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
Giovanni Martinelli, Nicolas Boissel, Patrice Chevallier, Oliver Ottmann, Nicola Gökbuget, Alessandro Rambaldi, Ellen K Ritchie, Cristina Papayannidis, Catherine A Tuglus, Joan D Morris, Anthony Stein, Giovanni Martinelli, Nicolas Boissel, Patrice Chevallier, Oliver Ottmann, Nicola Gökbuget, Alessandro Rambaldi, Ellen K Ritchie, Cristina Papayannidis, Catherine A Tuglus, Joan D Morris, Anthony Stein
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.
Keywords: Acute lymphoblastic leukaemia; Bispecific T-cell engager (BiTE®); Blinatumomab; Philadelphia chromosome–positive.
Conflict of interest statement
Conflict of interest statement The authors declare the following financial interests/personal relationships, which may be considered as potential competing interests: Giovanni Martinelli declares no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper; Nicolas Boissel declares research funding and honoraria from Amgen; Patrice Chevallier reports honorarium from Amgen; Oliver Ottmann declares honoraria for advisory boards and research funding from Amgen, Incyte and Celgene, and honoraria for advisory boards from Roche, Fusion Pharma and Novartis; Nicola Gökbuget declares research support and honoraria from Amgen, Novartis and Pfizer, and is on advisory board of Amgen, Novartis and Pfizer; Alessandro Rambaldi reports personal fees from Amgen, Pfizer, Novartis, Kite Gilead, Celgene BMS, Astellas and Sanofi; Ellen K. Ritchie reports research support from Jazz and Pfizer, consulting fee from Celgene and Novartis, and is on speakers bureau and ad board of Incyte; Cristina Papayannidis reports honoraria from Amgen, Pfizer, Janssen, AbbVie and Novartis; Catherine Tuglus is an Amgen employee and holds Amgen stock; Joan Morris is an Amgen employee; Anthony Stein is on speakers bureau and advisory board of Amgen and Stemline.
Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.
Source: PubMed