• Mark R Litzow, Zhuoxin Sun, Ryan J Mattison, Elisabeth M Paietta, Kathryn G Roberts, Yanming Zhang, Janis Racevskis, Hillard M Lazarus, Jacob M Rowe, Daniel A Arber, Matthew J Wieduwilt, Michaela Liedtke, Julie Bergeron, Brent L Wood, Yaqi Zhao, Gang Wu, Ti-Cheng Chang, Wenchao Zhang, Keith W Pratz, Shira N Dinner, Noelle Frey, Steven D Gore, Bhavana Bhatnagar, Ehab L Atallah, Geoffrey L Uy, Deepa Jeyakumar, Tara L Lin, Cheryl L Willman, Daniel J DeAngelo, Shejal B Patel, Michelle A Elliott, Anjali S Advani, Dimitrios Tzachanis, Pankit Vachhani, Rupali R Bhave, Elad Sharon, Richard F Little, Harry P Erba, Richard M Stone, Selina M Luger, Charles G Mullighan, and Martin S Tallman.
• From the Mayo Clinic, Rochester, MN (M.R.L., C.L.W., M.A.E.); Dana-Farber Cancer Institute, Boston (Z.S., D.J.D., R.M.S.); the University of Wisconsin Carbone Cancer Center, Madison (R.J.M.), and the Medical College of Wisconsin, Milwaukee (E.L.A.); Montefiore Medical Center Moses Campus (E.M.P., J.R.) and Memorial Sloan Kettering Cancer Center (Y. Zhang, M.S.T.) - both in New York; the Department of Pathology and the Center for Excellence for Leukemia Studies (K.G.R., Y. Zhao, C.G.M.) and the Center for Applied Bioinformatics (G.W., T.-C.C., W.Z.), St. Jude's Children's Research Hospital, Memphis, TN; Case Western Reserve University (H.M.L.) and Cleveland Clinic Foundation (A.S.A.), Cleveland, and the Ohio State University Comprehensive Cancer Center, Columbus (B.B.) - all in Ohio; Shaare Zedek Medical Center, Jerusalem, Israel (J.M.R.); Stanford Cancer Institute, Palo Alto (D.A.A., M.L.), the University of California, San Diego, Moores Cancer Center, La Jolla (M.J.W., D.T.), and the University of California, Irvine, Health Cancer Center-Newport, Orange (D.J.) - all in California; the University of Chicago (D.A.A.) and Northwestern University (S.N.D.) - both in Chicago; Hopital Maisonneuve-Rosemont, Montreal (J.B.); the University of Washington, Seattle (B.L.W.); Johns Hopkins University Sidney Kimmel Cancer Center, Baltimore (K.W.P.), and the National Cancer Institute, National Institutes of Health, Bethesda (E.S., R.F.L.) - both in Maryland; the University of Pennsylvania Abramson Cancer Center, Philadelphia (N.F., S.M.L.); Yale School of Medicine, New Haven, CT (S.D.G.); the Washington University in St. Louis School of Medicine, St. Louis (G.L.U.); the University of Kansas Cancer Center, Westwood (T.L.L.); Virginia Commonwealth University Massey Cancer Center, Richmond (S.B.P.); the University of Alabama at Birmingham, Birmingham (P.V.); and Wake Forest University Health Sciences, Winston-Salem (R.R.B.), and Duke University Medical Center, Durham (H.P.E.) - both in North Carolina.
• N. Engl. J. Med. 2024 Jul 25; 391 (4): 320333320-333.

BackgroundMany older adults with B-cell precursor acute lymphoblastic leukemia (BCP-ALL) have a relapse despite having a measurable residual disease (MRD)-negative complete remission with combination chemotherapy. The addition of blinatumomab, a bispecific T-cell engager molecule that is approved for the treatment of relapsed, refractory, and MRD-positive BCP-ALL, may have efficacy in patients with MRD-negative remission.MethodsIn a phase 3 trial, we randomly assigned patients 30 to 70 years of age with BCR::ABL1-negative BCP-ALL (with :: indicating fusion) who had MRD-negative remission (defined as <0.01% leukemic cells in bone marrow as assessed on flow cytometry) after induction and intensification chemotherapy to receive four cycles of blinatumomab in addition to four cycles of consolidation chemotherapy or to receive four cycles of consolidation chemotherapy alone. The primary end point was overall survival, and relapse-free survival was a secondary end point.ResultsThe data and safety monitoring committee reviewed the results from the third efficacy interim analysis and recommended that they be reported. Complete remission with or without full count recovery was observed in 395 of 488 enrolled patients (81%). Of the 224 patients with MRD-negative status, 112 were assigned to each group. The characteristics of the patients were balanced between the groups. At a median follow-up of 43 months, an advantage was observed in the blinatumomab group as compared with the chemotherapy-only group with regard to overall survival (at 3 years: 85% vs. 68%; hazard ratio for death, 0.41; 95% confidence interval [CI], 0.23 to 0.73; P = 0.002), and the 3-year relapse-free survival was 80% with blinatumomab and 64% with chemotherapy alone (hazard ratio for relapse or death, 0.53; 95% CI, 0.32 to 0.87). A higher incidence of neuropsychiatric events was reported in the blinatumomab group than in the chemotherapy-only group.ConclusionsThe addition of blinatumomab to consolidation chemotherapy in adult patients in MRD-negative remission from BCP-ALL significantly improved overall survival. (Funded by the National Institutes of Health and others; E1910 ClinicalTrials.gov number, NCT02003222.).Copyright © 2024 Massachusetts Medical Society.

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