TY - JOUR
T1 - Blinatumomab as first salvage versus second or later salvage in adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia
T2 - Results of a pooled analysis
AU - Topp, Max S.
AU - Stein, Anthony S.
AU - Gökbuget, Nicola
AU - Horst, Heinz August
AU - Boissel, Nicolas
AU - Martinelli, Giovanni
AU - Kantarjian, Hagop
AU - Brüggemann, Monika
AU - Chen, Yuqi
AU - Zugmaier, Gerhard
N1 - Funding Information:
Hagop Kantarjian: received research funding from AbbVie, Agios, Amgen Inc., Ariad, Astex, Bristol‐Myers Squibb, Cyclacel, Daiichi‐Sankyo, ImmunoGen, Jazz Pharmaceuticals, Novartis, and Pfizer; and received honoraria from AbbVie, Actinium, Agios, Amgen Inc., Pfizer, and Takeda.
Funding Information:
This work was funded by Amgen Inc. Medical writing support was provided by Ben Scott (Scott Medical Communications, LLC) and Advait A. Joshi, PhD (Cactus Life Sciences––part of Cactus Communications) and was funded by Amgen Inc.
Funding Information:
Heinz‐August Horst: received research funding, travel support from, and participated in advisory boards for Amgen Inc.; participated in advisory board for Pfizer, Jazz Pharmaceuticals, and Novartis; and received research funding from Regeneron.
Funding Information:
Monika Brüggemann: received consulting fees and honoraria from Amgen Inc., Celgene, Incyte, Janssen, and Roche, and research funding from Affimed, Regeneron, and Roche.
Publisher Copyright:
© 2021 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
PY - 2021/4
Y1 - 2021/4
N2 - Background: Blinatumomab is a BiTE® immuno-oncology therapy indicated for the treatment of patients with relapsed or refractory (r/r) B-cell precursor (BCP) acute lymphoblastic leukemia (ALL). Aims To assess the efficacy and safety of blinatumomab as first salvage versus second or later salvage in patients with r/r BCP ALL. Materials & Methods Patient-level pooled data were used for this analysis. In total, 532 adults with r/r BCP ALL treated with blinatumomab were included (first salvage, n = 165; second or later salvage, n = 367). Results Compared with patients who received blinatumomab as second or later salvage, those who received blinatumomab as first salvage had a longer median overall survival (OS; 10.4 vs. 5.7 months; HR, 1.58; 95% CI, 1.26–1.97; P <.001) and relapse-free survival (10.1 vs. 7.3 months; HR, 1.38; 95% CI, 0.98–1.93; P =.061), and higher rates of remission (n = 89 [54%] vs. n = 150 [41%]; odds ratio, 0.59; 95% CI, 0.41–0.85; P =.005), minimal residual disease response (n = 68 [41%] vs. n = 118 [32%]), and allogeneic hematopoietic stem cell transplant (alloHSCT) realization (n = 60 [36%] vs. n = 88 [24%]), and alloHSCT in continuous remission (n = 33 [20%] vs. n = 52 (14%]). In a subgroup analysis, there was no apparent effect of prior alloHSCT on median OS in either salvage group. The safety profile of blinatumomab was generally similar between the groups; however, cytokine release syndrome, febrile neutropenia, and infection were more frequent with second or later salvage than with first salvage. Discussion In this pooled analysis, the logistic regression analyses indicated greater benefit with blinatumomab as first salvage than as second or later salvage, as evident by the longer median OS, longer median RFS, and higher rates of remission. Conclusion Overall, blinatumomab was beneficial as first salvage and as second or later salvage, but the effects were favorable as first salvage.
AB - Background: Blinatumomab is a BiTE® immuno-oncology therapy indicated for the treatment of patients with relapsed or refractory (r/r) B-cell precursor (BCP) acute lymphoblastic leukemia (ALL). Aims To assess the efficacy and safety of blinatumomab as first salvage versus second or later salvage in patients with r/r BCP ALL. Materials & Methods Patient-level pooled data were used for this analysis. In total, 532 adults with r/r BCP ALL treated with blinatumomab were included (first salvage, n = 165; second or later salvage, n = 367). Results Compared with patients who received blinatumomab as second or later salvage, those who received blinatumomab as first salvage had a longer median overall survival (OS; 10.4 vs. 5.7 months; HR, 1.58; 95% CI, 1.26–1.97; P <.001) and relapse-free survival (10.1 vs. 7.3 months; HR, 1.38; 95% CI, 0.98–1.93; P =.061), and higher rates of remission (n = 89 [54%] vs. n = 150 [41%]; odds ratio, 0.59; 95% CI, 0.41–0.85; P =.005), minimal residual disease response (n = 68 [41%] vs. n = 118 [32%]), and allogeneic hematopoietic stem cell transplant (alloHSCT) realization (n = 60 [36%] vs. n = 88 [24%]), and alloHSCT in continuous remission (n = 33 [20%] vs. n = 52 (14%]). In a subgroup analysis, there was no apparent effect of prior alloHSCT on median OS in either salvage group. The safety profile of blinatumomab was generally similar between the groups; however, cytokine release syndrome, febrile neutropenia, and infection were more frequent with second or later salvage than with first salvage. Discussion In this pooled analysis, the logistic regression analyses indicated greater benefit with blinatumomab as first salvage than as second or later salvage, as evident by the longer median OS, longer median RFS, and higher rates of remission. Conclusion Overall, blinatumomab was beneficial as first salvage and as second or later salvage, but the effects were favorable as first salvage.
KW - BiTE
KW - acute lymphoblastic leukemia
KW - blinatumomab
KW - salvage
KW - stem cell transplant
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U2 - 10.1002/cam4.3731
DO - 10.1002/cam4.3731
M3 - Article
C2 - 33734596
AN - SCOPUS:85102712157
SN - 2045-7634
VL - 10
SP - 2601
EP - 2610
JO - Cancer medicine
JF - Cancer medicine
IS - 8
ER -