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Long-term follow-up of blinatumomab in patients with relapsed/refractory Philadelphia chromosome-positive B-cell precursor acute lymphoblastic leukaemia: final analysis of ALCANTARA study

Martinelli, Giovanni, Boissel, Nicolas, Chevallier, Patrice, Ottmann, Oliver, Gökbuget, Nicola, Rambaldi, Alessandro, Ritchie, Ellen K., Papayannidis, Cristina, Tuglus, Catherine A., Morris, Joan D. and Stein, Anthony 2021. Long-term follow-up of blinatumomab in patients with relapsed/refractory Philadelphia chromosome-positive B-cell precursor acute lymphoblastic leukaemia: final analysis of ALCANTARA study. European Journal of Cancer 146 , pp. 107-114. 10.1016/j.ejca.2020.12.022

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Abstract

Aim To evaluate long-term durability of blinatumomab, a BiTE® (bispecific T-cell engager) molecule, in adults with relapsed/refractory (R/R) Philadelphia chromosome–positive (Ph+) B-cell precursor acute lymphoblastic leukaemia (ALL). Methods In this final analysis of an open-label, single-arm, phase 2, multicentre ALCANTARA study (NCT02000427), adults (age ≥18 years) with Ph+ ALL who had relapsed or were refractory to at least one TKI were included. The primary endpoint was the proportion of patients who achieved complete remission (CR)/CR with partial haematologic recovery (CRh) during the first two cycles of blinatumomab treatment. Results The final analysis included 45 patients who completed the study between 3rd January 2014 and 6th January 2017, of which 16 (35.6%; 95% CI, 21.9%–51.2%) achieved CR/CRh within the first two blinatumomab cycles. After a median follow-up of 16.1 months, median relapse-free survival (RFS) was 6.8 (95% CI, 4.4–not estimable [NE]) months. Median overall survival (OS) was 9.0 (95% CI, 5.7–13.5) months with a median follow-up of 25.1 months. Median OS in patients with CR (19.8 [95% CI, 12.1–NE] months) was greater than in those without CR (6.0 [95% CI, 2.9–7.1] months). Of 16 patients with CR/CRh, 14 achieved complete minimal residual disease (MRD) response; the median duration of complete MRD response was 9.7 (95% CI, 5.2–NE) months. Treatment-related adverse events were consistent with those previously reported. Conclusion Long-term durability of responses to blinatumomab was demonstrated in patients with R/R Ph+ ALL.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Additional Information: This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
Publisher: Elsevier
ISSN: 0959-8049
Date of First Compliant Deposit: 5 March 2021
Date of Acceptance: 14 December 2020
Last Modified: 08 Mar 2021 11:00
URI: https://orca.cardiff.ac.uk/id/eprint/139330

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