2021 EHA blockbuster Naratuximab emtansine + rituximab in the treatment of DLBCL and other B-NHL safety and efficacy exploration

Naratuximab emtansine (nara) is an antibody drug conjugate
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In preclinical studies of B-cell non-Hodgkin's lymphoma (B-NHL), nara showed strong anti-tumor activity, and the activity was further enhanced by the combined use of rituximab (RTX)
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Professor Moshe Yair Levy from the United States and others conducted a phase 2 study to evaluate the safety of nara+RTX in the treatment of relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and other B-NHL patients Sex and efficacy
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The study was selected for the Late-Breaking Abstracts (LBA) of the 26th European Hematology Annual Conference (2021 EHA)
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The editor organizes its main content as follows for the reference of readers
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1 Research methods R/R B-NHL patients who have previously received 1-6 lines of treatment and are not suitable for hematopoietic stem cell transplantation were recruited into two parts of the study
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In the first part of the safety assessment and expansion of the cohort, patients received 0.
7mg/kg nara+375mg/m2 RTX every 3 weeks (Q3W)
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Part 2 included only R/R DLBCL patients, and the patients received Q3W regimen + 375mg/m2 RTX treatment (cohort A), or received 0.
4, 0.
2, and 0.
2 mg/kg nara on days 1, 8 and 15 respectively Weekly program +375mg/m2 RTX treatment (cohort B)
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The main study endpoints are adverse events (TEAE) and overall response rate (ORR) during treatment
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All patients reported safety, and only DLBCL patients reported efficacy
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The follow-up period was until 1 year after the first administration of the last patient in the group
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2 Results of the study 100 patients were included in the study: 80 DLBCL and 20 other B-NHL patients, of which 81 (81%) had ≥ grade 3 TEAE, the most common being neutropenia (54%), Leukopenia (19%), lymphopenia (17%) and thrombocytopenia (12%)
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8 (8%) patients discontinued nara treatment due to TEAE
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Only a very small number of TEAEs ≥3 grades have been reported, known to be related to free DM1: 3 cases (3%) of patients had liver events (1 case of toxic hepatitis, 1 case of elevated glutamyltransferase [GGT], 1 case of alkali Elevated sex phosphatase [ALP]) without sequelae; 2 patients (2%) developed neuropathy (1 motor-related and 1 sensory-related)
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Among 80 DLBCL patients, 10 (12.
5%) patients were primary refractory, 24 (30%) patients were terminal refractory, 62 (78%) patients were Ann Arbor III/IV, 35 Cases (44%) had received at least 2 lines of treatment in the past
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The efficacy can be evaluated in 76 patients, with an ORR of 44.
7%, of which 24 (31.
6%) patients achieved complete remission (CR), and 10 (13.
2%) patients achieved partial remission
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In addition, 9 patients (11.
8%) had stable disease and 33 (43.
4%) patients had disease progression
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The efficacy of 30 patients in each of the two main cohorts (A and B) can be evaluated, and the ORR of both cohorts is 50% (CR rate: cohort A is 43.
3%; cohort B is 33.
3%)
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The median duration of response in 76 patients with DLBCL did not reach (the lower limit of 95% CI was 12 months)
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The median follow-up duration for remission patients was 15 months
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3 Research conclusions Nara+RTX treatment has higher ORR and CR rates, long-lasting remission, controllable safety, and complete CD37 target binding
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Therefore, nara+RTX can be considered as a better treatment option for R/R DLBCL
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Reference source: Moshe Yair Levy, SAFETY AND EFFICACY OF CD37-TARGETING NARATUXIMAB EMTANSINE PLUS RITUXIMAB IN DIFFUSE LARGE B-CELL LYMPHOMA AND OTHER NON-HODGKIN'S B-CELL LYMPHOMAS-A PHASE 2 STUDY.
2021 EHA3 Annual Meeting.
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