu, Takanori Teshima
• Journal: International journal of clinical oncology (Int J Clin Oncol) Vol. 25 Issue 9 Pg. 1736-1743 (Sep 2020) ISSN: 1437-7772 [Electronic] Japan
• PMID: 32448949 (Publication Type: Clinical Trial, Phase II, Journal Article)

Chemical References

• Antibodies, Monoclonal, Humanized
• Antineoplastic Agents, Immunological
• Cytokines
• Receptors, Antigen, T-Cell
• tocilizumab
• tisagenlecleucel

Topics

• Adult
• Aged
• Antibodies, Monoclonal, Humanized (therapeutic use)
• Antineoplastic Agents, Immunological (adverse effects, therapeutic use)
• Asian People
• Cytokines (blood)
• Female
• Humans
• Lymphoma, Large B-Cell, Diffuse (drug therapy, pathology)
• Male
• Middle Aged
• Receptors, Antigen, T-Cell (therapeutic use)
• Treatment Outcome