Session: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster I
Hematology Disease Topics & Pathways:
Combination therapy, Therapies
Methods: This was a prospective, multicenter, single-arm, open-label, phase II study (ChiCTR2200056256). Patients aged 18 to 75 years were eligible if they had histologically confirmed R/R DLBCL, an Eastern Cooperative Oncology Group performance status of 0-2, adequate organ and bone marrow function, and survival time ≥ 6 months. Eligible patients received a combination regimen (21-day/cycle) of lenalidomide (10-25 mg, days 1-10, QD, oral), Tislelizumab (200 mg, day 1, intravenous), and orelabrutinib (150 mg, QD, oral) or rituximab (375 mg/m2, day 1, intravenous). The primary endpoint was ORR. Secondary endpoints included complete response (CR), progression-free survival (PFS), duration of response (DOR), time to response (TTR) and adverse events (AEs). Efficacy was assessed using Lymphoma Response to Immunomodulatory therapy Criteria (LYRIC, 2016). AEs were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) v 4.0.
Results: Between August 2021 and March 2022, 9 patients (6 males; median age, 73 years, range 65-76) were enrolled. Among them, 8 patients were non-germinal center B-cell-like and 1 was unknown. Most patients had comorbidities (n=8, 88.9%), an Ann Arbor stage of III or IV (n=4, 44.4%), International Prognostic Index (IPI) ≥ 3 (n=4, 44.4%). All patients received lenalidomide, anti-PD-1 antibody combined with orelabrutinib regimen, and the median duration of treatment was 5 cycles (range 3-6). Among them, 4 patients (44.4%) received a second-line therapy, and 5 patients (55.5%) received ≥ third-line therapy. Before enrollment, 3 patients attained a CR as their best response during the previous therapies. Eight patients were included in the efficacy analysis. The ORR, CR and median TTR were 87.5%, 25.0%, and 2.45 months (range 1.97-2.73), respectively. Among them, 3 patients completed 6 cycles of therapy with ORR of 100% (Figure 1). The PFS and DOR were not completely mature due to the short follow-up period at the end of follow-up. Eight (80%) patients reported AEs. The most common hematological AEs were anemia (77.8%), platelet count reduced (55.6%), neutrophil count decreased (33.3%) and white blood cell count decreased (22.2%). Three patients (33.3%) discontinued treatment due to AEs (atrioventricular block, n=1; rash, n=2). In addition, the most common AEs were grade 1 or 2, and no grade 4 AEs. One patient died due to electrolyte disturbances and depression.
Conclusion: Lenalidomide, anti-PD-1 antibody combined with orelabrutinib or rituximab regimen is effective and well-tolerated for patients with R/R DLBCL in this phase II study. This study provides a potential novel strategy for the treatment of R/R DLBCL.
Disclosures: No relevant conflicts of interest to declare.
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