LONG-TERM OUTCOME OF PATIENTS WITH RELAPSED/REFRACTORY B-CELL NON- HODGKIN LYMPHOMA TREATED WITH BISPECIFIC ANTIBODY BLINATUMOMAB IN A PHASE I TRIAL

2019 ◽  
Vol 37 ◽  
pp. 325-326
Author(s):  
V. Dufner ◽  
C. Sayheli ◽  
G. Gelbrich ◽  
R. Bargou ◽  
M. Goebeler
2019 ◽  
Vol 3 (16) ◽  
pp. 2491-2498 ◽  
Author(s):  
Vera Dufner ◽  
Cyrus M. Sayehli ◽  
Manik Chatterjee ◽  
Horst D. Hummel ◽  
Götz Gelbrich ◽  
...  

Abstract 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.


2014 ◽  
Vol 32 (15_suppl) ◽  
pp. 8524-8524 ◽  
Author(s):  
Owen A. O'Connor ◽  
Changchun Deng ◽  
Jennifer Effie Amengual ◽  
Mazen Y. Khalil ◽  
Marshall T. Schreeder ◽  
...  

2009 ◽  
Vol 27 (3) ◽  
pp. 942-945 ◽  
Author(s):  
Dilek Dincol ◽  
Abdullah Buyukcelik ◽  
Mutlu Dogan ◽  
Hakan Akbulut ◽  
Mustafa Samur ◽  
...  

2012 ◽  
Vol 12 (6) ◽  
pp. 406-411 ◽  
Author(s):  
Nishitha Reddy ◽  
Olalekan Oluwole ◽  
John P. Greer ◽  
Stacey Goodman ◽  
Brian Engelhardt ◽  
...  

2013 ◽  
Vol 88 (7) ◽  
pp. 589-593 ◽  
Author(s):  
Thomas E. Witzig ◽  
Gregory A. Wiseman ◽  
Matthew J. Maurer ◽  
Thomas M. Habermann ◽  
Ivana N.M. Micallef ◽  
...  

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