-Author name in bold denotes the presenting author
-Asterisk * with author name denotes a Non-ASH member
Clinically Relevant Abstract denotes an abstract that is clinically relevant.

PhD Trainee denotes that this is a recommended PHD Trainee Session.

Ticketed Session denotes that this is a ticketed session.

1686 Efficacy and Safety of a New Regime Containing PD1 Antibody and Pegaspargase for Advanced-Stage or Relapsed/Refractory Natural Killer/T Cell Lymphoma

Program: Oral and Poster Abstracts
Session: 625. T Cell, NK Cell, or NK/T Cell Lymphomas: Clinical and Epidemiological: Poster I
Hematology Disease Topics & Pathways:
Research, Clinical trials, Clinical Research
Saturday, December 7, 2024, 5:30 PM-7:30 PM

Jie Chen1*, Linjun Zhao2*, Chongyang Wu3*, Haifeng Yu4*, Zhenling Li5*, Lihong Liu6*, Da Gao, MD7*, Ying Sun8*, Xiaolei Wei, MD9*, Yuanbin Wu10*, Yue Wang1*, Yuqin Song, MD11, Jun Zhu, PhD12 and Weiping Liu1*

1Department of Lymphoma, Peking University Cancer Hospital, Beijing, China
2Department of Lymphoma, Peking University International Hospital, Beijing, China
3Lanzhou University Second Hospital, Lanzhou, China
4Department of Lymphatic Oncology, Zhejiang Cancer Hospital, Hangzhou, China
5China-Japan Friendship Hospital, Beijing, China
6Department of Hematology, The Fourth Hospital of Hebei Medical University, Hebei Tumor Hospital, Shijiazhuang, China
7The affiliated hospital of inner mongolia medical univuniversity, Hohhot, China
8Department of Hematology, Chifeng Municipal Hospital, Chifeng, China
9Department of Hematology, Nanfang Hospital of Southern Medical University, Guangzhou, China
10Guangdong Hospital of Traditional Chinese Medicine, Guangzhou, China
11Department of Lymphoma, Peking University Cancer Hospital, BEIJING, China
12Peking University Cancer Hospital, Beijing, China

Background: Patients with advanced-stage or relapsed/refractory (r/r) natural killer/T cell lymphoma (NKTCL) had a poor prognosis. The anti-programmed death 1 (PD-1) antibody has demonstrated satisfactory efficacy and good tolerance for r/r NKTCL. In this report, we present the efficacy and safety analysis of a new regimen containing dexamethasone, azacytidine, pegaspargase, and tislelizumab (named as DAPT) for advanced-stage or r/r NKTCL in a prospective multicenter phase II study.

Methods: Patients with advanced-stage or r/r NKTCL, aged over 18 years, were eligible for participation. The DAPT regimen chemotherapy was administered as the protocol treatment, which included dexamethasone 10 mg on days 1-3, azacytidine 100 mg on days 1-5, pegaspargase 3,750 IU on day 1, and tislelizumab 200 mg on day 6. Cycles were repeated every 21 days. The primary endpoint was the overall response rate (ORR) .

Results: A total of 39 eligible patients were enrolled. The median age of 52 years (range, 32 to 72 years) and with a male-to-female ratio of 2.42:1. Twenty-four (61.5%) patients had newly diagnosed disease with stage IV, while 15 (38.5%) had r/r disease. Among 31 patients with available response, the ORR and complete remission (CR) rates were 77.4% and 33.3% for the entire cohort, 84.2% and 63.6% for newly diagnosed stage IV disease, and 31.6% and 27.3% for r/r disease, respectively. Ten patients underwent autologous hematopoietic stem cell transplantation (ASCT). The median progression-free survival (PFS) was 7.3 months in patients who completed 6 cycles of DAPT therapy. Moreover, the median PFS were 14.0,3.6 and 2.6 months in patients who achieved CR, PR and non-response, respectively. The median PFS was longer in those who achieved ASCT than those who did not experience transplantation (11.5 vs. 2.6 months). The most common treatment-related adverse events were was neutropenia (63.4%), followed by elevated alanine aminotransferase (43.9%), decreased fibrinogen (39.0%) and hypofibrinogenemia (39.0%). The incidence of ≥3 treatment-related adverse events was 26.8%, which included neutropenia (n=8), immune-related rash (n=2), and drug-induced liver injury (n=1) .No treatment-related deaths were observed.

Conclusion: The DAPT regimen chemotherapy is an effective and tolerable treatment for advanced-stage or r/r NKTCL.

Keywords: Lymphoma; Extranodal NK-T-Cell; Immunotherapy; Therapeutics; Prognosis

Disclosures: No relevant conflicts of interest to declare.

OffLabel Disclosure: Tislelizumab, a novel, fully humanized immunoglobulin G4 monoclonal anti-PD-1 antibody, has been granted approval for use in patients with relapsed or refractory classical Hodgkin's lymphoma following at least second-line chemotherapy. This anti-programmed death 1 (PD-1) antibody has exhibited compelling efficacy and a favorable safety profile in the treatment of relapsed/refractory natural killer T-cell lymphoma (r/r NKTCL).

*signifies non-member of ASH