Long-term outcome of patients with relapsed/refractory B-cell non-Hodgkin lymphoma treated with blinatumomab
Autor: | Vera Dufner, Horst D. Hummel, Ralf C. Bargou, Maria-Elisabeth Goebeler, Cyrus Sayehli, Götz Gelbrich, Manik Chatterjee |
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Rok vydání: | 2019 |
Předmět: |
Adult
Male 0301 basic medicine Oncology medicine.medical_specialty Lymphoma B-Cell Clinical Trials and Observations 03 medical and health sciences Antineoplastic Agents Immunological 0302 clinical medicine Refractory Recurrence hemic and lymphatic diseases Internal medicine Antibodies Bispecific medicine Humans Adverse effect Aged Aged 80 and over business.industry Lymphoma Non-Hodgkin Hematology Middle Aged medicine.disease Lymphoma Cytokine release syndrome Treatment Outcome 030104 developmental biology Drug Resistance Neoplasm 030220 oncology & carcinogenesis Retreatment Toxicity B-Cell Non-Hodgkin Lymphoma Female Blinatumomab business Burkitt's lymphoma medicine.drug |
Zdroj: | Blood Advances. 3:2491-2498 |
ISSN: | 2473-9537 2473-9529 |
Popis: | Blinatumomab, the first-in-class CD3/CD19 bispecific T-cell engager antibody construct, has recently been approved for treating patients with relapsed or refractory (R/R) B-cell acute lymphoblastic leukemia. However, the clinical proof of concept of blinatumomab efficacy was initially demonstrated in patients with R/R B-cell non-Hodgkin lymphoma (B-NHL) in the MT103-104 phase 1 dose-escalation and expansion trial (NCT00274742), which defined 60 µg/m2 per day as the maximum tolerated dose (MTD). The clinically most relevant adverse effects were neurologic symptoms and cytokine release syndrome. Currently, there are no data on long-term outcomes and toxicity for B-NHL patients receiving blinatumomab treatment, so we performed a single-center, long-term follow-up analysis of 38 patients who participated in the MT103-104 phase 1 trial. We found no evidence for long-term toxicities, especially no blinatumomab-induced neurocognitive impairments. For the entire study population, the median overall survival (OS) was 4.6 years. Remarkably, patients who had received ≥60 µg/m2 per day and responded to blinatumomab achieved a median OS of 7.7 years. Of note, 6 of the surviving patients treated at the MTD have been treatment-free for more than 7 years. In contrast, patients who were treated at dose levels below the MTD had a median OS of only 1.1 years. These results indicate that 60 µg/m2 per day seems to represent the targeted dose level of blinatumomab required for durable remission in R/R B-NHL. Here, we provide the first clinical evidence that blinatumomab lacks long-term toxicity and has the potential to induce sustained remissions in patients with R/R B-NHL. |
Databáze: | OpenAIRE |
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