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Long‐term survival of patients with relapsed/refractory acute lymphoblastic leukemia treated with blinatumomab
Author(s) -
Topp Max S.,
Gökbuget Nicola,
Zugmaier Gerhard,
Stein Anthony S.,
Dombret Hervé,
Chen Yuqi,
Ribera JosepMaria,
Bargou Ralf C.,
Horst HeinzAugust,
Kantarjian Hagop M.
Publication year - 2021
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.33298
Subject(s) - blinatumomab , medicine , refractory (planetary science) , cumulative incidence , hematopoietic stem cell transplantation , gastroenterology , acute lymphocytic leukemia , confidence interval , lymphoblastic leukemia , transplantation , oncology , surgery , leukemia , physics , astrobiology
Background Blinatumomab is a CD19 BiTE (bispecific T‐cell engager) immuno‐oncology therapy that mediates the lysis of cells expressing CD19. Methods A pooled analysis of long‐term follow‐up data from 2 phase 2 studies that evaluated blinatumomab in heavily pretreated adults with Philadelphia chromosome–negative, relapsed/refractory B‐cell precursor acute lymphoblastic leukemia was conducted. Results A total of 259 patients were included in the analysis. The median overall survival (OS) among all patients, regardless of response, was 7.5 months (95% confidence interval [CI], 5.5‐8.5 months); the median follow‐up time for OS was 36.0 months (range, 0.3‐60.8 months). The median relapse‐free survival (RFS) among patients who achieved a complete remission (CR) or complete remission with partial hematologic recovery (CRh) in the first 2 cycles (n = 123) was 7.7 months (95% CI, 6.2‐10.0 months); the median follow‐up time for RFS was 35.0 months (range, 9.5‐59.5 months). OS and RFS plateaued with 3‐year rates of 17.7% and 23.4%, respectively. The cumulative incidence function of the time to relapse, with death not due to relapse considered a competing risk, for patients who achieved a CR/CRh within 2 cycles of treatment also plateaued with a 3‐year relapse rate of 59.3%. For patients who achieved a CR/CRh with blinatumomab followed by allogeneic hematopoietic stem cell transplantation while in continuous CR, the median OS was 18.1 months (95% CI, 10.3‐30.0 months) with a 3‐year survival rate of 37.2%. Conclusions These data suggest that long‐term survival is possible after blinatumomab therapy. Lay Summary Immuno‐oncology therapies such as blinatumomab activate the patient's own immune system to kill cancer cells. This study combined follow‐up data from 2 blinatumomab‐related clinical trials to evaluate long‐term survival in patients with relapsed and/or refractory B‐cell precursor acute lymphoblastic leukemia at high risk for unfavorable outcomes. Among patients who achieved a deep response with blinatumomab, one‐third lived 3 years or longer. These findings suggest that long‐term survival is possible after treatment with blinatumomab.