blinatumomab subcutaneous / Amgen, BeOne Medicines - LARVOL DELTA

Subcutaneous blinatumomab in adults with relapsed or refractory B-cell acute lymphoblastic leukaemia: post-hoc safety and activity analysis from a multicentre, single-arm, phase 1/2 trial. (PubMed, Lancet Haematol) - P1/2 | "Treatment with subcutaneous blinatumomab at the two dose regimens of 250 μg/500 μg and 500 μg/1000 μg resulted in promising preliminary activity and a manageable safety profile in adults with relapsed or refractory B-cell acute lymphoblastic leukaemia. The phase 2 part of the trial is ongoing to further evaluate subcutaneous blinatumomab activity and duration of response."

Journal • P1/2 data • Retrospective data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Disorders • Hematological Malignancies • Inflammation • Leukemia • Neutropenia • Oncology

A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases (clinicaltrials.gov) - P2 | N=220 | Recruiting | Sponsor: Amgen | N=98 ➔ 220 | Trial completion date: Jun 2029 ➔ Mar 2029 | Trial primary completion date: Sep 2028 ➔ Jan 2028

Enrollment change • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus • CRP

A Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Combination With Low Intensity Chemotherapy in Older Patients With Newly Diagnosed B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

20220107: A phase 1/2 study of subcutaneous blinatumomab administration in children with R/R and MRD+ B-ALL (clinicaltrialsregister.eu) - P1/2 | N=6 | Not yet recruiting | Sponsor: Amgen Inc.

Minimal residual disease • New P1/2 trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • CD19

Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients With Philadelphia Chromosome (ph)-Positive and/or BCR::ABL1 Positive Acute Lymphoblastic Leukemia (ALL) (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Sep 2031 ➔ Sep 2033 | Initiation date: Feb 2026 ➔ Aug 2026 | Trial primary completion date: Sep 2026 ➔ Sep 2031

Trial completion date • Trial initiation date • Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1

AUDAX: A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Lymphoblastic Leukaemia (clinicaltrials.gov) - P3 | N=560 | Not yet recruiting | Sponsor: Amgen | Trial completion date: Mar 2033 ➔ Aug 2033 | Initiation date: Jan 2026 ➔ Jun 2026 | Trial primary completion date: Dec 2029 ➔ May 2030

Trial completion date • Trial initiation date • Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

First-in-World Subcutaneous Blincyto Trial Opens for Leukemia at WVU (Cure Today) - "The investigator-initiated trial is the first to examine a subcutaneous formulation of the CD19-directed bispecific T-cell engager in this ultra-rare and aggressive leukemia, a disease with no established standard of care and historically poor outcomes."

Trial status • Central Nervous System Leukemia • Leukemia

COMPARATIVE EFFICACY OF THE GIMEMA LAL1913 STANDARD CHEMOTHERAPY PROTOCOL VERSUS THE STANDARD ARM OF THE E1910 TRIAL IN MRD-NEGATIVE PH-NEGATIVE ALL: A MAIC ANALYSIS (EHA 2025) - "In the E1910 trial (Litzow et al, NEJM 2024), Ph- B-ALL patients MRD- after induction treatment were randomized to receive as consolidation standard of care chemotherapy (SOC) or SOC plus blinatumomab. The GIMEMA LAL1913 chemotherapy regimen offers outcomes comparable to those of the E1910 trial's standard arm in MRD- Ph- B-ALL, supporting the clinical equivalence of the Italian standard approach. These findings also provide indirect evidence of the superiority of blinatumomab and to advocate for the adoption of blinatumomab-based consolidation, to further improve outcomes also in MRD- Ph- B-ALL patients."

Clinical • Minimal residual disease • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Thrombocytopenia

SAFETY AND EFFICACY OF SINGLE-AGENT SUBCUTANEOUS BLINATUMOMAB IN ADULTS WITH RELAPSED/REFRACTORY (R/R) B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL): RESULTS FROM A PHASE 1/2 DOSE EXPANSION STUDY (EHA 2025) - P1/2 | "In this large cohort of 88 pts with R/R B-ALL, single agent SC blinatumomab, resulted in high efficacy, with high MRD-negativity rate and acceptable safety profile. The trial is ongoing and will continue to assess efficacy and AE management in phase 2."

Clinical • P1/2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Inflammation • Leukemia • Oncology

Subcutaneous Blinatumomab for Treatment of Adult Patients With CD19-Positive Mixed Phenotype Acute Leukemia (MPAL) (clinicaltrials.gov) - P2 | N=78 | Recruiting | Sponsor: West Virginia University | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Leukemia • Oncology

A Study of Inotuzumab and Blinatumomab in People With Newly Diagnosed B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=26 | Not yet recruiting | Sponsor: Memorial Sloan Kettering Cancer Center

New P2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Subcutaneous Blinatumomab Plus Ponatinib for BCR-ABL+ B-ALL (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: University of Alberta

New P2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1/2 | N=104 | Recruiting | Sponsor: Amgen | Not yet recruiting ➔ Recruiting

Enrollment open • Minimal residual disease • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics

A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL (clinicaltrials.gov) - P1/2 | N=281 | Recruiting | Sponsor: Amgen | Trial primary completion date: Jul 2027 ➔ Nov 2027

Minimal residual disease • Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center

New P1 trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Efficacy of single-agent subcutaneous blinatumomab in adults with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL): Results from a phase 1/2 dose expansion study with extended follow-up (ASH 2025) - P1/2 | "At baseline, patients had received a median of 2 prior lines of therapy (range, 1–7),which included cIV blinatumomab in 17 (22%), chimeric antigen receptor T-cells in 14 (18%), HSCT in 23(29%), and inotuzumab ozogamicin in 26 (33%) patients. Consistent with prior findings, single-agent SC blinatumomab maintained durable remissionsand OS in this extended follow-up analysis. These outcomes were observed across the 250/500 and500/1000 doses and were independent of HSCT status. Compared to our previous report, this analysisincludes additional follow-up and updated post-HSCT outcomes."

Clinical • P1/2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Leukemia • Novel Coronavirus Disease • Septic Shock

Single-Agent Subcutaneous Blinatumomab for Advanced B-Cell Acute Lymphoblastic Leukemia: Long-Term Follow-up from a Phase 1b Dose Expansion Cohort (ASH 2024) - P1/2 | "Of these, 9 pts (33%) were primary refractory, 8 pts (30%) had relapsed after prior HSCT, 4 pts (15%) had relapsed after prior CD19 CAR T–cell therapy, 7 pts (26%) had prior inotuzumab ozogamycin, and 5 pts (19%) had previously received cIV blinatumomab. The trial continues to accrue. These results warrant further evaluation of SC blinatumomab."

Metastases • P1 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology

A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL (clinicaltrials.gov) - P1/2 | N=281 | Recruiting | Sponsor: Amgen | Trial primary completion date: Dec 2027 ➔ Jul 2027

Minimal residual disease • Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Subcutaneous Blinatumomab for Treatment of Adult Patients With CD19-Positive Mixed Phenotype Acute Leukemia (MPAL) (clinicaltrials.gov) - P2 | N=78 | Not yet recruiting | Sponsor: West Virginia University

New P2 trial • Hematological Malignancies • Leukemia • Oncology

Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Patients With Measurable Residual Disease Positive B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center

New P2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Next Questions: Acute Lymphoblastic Leukemia (SOHO 2025) - "The incorporation of the CD3/CD19 bispecific T-cell engager, blinatumomab, and the anti-CD22 monoclonal antibody-drug conjugate, inotuzumab-ozogamicin, for newly diagnosed Ph-negative B-cell ALL have led to promising survival outcomes in the frontline setting for B-cell ALL...In patients at high risk of CNS relapse — such as those with high baseline white blood cell counts (>70 × 10 9) 3— high-dose cytarabine and methotrexate should be incorporated, especially if allogeneic stem cell transplant (allo-SCT) is not pursued in first complete remission (CR1)...Efforts to improve the outcomes in this subgroup include the hyper-CVAD chemotherapy backbone in combination with nelarabine and pegylated asparaginase, which results in a 3-year OS of around 74%. Furthermore, the addition of venetoclax may improve outcomes, at least in a subset of patients with early T-cell precursor (ETP) ALL...14–17 Conclusions The future of ALL treatment includes the continued optimization..."

IO biomarker • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD5 • CD7 • KMT2A

Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients With Philadelphia Chromosome (ph)-Positive and/or BCR::ABL1 Positive Acute Lymphoblastic Leukemia (ALL) (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center

New P2 trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

A Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Combination With Low Intensity Chemotherapy in Older Patients With Newly Diagnosed B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center

New P2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL (clinicaltrials.gov) - P1/2 | N=281 | Recruiting | Sponsor: Amgen | Active, not recruiting ➔ Recruiting

Enrollment open • Minimal residual disease • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1/2 | N=104 | Not yet recruiting | Sponsor: Amgen

Minimal residual disease • New P1/2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics