This study compared the efficacy, safety and immunogenicity of ripertamab (SCT400) and rituximab (Mabthera®) combined with CHOP as the first‐line treatment for Chinese patients with CD20‐positive diffuse large B cell lymphoma (DLBCL). This is a randomized, patient‐blind, multicenter, active‐control, non‐inferiority study with parallel design. Patients were randomly (2:1) to receive ripertamab combined with CHOP (S‐CHOP) or rituximab (Mabthera®) combined with CHOP (R‐CHOP) for up to 6 cycles. The primary endpoint was the Independent Review Committee (IRC) assessed objective response rate (ORR) in full analysis set (FAS) and the per protocol set (PPS). A total of 364 patients (243 in the S‐CHOP and 121 in the R‐CHOP groups) were enrolled in this study. In FAS, IRC‐assessed ORRs were 93.8% (95% confidence interval (CI) 90.0%, 96.5%) and 94.2% (95% CI: 88.4%, 97.6%) in the S‐CHOP and R‐CHOP groups (p = 0.9633), respectively. The ORR difference between the two groups −0.4% (95% CI: −5.5%, 4.8%) met the pre‐specified non‐inferiority margin of −12%. There were no significant differences between the S‐CHOP and R‐CHOP groups in 1‐year progression‐free survival rates (81.1% vs. 83.2%, p = 0.8283), 1 year event‐free survival rates (56.2% vs. 58.1%, p = 0.8005), and 3‐year overall survival rates (81.0% vs. 82.8%, p = 0.7183). The results in PPS were consistent with those in FAS. The rates of treatment‐emergent adverse events (TEAEs) and ≥ grade 3 TEAEs were 97.9% and 99.2%, 85.2% and 86.0% in the S‐CHOP and R‐CHOP groups, respectively in safety set. The percentage of anti‐drug antibodies positive patients in the S‐CHOP group was numerically lower than the R‐CHOP group (10.9% vs. 16.0%). This study demonstrated that S‐CHOP was not inferior to R‐CHOP in the first‐line treatment of Chinese patients with CD20‐positive DLBCL in efficacy, safety and immunogenecity. S‐CHOP could be an alternative first‐line standard treatment regimen for this patient population.
Extranodal natural killer/T cell lymphoma (ENKTL) patients typically face a grim prognosis after relapse or progression following asparaginase‐based chemotherapy. Currently, programmed cell death protein‐1 (PD‐1) immune checkpoint blockade has shown promising efficacy as an optimal regimen for relapsed or refractory ENKTL (rrENKTL) patients. This study retrospectively investigated the efficacy, safety, and factors influencing the survival of 26 rrENKTL patients who underwent monoclonal antibody treatment using PD‐1 (Sintilimab or Camrelizumab) alone or combined with chemotherapy from January 2018 to February 2022. The disease control rate was 73.1%, and the objective response rate was 50.0%. 15.4% of the patients achieved complete remission, and 34.6% achieved partial remission (PR). After a median follow‐up of 12 (range 3–47) months, the median progression‐free survival (PFS) and overall survival (OS) were 6.5 and 13.3 months. The 1‐year PFS and OS rate were 23.1% and 53.8%. 96.2% of patients experienced at least one adverse event and 26.9% experienced grade 1–2 immune‐related adverse events. PD‐1 inhibitor improved rrENKTL patient survival, and the AEs were controlled. We also observed that the prognostic index for NK cell lymphoma including Epstein‐Barr virus (EBV) (PINK‐E) and the nomogram‐revised risk indexz for ENKTL patients could help identify a potentially unfavorable prognosis in this era of immunotherapy. More attention should be paid to the presence of EBV after anti‐PD‐1 immunotherapy, as it more accurately indicates a poor prognosis.
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