Blinatumomab in de novo AYA ALL-Results of the Australasian Leukaemia and Lymphoma Group ALL09 &quot;SUBLIME&quot; study

Greenwood, M; Gangatharan, S; Osborn, M; Ng, AP; Fleming, S; Fedele, P; Trahair, T; Casey, J; Mapp, S; Cheung, C; Armytage, T; Henderson, M; Sutton, R; Rehn, J; Page, E; Heatley, S; Button, P; Rowley, L; Larsen, SR; Presgrave, P; Kwan, J; Bennett, S; Fong, CY; Dalla Pozza, L; Yeung, D; White, D; Australasian Leukaemia and Lymphoma Group

Blinatumomab in de novo AYA ALL-Results of the Australasian Leukaemia and Lymphoma Group ALL09 "SUBLIME" study

Author(s): Greenwood, M; Gangatharan, S; Osborn, M; Ng, AP; Fleming, S; Fedele, P; Trahair, T; Casey, J; Mapp, S; Cheung, C; Armytage, T; Henderson, M; Sutton, R; Rehn, J; Page, E; Heatley, S; Button, P; Rowley, L; Larsen, SR; Presgrave, P; Kwan, J; Bennett, S; Fong, CY; Dalla Pozza, L; Yeung, D; White, D; Australasian Leukaemia and Lymphoma Group;
Details: Publication Year 2026-01,Volume 10,Issue #1,Page e70291
Journal Title: Hemasphere
Publication Type: Research article
Abstract: Pediatric regimens improve outcomes in adolescent and young adult (AYA) acute lymphoblastic leukemia (ALL) patients. End-consolidation (time point 2 [TP2]) minimal residual disease negativity (MRD(neg)) is associated with improved survival. In this study, standard consolidation chemotherapy was replaced with blinatumomab to improve TP2 MRD(neg)-a key survival surrogate in B-lineage ALL. From 2019 to 2022, 55 patients constituted the intention-to-treat (ITT) cohort, median age 25 (range, 16-39) years. Using a Simon's 2-stage design, blinatumomab replaced standard consolidation chemotherapy cycles with TP2 MRD(neg) as the primary endpoint. Blinatumomab was associated with an improved TP2 MRD(neg) rate of 70.8% (95% CI, 55.9%-83.0%) versus the null hypothesis of 60% (P = 0.037). When compared to our previous ALL06 study, median time from protocol I commencement to next treatment phase was 84 versus 97 days (P = 0.0001), with 82.7% versus 45.1% (P < 0.0001), commencing protocol M or high-risk block therapy by day 94. Induction mortality was 1.8%. Blinatumomab was well tolerated. Median follow-up was 42.9 (range, 1.9-54.7) months, with 3-year disease-free survival (DFS) 88.6% (95% CI, 76.3%-94.7%) and 3-year overall survival (OS) 90.5% (95% CI, 78.6%-95.9%) in the ITT cohort. Higher than medium-risk patients had poorer DFS but not OS. Standard genomic risk patients had 100% 3-year DFS and OS. Adverse genomic risk stratified by TP2 MRD(pos) predicted poorer DFS but not OS. Blinatumomab consolidation for de novo B-lineage AYA ALL was associated with high MRD(neg) rates and excellent survival, particularly in standard-risk disease. Genomics may assist in predicting response to blinatumomab in de novo ALL (ACTRN12618001734257).
Publisher: Wiley
Department(s): Haematology
Publisher's Version: https://doi.org/10.1002/hem3.70291
Open Access at Publisher's Site: https://doi.org/10.1002/hem3.70291
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2026-01-29 05:40:52

Last Modified: 2026-01-29 05:40:57