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Abstract
Minimal residual disease (MRD) is the strongest predictor of relapse in B-cell precursor acute lymphoblastic leukemia (BCP-ALL). In BLAST study (NCT01207388), adults with BCP-ALL in remission with MRD after chemotherapy received blinatumomab, a CD19 BiTE® immuno-oncotherapy, 15 µg/m2/day for up to four 6-week cycles (4 weeks continuous infusion, 2 weeks off). Survival was evaluated for 110 patients, including 74 who received HSCT in continuous complete remission. With a median follow-up of 59·8 months, median survival (months) was 36·5 (95% CI: 22.0–not reached [NR]). Median survival was NR (29.5–NR) for complete MRD responders (n = 84) and 14.4 (3.8–32.3) for MRD non-responders (n = 23; p = 0.002); after blinatumomab and HSCT, median survival was NR (25.7–NR) (n = 61) and 16.5 (1.1–NR) (n = 10; p = 0.065), respectively. This final analysis suggests complete MRD response during blinatumomab treatment is curative. Post-hoc analysis of study data suggests while post blinatumomab HSCT may be beneficial in appropriate patients, long-term survival without HSCT is also possible.
Author contributions
G.Z. and N.M. contributed to the concept and design of the study; N.G., H.D., M.Bo., C.G., C.F., M.Br., A.R., H-A.H., V.H., M.S.T., and R.C.B. collected patient data; all authors contributed to the analysis and interpretation of data; all authors contributed to the writing of the paper.
Disclosure statement
N.G. serves on an advisory board and speakers’ bureau for and reports research support associated with the present work and travel support from Amgen; and serves on an advisory board and speakers’ bureau for and reports travel support from Pfizer. G.Z. is an employee and stockholder of and reports patent royalties from Amgen. H.D. is an advisor for, serves on a speakers’ bureau for and reports research support, consultancy, honoraria and travel/accommodation support from Amgen; is an advisor for and reports research support and honoraria from Roche/Genentech; is an advisor for, serves on a speakers’ bureau for and reports honoraria and travel/accommodation support from Pfizer; is an advisor for, serves on a speakers’ bureau for and reports research support, honoraria and travel/accommodation support from Ariad (Incyte); is an advisor for and reports research support and honoraria from Jazz Pharma and Kite Pharma; is an advisor for and reports honoraria from Novartis, Agios, Sunesis, Ambit (Daiichi Sankyo), Karyopharm, Menarini, Astellas, Janssen, Servier, Seattle Genetics and Cellectis; and is a consultant and advisor for, serves on a speakers’ bureau for and reports honoraria from Celgene. A.S. reports lecture fees from Amgen. M.Bo. reports consulting fees from Amgen, Pfizer, Bristol-Myers Squibb and Ariad Pharmaceuticals (Incyte); and research funding from Novartis. C.G. reports consulting fees from Amgen. C.F. serves on an advisory board for and reports research support associated with the present work from Amgen. M.Br. reports consulting fees from Amgen, Incyte and Roche; and research funding from Affimed and Regeneron. K.T. and N.M. are employees and stockholders of Amgen. H-A.H. reports research funding and travel support from Amgen, serves on advisory boards for Amgen, Pfizer, Jazz Pharmaceuticals, and Novartis, reports research funding from Regeneron. M.S.T. serves on an advisory board for and reports travel support from Amgen; reports travel support from Roche; serves on an advisory board for and reports travel support from Affimed and Regeneron; and serves on an advisory board for Gilead and Jazz Pharma. R.C.B. is an advisor for Amgen, Novartis, AstraZeneca, Genmab, GEMoaB, Cellex and Pfizer; and reports patent royalties from Amgen. A.R. and V.H. have no conflict of interest to disclose.