blinatumomab subcutaneous / Amgen, BeOne Medicines - LARVOL DELTA

SUBCUTANEOUS BLINATUMOMAB FOR PATIENTS WITH RELAPSED/REFRACTORY PHILADELPHIA CHROMOSOME–POSITIVE B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA: RESULTS FROM A PHASE 1/2 STUDY (EHA 2026) - P1/2 | "Eight patients (50%) received a TKI concurrently with SC blinatumomab (250/500: ponatinib, n=4; dasatinib, n=1; imatinib, n=1; 500/1000: ponatinib, n=2) with no new safety signals observed. These data support further evaluation of SC blinatumomab across Ph+ B-ALL settings. B-ALL, B-cell acute lymphoblastic leukemia; CR, complete remission; CRh, complete remission with partial hematologic recovery; CRi, complete remission with incomplete hematologic recovery; HSCT, hematopoietic stem cell transplantation; IP, investigational product; Ph+, Philadelphia chromosome–positive; R/R, relapsed or refractory; SC, subcutaneous; TIW, thrice weekly; TKI, tyrosine kinase inhibitor; QD, once daily"

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

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: Aug 2033 ➔ Aug 2035 | Initiation date: Jun 2026 ➔ Jun 2028 | Trial primary completion date: May 2030 ➔ Dec 2031

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

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

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

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

A Phase 1b/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) - P1/2 | N=3 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Phase classification: P2 ➔ P1/2

Phase classification • 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 | Initiation date: Jul 2026 ➔ Jan 2027

Trial initiation date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • BCR

A Study of Inotuzumab and Blinatumomab in People With B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1/2 | N=26 | Not yet recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Initiation date: Jun 2026 ➔ Sep 2026

Trial initiation date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • BCR • CD22

Second Quarter Product and Pipeline Update (PRNewswire) - "A potentially registration-enabling Phase 2 study of subcutaneous blinatumomab in both adults and adolescents with relapsed or refractory CD19-positive Philadelphia chromosome (Ph) negative B-ALL has paused enrollment of new patients following a partial clinical hold by the FDA; A Phase 1b/2 study of subcutaneous blinatumomab in pediatric patients with relapsed or refractory and minimal residual disease positive (MRD+) B-ALL has paused enrollment of new patients following a partial clinical hold by the FDA; Discussions are underway with the FDA on a path forward to reopen both subcutaneous blinatumomab studies."

Trial status • B Acute Lymphoblastic Leukemia

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 | Initiation date: May 2026 ➔ Nov 2026

Trial initiation date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • KMT2A

FIRST-IN-WORLD SUBCUTANEOUS BLINATUMOMAB FOR CD19-POSITIVE MIXED PHENOTYPE ACUTE LEUKEMIA (MPAL): MULTICENTER PHASE II TRIAL AND FIRST PATIENT COMPLETE REMISSION WITH MINIMAL RESIDUAL DISEASE NEGATIVE (EHA 2026) - P2 | "She received steroid cytoreduction then initiated SC-blin per protocol with concomitant dasatinib (100 mg orally daily). Summary/Conclusion This first patient achieved an unprecedented MRD-negative CR after a single cycle of SC-blin in CD19 + MPAL, demonstrating potent activity with predominantly out-pt delivery. Accrual is ongoing across newly diagnosed elderly/unfit, MRD-positive, and R/R cohorts."

Clinical • Minimal residual disease • P2 data • Residual disease • Hematological Malignancies • Leukemia • ABL1 • BCR • CD34 • CD79A • MPO • PAX5

A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL (clinicaltrials.gov) - P1/2 | N=181 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting | N=281 ➔ 181

Enrollment change • Enrollment closed • Minimal residual disease • 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=3 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Recruiting ➔ Active, not recruiting | N=60 ➔ 3

Enrollment change • Enrollment closed • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

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

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

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 | Active, not recruiting | Sponsor: Amgen | Recruiting ➔ Active, not recruiting

Enrollment closed • Minimal residual disease • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • CD19

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

Minimal residual disease • Trial initiation date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • CD19

Subcutaneous Blinatumomab Plus Ponatinib for BCR-ABL+ B-ALL (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: University of Alberta | Initiation date: Mar 2026 ➔ Jul 2026

Trial initiation date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • BCR

Parent-Perceived Difficulties Associated With Injections During Acute Lymphoblastic Leukemia Therapy (ASPHO 2026) - "Many children receive both chemotherapy agents, such as cytarabine and asparaginase, and supportive care medications, such as enoxaparin, by injection...Survey items assessed experiences with blinatumomab, IM and subcutaneous injections, and perceptions of potential subcutaneous blinatumomab delivery... IM and subcutaneous medication administration contribute significant emotional and logistical burden for children with ALL and their families. As current and emerging therapies increasingly rely on injectable administration, there is an urgent need to investigate and implement family supports and interventions to optimize the treatment experience and reduce therapy related distress."

Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Mood Disorders • T Acute Lymphoblastic Leukemia

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

Minimal residual disease • Trial initiation date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • CD19

A Study of Inotuzumab and Blinatumomab in People With B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1/2 | N=26 | Not yet recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Phase classification: P2 ➔ P1/2 | Initiation date: Mar 2026 ➔ Jun 2026

Phase classification • Trial initiation date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • BCR • CD22

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 | Initiation date: Feb 2026 ➔ Sep 2026

Trial initiation date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • 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