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The E1910 trial results showed improved OS and RFS with blinatumomab vs chemotherapy in patients with newly diagnosed BCR::ABL1-negative B ALL.
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Relapse-free and overall survival (OS) were improved in patients with minimal residual disease (MRD) status aged 30 to 54 years who were newly diagnosed with BCR::ABL1-negative B acute lymphoblastic leukemia (ALL) and given consolidation blinatumomab (Blincyto) and chemotherapy in combination vs chemotherapy alone, according to results from the phase 3 E1910 trial (NCT02003222) presented at the European Hematology Association 2025 Congress.
The 3-year relapse-free survival (RFS) rate for this patient population in the blinatumomab arm was 86% vs 66% in the chemotherapy arm (HR, 0.37; 95% CI, 0.17-0.81). For patients who were aged 30 to 39 and were MRD negative, the 3-year OS rates were 100% vs 73% (P = .009), and the RFS rates were 90% vs 69% (P = .03).
For patients who were MRD negative with BCR::ABL1-like disease, the 3-year OS and RFS rates were similar in both arms at 100% vs 45% (P = .02), respectively. Of note, 37% of patients underwent hematopoietic cell transplant.
The correlation between body mass index (BMI) and the survival end points were assessed with blinatumomab plus chemotherapy. For a BMI of less than 30 kg/m2, the 3-year OS rate was 94% with the combination and the RFS rate was 86%. For those with a BMI of 30 kg/m2 or greater, the 3-year OS rate was 90% and the RFS rate was 87%.
“These results and the pediatric COG AALL 1731 data suggest that blinatumomab should be incorporated into the care of all adolescents and young adults with B ALL,” Shira N. Dinner, MD, associate professor in the Feinberg School of Medicine at Northwestern Medicine, in Chicago, Illinois said during the presentation.
In E1910, patients aged between 30 and 70 years old with newly diagnosed, BCR::ABL1-negative B ALL and were in MRD-negative complete response (CR) following intensification received 4 cycles of consolidation chemotherapy with or without 4 blinatumomab cycles.
After randomization to the experimental arm, blinatumomab was given for 2 cycles, with an MRD assessment. Patients received either an allogeneic bone marrow transplant followed by an MRD assessment or consolidation for 6 cycles followed by an MRD assessment.
Patients were stratified by age (≥55 years vs <55 years), CD20 status, rituximab (Rituxan) use, and hematopoietic stem cell transplant intent. A total of 488 patients were randomly assigned 1:1.
Furthermore, 277 patients who were 55 years old or younger were included in this part of the trial. The median age was 42 years, 37% were between 30 and 39 years, 48% were female, and 78% were White. For molecular risk group, patients were classified as having either favorable (18%), intermediate (16%), or unfavorable disease (52%), or not assigned (13%).
The CR/CR with incomplete hematologic recovery rate was 86%. Two percent 2% of patients died due to respiratory failure, neutropenic fever, multiorgan failure, hepatic failure, or hypotension. Twenty-nine percent of patients did not reach the randomization step in the overall trial because of either death, recurrent disease, adverse effects (AEs), or study withdrawal.
Regarding E1910 patients’ status, molecular risk included favorable (21% vs 33%), intermediate (26% vs 18%), unfavorable (30% vs 35%), or not assigned (23% vs 14%) between the blinatumomab and chemotherapy arms, respectively. The number of blinatumomab cycles completed included 9% for cycle 1, 27% for cycle 2, 3% for cycle 3, and 61% for cycle 4. Additionally, 45% of patients completed the maintenance protocol, 11 patients in the blinatumomab arm and 11 in the chemotherapy arm received HSCT on study vs 5 and 8, respectively, receiving HSCT off-study.
In the consolidation phase, grade 3/4 TRAEs in the blinatumomab and chemotherapy arms included neutrophil count decrease (80% vs 89%, respectively), neutropenic fever (20% vs 26%), infection (20% vs 12%), platelet count decrease (59% vs 70%), neurologic disorders (38% vs 11%), and anemia (31% vs 37%).
In the maintenance phase, grade 3/4 TRAEs included decreased neutrophil count (60% vs 55%), decreased platelet count (28% vs 26%), increased alanine aminotransferase/serum glutamic-pyruvic transaminase (20% vs 31%), and anemia (14% vs 10%).
One patient on the blinatumomab arm had grade 5 intracranial hemorrhage during consolidation, and another had grade 5 cardiac arrest during the maintenance portion of the study.
“Further studies should evaluate the potential to increase MRD negativity and decrease the use of chemotherapy and HCT,” Dinner concluded.
Reference
Dinner SN, Sun Z, Paietta EM, et al. Addition of blinatumomab to consolidation therapy for younger adults (< 55 years) with newly diagnosed BCR::ABL1-negative B-acute lymphoblastic leukemia (ALL) on the ECOG-ACRINE E1910 phase III trial. Presented at: European Hematology Association 2025 Congress; June 12-15, 2025; Milan, Italy. Abstract S110.
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