Blinatumomab for MRD-Negative Acute Lymphoblastic Leukemia in Adults.
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Litzow Mark R, Sun Zhuoxin, Mattison Ryan J, Paietta Elisabeth M, Roberts Kathryn G, Zhang Yanming, Racevskis Janis, Lazarus Hillard M, Rowe Jacob M, Arber Daniel A, Wieduwilt Matthew J, Liedtke Michaela, Bergeron Julie, Wood Brent L, Zhao Yaqi, Wu Gang, Chang Ti-Cheng, Zhang Wenchao, Pratz Keith W, Dinner Shira N, Frey Noelle, Gore Steven D, Bhatnagar Bhavana, Atallah Ehab L, Uy Geoffrey L, Jeyakumar Deepa, Lin Tara L, Willman Cheryl L, DeAngelo Daniel J, Patel Shejal B, Elliott Michelle A, Advani Anjali S, Tzachanis Dimitrios, Vachhani Pankit, Bhave Rupali R, Sharon Elad, Little Richard F, Erba Harry P, Stone Richard M, Luger Selina M, Mullighan Charles G, Tallman Martin S
Аннотация
METHODS: In 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.
RESULTS: The 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.
CONCLUSIONS: The 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.).