RegulationPriority Review (US), Accelerated Approval (US), Orphan Drug (EU), Priority Review (CN), Conditional marketing approval (CN), Orphan Drug (KR), Orphan Drug (GB), Breakthrough Therapy (US), Orphan Drug (US)

Gene Sequence

Sequence Code 112821

Source: *****

134

Clinical Trials associated with Blinatumomab

NCT06124157 / Not yet recruitingPhase 3IIT

A Randomized International Phase 3 Trial of Imatinib and Chemotherapy With or Without Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or Philadelphia Chromosome-Like ABL-Class B-Cell Acute Lymphoblastic Leukemia

This phase III trial compares the effect of the combination of blinatumomab with dasatinib and standard chemotherapy versus dasatinib and standard chemotherapy for treating patients with Philadelphia chromosome positive (PH+) or Philadelphia chromosome-like (Ph-Like) ABL-class B-Cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is a bispecific antibody that binds to two different proteins-one on the surface of cancer cells and one on the surface of cells in the immune system. An antibody is a protein made by the immune system to help fight infections and other harmful processes/cells/molecules. Blinatumomab may bind to the cancer cell and a T cell (which plays a key role in the immune system's fighting response) at the same time. Blinatumomab may strengthen the immune system's ability to fight cancer cells by activating the body's own immune cells to destroy the tumor. Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving blinatumomab and dasatinib in combination with standard chemotherapy may work better in treating patients with PH+ or Ph-Like ABL-class B-ALL compared to dasatinib and chemotherapy alone.

Start Date28 Feb 2025

Sponsor / Collaborator

National Cancer Institute

NCT06317662 / Not yet recruitingPhase 2IIT

A Phase 2 Study of Blinatumomab in Combination With Chemotherapy for Infants With Newly Diagnosed Acute Lymphoblastic Leukemia With Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax

This phase II trial tests the addition of venetoclax and/or blinatumomab to usual chemotherapy for treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) with a KMT2A gene rearrangement (KMT2A-rearranged [R]) or without a KMT2A gene rearrangement (KMT2A-germline [G]). Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding venetoclax and/or blinatumomab to standard chemotherapy may be more effective at treating patients with ALL than standard chemotherapy alone, but it may also cause more side effects. This clinical trial evaluates the safety and effectiveness of adding venetoclax and/or blinatumomab to chemotherapy for the treatment of infants with KMT2A-R or KMT2A-G ALL.

Start Date26 Jan 2025

Sponsor / Collaborator

National Cancer Institute

NCT06570798 / Not yet recruitingPhase 2

A Phase 2a, Open Label, Multi Center, Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Autoimmune Diseases

The main objective is to assess the safety and tolerability of inebilizumab (Subprotocol A) and subcutaneous (SC) blinatumomab (Subprotocol B) in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis.

Start Date31 Dec 2024

Sponsor / Collaborator

Amgen, Inc.

100 Clinical Results associated with Blinatumomab

100 Translational Medicine associated with Blinatumomab

100 Patents (Medical) associated with Blinatumomab

916

Literatures (Medical) associated with Blinatumomab

31 Dec 2024·Hematology (Amsterdam, Netherlands)

A review of immunotargeted therapy for Philadelphia chromosome positive acute lymphoblastic leukaemia: making progress in chemotherapy-free regimens

Review

Author: Zhang, Shi-Zhong ; Xiong, Zhen-Yu ; Zhu, Hong-Hu ; Shen, Yao-Jia

Philadelphia chromosome-positive acute lymphoblastic leukemia (PH + ALL) is the most common cytogenetic abnormality of B-ALL in adults and is associated with poor prognosis. Previously, the only curative treatment option in PH + ALL was allogeneic hematopoietic stem cell transplantation (Allo-HSCT). Since 2000, targeted therapy combined with chemotherapy, represented by the tyrosine kinase inhibitor Imatinib, has become the first-line treatment for PH + ALL. Currently, the remission rate and survival rate of Imatinib are superior to those of simple chemotherapy, and it can also improve the efficacy of transplantation. More recently, some innovative immune-targeted therapy greatly improved the prognosis of PH + ALL, such as Blinatumomab and Inotuzumab Ozogamicin. For patients with ABL1 mutations and those who have relapsed or are refractory to other treatments, targeted oral small molecule drugs, monoclonal antibodies, Bispecific T cell Engagers (BiTE), and chimeric antigen receptor (CAR) T cells immunotherapy are emerging as potential treatment options. These new therapeutic interventions are changing the treatment landscape for PH + ALL. In summary, this review discusses the current advancements in targeted therapeutic agents shift in the treatment strategy of PH + ALL towards using more tolerable chemotherapy-free induction and consolidation regimens confers better disease outcomes and might obviate the need for HSCT.

31 Dec 2024·mAbs

A pivotal decade for bispecific antibodies?

Article

Author: Surowka, Marlena ; Klein, Christian

Bispecific antibodies (bsAbs) are a class of antibodies that can mediate novel mechanisms of action compared to monospecific monoclonal antibodies (mAbs). Since the discovery of mAbs and their adoption as therapeutic agents in the 1980s and 1990s, the development of bsAbs has held substantial appeal. Nevertheless, only three bsAbs (catumaxomab, blinatumomab, emicizumab) were approved through the end of 2020. However, since then, 11 bsAbs received regulatory agency approvals, of which nine (amivantamab, tebentafusp, mosunetuzumab, cadonilimab, teclistamab, glofitamab, epcoritamab, talquetamab, elranatamab) were approved for the treatment of cancer and two (faricimab, ozoralizumab) in non-oncology indications. Notably, of the 13 currently approved bsAbs, two, emicizumab and faricimab, have achieved blockbuster status, showing the promise of this novel class of therapeutics. In the 2020s, the approval of additional bsAbs can be expected in hematological malignancies, solid tumors and non-oncology indications, establishing bsAbs as essential part of the therapeutic armamentarium.

31 Dec 2024·Hematology

Successful treatment of two cases with Philadelphia-chromosome positive acute lymphoblastic leukemia who relapsed after allogeneic stem cell transplantation and the treatments with novel immunotherapies and ponatinib

Article

Author: Noguchi, Yuma ; Tanaka, Masatsugu ; Sadato, Daichi ; Doki, Noriko ; Harada, Yuka ; Nakajima, Hideaki ; Tamai, Yotaro ; Najima, Yuho ; Tachibana, Takayoshi

The outcomes of relapsed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) resistant to new drugs such as tyrosine kinase inhibitors, inotuzumab ozogamicin (InO) and blinatumomab are dismal. We treated two cases of Ph+ALL resistant to these drugs that achieved long-term survival after treatment with chimeric antigen receptor (CAR)-T cell therapy or a second allogeneic hematopoietic stem cell transplantation (HCT) with a sequential conditioning regimen. Case 1: A 15-year-old boy was diagnosed with Ph+ALL. Despite the second HCT after the treatment of ponatinib and blinatumomab, hematological relapse occurred. InO was ineffective and he was transferred to a CAR-T center. After the CAR-T cell therapy, negative measurable residual disease (MRD) was achieved and maintained for 38 months without maintenance therapy. Case 2: A 21-year-old man was diagnosed with Ph+ALL. Hematological relapse occurred after the first HCT. Despite of the treatment with InO, ponatinib, and blinatumomab, hematological remission was not achieved. The second HCT was performed using a sequential conditioning regimen with clofarabine. Negative MRD was subsequently achieved and maintained for 42 months without maintenance therapy. These strategies are suggestive and helpful to treat Ph+ALL resistant to multiple immunotherapies.

125

News (Medical) associated with Blinatumomab

08 Dec 2024

·endpts.com

AstraZeneca reveals first clinical data for bispecific T cell engager from TeneoTwo buyout

SAN DIEGO — AstraZeneca is getting ready to step on the gas in the world of bispecific T cell engagers. The company presented some of its first Phase 1 data for its CD3xCD19 bispecific known as AZD0486 — which is being tested in multiple B cell malignancies — at the American Society of Hematology’s annual meeting this weekend. Data come from a larger study where AstraZeneca is testing the program against a broad range of blood cancers, where the company tested four dose levels. Researchers touted results in later-line follicular lymphoma and diffuse large B cell lymphoma (DLBCL). In 27 patients with follicular lymphoma who received any of the three highest doses, AZD0486 induced a 96% objective response rate and an 85% complete response rate, AstraZeneca said. Additionally, in the two middle dose levels, 17 of 19 patients achieved undetectable minimal residual disease — an endpoint where the FDA is proving increasingly receptive toward in other blood cancers — by 12 weeks. In DLBCL, a much harder disease to treat, the responses were less potent, according to last month’s abstract. At the dose expected to move into further studies, nine of 19 patients (47%) responded, with eight of 19 (42%) reaching a complete response. AstraZeneca is expected to break down additional DLBCL results in a presentation Monday evening Pacific time. But most promising about these data is how even patients who had previously taken CAR-T or anti-CD20 therapies were seeing responses, AstraZeneca’s executive VP for oncology R&D Susan Galbraith told Endpoints News . Among 14 individuals who progressed after CAR-T in the study at the target dose level, the ORR was 36% and the complete response rate was 29%. Patients whose cancers progress after taking CAR-T, in particular, have extremely limited treatment options, Galbraith said, but bispecifics as a whole appear to be emerging as a new alternative. “I think that bodes well, not just for an option for those patients, but also the potential for those to be really quite efficacious in the early lines of treatments as well,” she said. “We’ve got work to do to deliver all of that data, but so far, I’m quite excited about potential for this market.” AZD0486 came to AstraZeneca in its buyout of TeneoTwo, acquired in 2022 for up to $1.27 billion, including milestones (AstraZeneca paid only $100 million upfront). TeneoTwo is itself an offshoot from Teneobio, which spun it off after being bought by Amgen in 2021 for $900 million upfront and another $1.6 billion in milestones. The only other approved CD3xCD19 bispecific is Amgen’s Blincyto, which was first approved in 2014. Blincyto has since racked up half a dozen other approvals, but they’ve all come in different settings for acute lymphoblastic leukemia (ALL). In 2023, Amgen reported $861 million in worldwide Blincyto sales. Galbraith said the lack of other such drugs has given AstraZeneca the right opportunity to design their compound in a way where it can best take advantage of the market. There is still the potential for combination therapies, particularly for the DLBCL setting, that have yet to be explored in the clinic. Other companies have taken note recently, with a slew of CD19 bispecific deals announced in recent months. In August, Merck paid $700 million upfront for Curon Biopharmaceutical’s CD3xCD19 compound, and GSK spent $300 million upfront in October for a bispecific from Chimagen Biosciences to test it in autoimmune disease. But Galbraith also believes AZD0486 can be more efficacious, too. “I don’t think you get to the same level of exposure with [Blincyto] as we can achieve with this,” Galbraith said. “And it’s early days yet. But I’m encouraged by the profile that we’re seeing and the potential to have a better CD19 bispecific option for patients in ALL.”

Clinical ResultDrug ApprovalPhase 1AcquisitionImmunotherapy

07 Dec 2024

·www.globenewswire.com

Adaptive Biotechnologies Announces New Data at the 66th ASH Annual Meeting Highlighting Advances in MRD Testing with clonoSEQ® and Its Impact on Blood Cancer Treatment Decisions

New data demonstrate the actionability of clonoSEQ for tailoring treatment decisions in patients with MCL, CLL, MM and ALL Studies show depth of response at 10-6 provides more accurate assessment of treatment responses SEATTLE, Dec. 07, 2024 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced new data demonstrating the impact of measurable residual disease (MRD) assessment using Adaptive’s next-generation sequencing-based clonoSEQ® test in blood cancer clinical care and drug development. The data are featured in more than 65 abstracts being presented at the 66th Annual Meeting of the American Society of Hematology (ASH), taking place December 6-10 in San Diego. “At this year's ASH meeting, we're proud to see clonoSEQ's pivotal role in shaping the future of blood cancer care,” said Susan Bobulsky, chief commercial officer, MRD, Adaptive Biotechnologies. “The breadth of data presented highlight the growing recognition of clonoSEQ as a powerful tool for accelerating patient access to novel therapies, optimizing clinical care and delivering actionable insights that improve outcomes for patients living with a variety of blood cancers." Phase 3 data from the ECOG-ACRIN EA4151 trial indicate that autologous hematopoietic cell transplantation (auto-HCT) may not provide additional benefit for mantle cell lymphoma (MCL) patients in first complete remission (CR) who have undetectable minimal residual disease (uMRD) at a sensitivity of 10⁻⁶. The findings will be presented in a late-breaking abstract titled, Lack of Benefit of Autologous Hematopoietic Cell Transplantation (auto-HCT) in Mantle Cell Lymphoma (MCL) Patients (pts) in First Complete Remission (CR) with Undetectable Minimal Residual Disease (uMRD): Initial Report from the ECOG-ACRIN EA4151 Phase 3 Randomized Trial (Abstract LBA6). Patients in CR with uMRD at 10⁻⁶ sensitivity from peripheral blood were randomized to receive either auto-HCT plus three years of maintenance rituximab (MR) or MR alone. Interim analysis, with a median follow-up of 2.7 years, showed no significant difference in overall survival (OS) between the two groups, suggesting that auto-HCT may be unnecessary for patients achieving deep remission as measured by highly sensitive MRD assessment. “Our study indicates that highly sensitive MRD testing, such as the clonoSEQ assay that we used, can potentially be used to tailor treatment decisions for patients with MCL,” said Timothy Fenske, M.D., professor, department of medicine, Medical College of Wisconsin. “By identifying patients in first complete remission who also have undetectable MRD status at 10⁻⁶, we can potentially avoid the need for autologous hematopoietic cell transplantation, sparing them the associated risks and burdens. At the same time, patients who remain MRD-positive post-induction may benefit from more intensive consolidation therapy such as auto-HCT to optimize their outcomes.” Data from the FELIX study indicate that achieving deep molecular remission, defined as MRD levels below 10⁻⁶, correlates with improved outcomes in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) treated with obecabtagene autoleucel. These findings were presented in an oral session titled Obecabtagene autoleucel (obe-cel) for Adult Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL): Deep Molecular Remission May Predict Better Outcomes (Abstract 963). The study found that 84% of treatment responders who had a clonoSEQ MRD test, achieved MRD <10⁻⁶. This result was associated with more durable responses, and higher event-free survival and OS rates than those observed in patients with MRD ≥10-4 and between 10-4 and 10-6. “Highly sensitive MRD testing provides a more accurate assessment of treatment response, allowing clinicians to make more informed decisions that can lead to improved long-term outcomes,” said Elias Jabbour, M.D., professor of medicine, department of leukemia, The University of Texas MD Anderson Cancer Center. “The findings from the FELIX study underscore the importance of incorporating highly sensitive MRD testing into routine clinical practice to optimize care for patients.” Additional Key clonoSEQ Data Presented at the Meeting: Blinatumomab Added to Chemotherapy Improves Disease-Free Survival in Newly Diagnosed NCI Standard Risk Pediatric B-Acute Lymphoblastic Leukemia: Results from the Randomized Children’s Oncology Group Study AALL1731 (Abstract 1) This Phase 3 randomized trial evaluated the addition of blinatumomab to standard chemotherapy in pediatric patients with newly diagnosed standard-risk (SR) B-ALL with average or higher risk of relapse. In the SR average cohort, patients that were MRD positive by clonoSEQ were randomized to receive standard chemotherapy with or without blinatumomab. The study found that incorporating blinatumomab significantly improved disease-free survival compared to chemotherapy alone, establishing a new treatment standard for this patient population. Implications of MRD Progression in Newly Diagnosed Multiple Myeloma (NDMM) Treated with Quadruplet Therapy and Autologous Stem Cell Transplantation (Abstract 363) This study identified 49 newly diagnosed multiple myeloma (MM) patients treated with a quadruplet regimen followed by autologous stem cell transplantation who experienced MRD progression as assessed by clonoSEQ, or disease progression as defined by the International Myeloma Working Group (IMWG). The median time from MRD progression to IMWG-defined disease progression was 10.1 months, supporting that rising MRD levels are an early indicator of impending clinical relapse in MM patients. Minimal Residual Disease (MRD)-Adapted Duration of Front-Line Venetoclax and Obinutuzumab Treatment for Fit Patients with Chronic Lymphocytic Leukemia (CLL) (Abstract 1010) This Phase 2 study evaluating the use of venetoclax and obinutuzumab in treatment-naïve CLL patients found that those achieving undetectable MRD (<10⁻⁶) after nine cycles could discontinue therapy early. These patients had progression-free survival comparable to those who completed the standard 12 cycles, demonstrating the feasibility of MRD-guided treatment duration to minimize therapy exposure without compromising efficacy. About clonoSEQclonoSEQ is the first and only FDA-cleared in vitro diagnostic (IVD) test to detect minimal residual disease (MRD) in bone marrow from patients with multiple myeloma (MM) or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). clonoSEQ testing for diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL) patients is currently available for clinical use as a laboratory-developed test (LDT) performed at Adaptive's CLIA-certified lab in Seattle, WA. clonoSEQ is CE-marked under IVDR in the EU. For the approved intended use in the EU under IVDR, please refer to the instructions for use, available on request. clonoSEQ leverages Adaptive Biotechnologies’ proprietary immune medicine platform to identify and quantify specific DNA sequences found in malignant cells, allowing clinicians to assess and monitor MRD during and after treatment. The test provides standardized, accurate, and sensitive measurement of MRD that allows physicians to predict patient outcomes, assess response to treatment, inform changes in therapy, monitor disease burden over time, and detect potential relapse early. Clinical practice guidelines in hematologic malignancies recognize that MRD status is a reliable indicator of clinical outcomes and response to therapy, and clinical outcomes have been shown to be strongly associated with MRD levels measured by clonoSEQ in patients diagnosed with CLL, MM, B-ALL and DLBCL. For important information about the FDA-cleared uses of clonoSEQ, including the full intended use, limitations, and detailed performance characteristics, please visit www.clonoSEQ.com/technical-summary. About Adaptive BiotechnologiesAdaptive Biotechnologies (“we” or “our”) is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed. We apply our platform to partner with biopharmaceutical companies, inform drug development, and develop clinical diagnostics across our two business areas: Minimal Residual Disease (MRD) and Immune Medicine. Our commercial products and clinical pipeline enable the diagnosis, monitoring, and treatment of diseases such as cancer, autoimmune disorders, and infectious diseases. Our goal is to develop and commercialize immune-driven clinical products tailored to each individual patient. Forward Looking Statements This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law. ADAPTIVE INVESTORSKarina Calzadilla, Vice President, Investor Relations201-396-1687investors@adaptivebiotech.com ADAPTIVE MEDIAErica Jones, Associate Director, Corporate Communications206-279-2423media@adaptivebiotech.com

Clinical ResultPhase 3ASH

07 Dec 2024

·www.prnewswire.com

New Research from Children's Hospital of Philadelphia to Transform Standard of Care Across the Globe for Newly Diagnosed Children with B-cell Acute Lymphoblastic Leukemia

Results will be presented at the 66th American Society of Hematology Annual Meeting PHILADELPHIA, Dec. 7, 2024 /PRNewswire/ -- Researchers at Children's Hospital of Philadelphia (CHOP) and the Children's Oncology Group (COG) announced the results of a Phase 3 study that demonstrated adding the bi-specific T-cell engager, blinatumomab, to chemotherapy for newly diagnosed National Cancer Institute (NCI) standard risk (SR) B-cell acute lymphoblastic leukemia (B-ALL) pediatric patients significantly improves survival outcomes. The results were published today in the New England Journal of Medicine and will be presented during the plenary session at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego on December 8. Continue Reading Stephen P. Hunger, MD David T. Teachey, MD Since its initial approval a decade ago as an addition to chemotherapy for children and adults with relapsed B-ALL, blinatumomab, a type of immunotherapy that treats certain kinds of leukemia by binding to cancer cells and immune cells, has already made a major impact on the B-ALL treatment landscape. However, relapsed B-ALL remains a major cause of childhood cancer-related deaths, with nearly half of relapses occurring in children with SR B-ALL. For this reason, researchers sought to determine if this regimen would be effective in children at the time of diagnosis. "Our team is dedicated to the global improvement of cure rates and decreasing side effects for children, adolescents and young adults," said Stephen P. Hunger, MD, a study co-author, former COG ALL Disease Committee Chair, Chief of CHOP's Division of Oncology and Director of CHOP's Center for Childhood Cancer Research. "This approach defines a new treatment standard for children newly diagnosed with B-ALL." In AALL173, the Phase 3 randomized trial, researchers evaluated whether two non-sequential 28-day blinatumomab cycles added to chemotherapy improved disease-free survival (DFS) in newly diagnosed SR B-ALL pediatric patients between June 2019 and June 2024. CHOP was the largest enrolling site for the study. SR average (SR-Avg) patients tend to have a lower white blood cell count and favorable genetic features at diagnosis, compared with SR high (SR-High) patients, who have a higher white blood cell count and specific genetic mutations that make the disease more aggressive and challenging to treat. Of those originally analyzed, 1,440 SR-Avg/SR-High patients, whose average age was four years-old, were randomized, including 835 SR-Avg and 605 SR-High. Overall, the three-year DFS was 96.0% for patients treated with chemotherapy plus blinatumomab compared with 87.9% for those treated with only chemotherapy, the current standard of care. Among SR-Avg patients, 3-year DFS was 97.5% for patients treated with blinatumomab compared with 90.2% for those treated with only chemotherapy. For SR-High patients, 3-year DFS was 94.1% for those treated with blinatumomab compared with 84.8% for those treated with only chemotherapy. "These findings mark a significant clinical advancement, cementing blinatumomab and chemotherapy together as the safest and most effective treatment for children with B-ALL," said David T. Teachey, MD, a study co-author, Chair of the Acute Lymphoblastic Leukemia Disease Committee in COG, and Director of Clinical Research at the Center for Childhood Cancer Research at CHOP. "Moving forward, we expect more findings on higher-risk pediatric patients, as well as a focus on improving access to this lifesaving treatment for all children and their families." This study was supported by grants from the National Institutes of Health/National Cancer Institute (U10CA180899; U20CA180886) and from the St. Baldrick's Foundation. Gupta et al. "Blinatumomab in standard risk pediatric B-acute lymphoblastic leukemia." NEJM. Online December 7, 2024. DOI: 10.1056/NEJMoa2411680. About Children's Hospital of Philadelphia: A non-profit, charitable organization, Children's Hospital of Philadelphia was founded in 1855 as the nation's first pediatric hospital. Through its long-standing commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals, and pioneering major research initiatives, the hospital has fostered many discoveries that have benefited children worldwide. Its pediatric research program is among the largest in the country. The institution has a well-established history of providing advanced pediatric care close to home through its CHOP Care Network, which includes more than 50 primary care practices, specialty care and surgical centers, urgent care centers, and community hospital alliances throughout Pennsylvania and New Jersey, as well as the Middleman Family Pavilion and its dedicated pediatric emergency department in King of Prussia. In addition, its unique family-centered care and public service programs have brought Children's Hospital of Philadelphia recognition as a leading advocate for children and adolescents. For more information, visit . Contact: Jennifer Lee Children's Hospital of Philadelphia (267) 426-6084 [email protected] SOURCE Children's Hospital of Philadelphia WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3ASHImmunotherapy

100 Deals associated with Blinatumomab

External Link

KEGG	Wiki	ATC	Drug Bank
D09325	Blinatumomab	L01XC19	DB09052

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
CD19-positive B-cell Precursor acute lymphoblastic leukemia	CN	Amgen, Inc.	02 Dec 2020
Burkitt Lymphoma	JP	Amgen, Inc.	21 Sep 2018
Acute Lymphoblastic Leukemia	EU	Amgen Europe BV	23 Nov 2015
Acute Lymphoblastic Leukemia	IS	Amgen Europe BV	23 Nov 2015
Acute Lymphoblastic Leukemia	LI	Amgen Europe BV	23 Nov 2015
Acute Lymphoblastic Leukemia	NO	Amgen Europe BV	23 Nov 2015
Pre B-cell acute lymphoblastic leukemia	US	Amgen, Inc.	03 Dec 2014

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Ph-Like Acute Lymphoblastic Leukemia	Phase 3	-	National Cancer Institute	28 Feb 2025
Philadelphia Chromosome Positive Leukemia	Phase 3	-	National Cancer Institute	28 Feb 2025
Philadelphia positive acute lymphocytic leukaemia	Phase 3	-	National Cancer Institute	28 Feb 2025
BCR-ABL1 positive Acute Lymphoblastic Leukemia	Phase 3	US	National Cancer Institute	25 Jan 2021
BCR-ABL1 positive Acute Lymphoblastic Leukemia	Phase 3	IL	National Cancer Institute	25 Jan 2021
BCR-ABL1 positive Acute Lymphoblastic Leukemia	Phase 3	PR	National Cancer Institute	25 Jan 2021
B lymphoblastic leukemia lymphoma	Phase 3	US	National Cancer Institute	03 Jul 2019
B lymphoblastic leukemia lymphoma	Phase 3	AU	National Cancer Institute	03 Jul 2019
B lymphoblastic leukemia lymphoma	Phase 3	CA	National Cancer Institute	03 Jul 2019
B lymphoblastic leukemia lymphoma	Phase 3	NZ	National Cancer Institute	03 Jul 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04521231 (ASH2024) Manual	Phase 1	Pre B-cell acute lymphoblastic leukemia	27	Subcutaneous Blinatumomab 250μg/500μgBlinatumomab 250μg/500μg	piuflvwgsf(vgdeovyfju) = iathfovnka sxqzhtfqzs (xjativkhyo ) View more	Positive	07 Dec 2024
NCT04521231 (ASH2024) Manual	Phase 1	Pre B-cell acute lymphoblastic leukemia	27	Subcutaneous Blinatumomab 500μg/1000μgBlinatumomab 500μg/1000μg	piuflvwgsf(vgdeovyfju) = ilglhhyskq sxqzhtfqzs (xjativkhyo ) View more	Positive	07 Dec 2024
NCT03263572 (Pubmed) Manual	Phase 2	Philadelphia positive acute lymphocytic leukaemia	60	Ponatinib and Blinatumomab	pafutlhdjs(vipajwjlri) = pzebvrtnzm rbonqcirfr (oyepbkbdls ) View more	Positive	19 Jul 2024
EULAR2024 Manual	Not Applicable	Rheumatoid Arthritis rheumatoid factor (RF) \| anti-citrullinated protein antibodies (ACPA)	6	Blinatumomab	qreigudtwm(fmoyquihlh) = blinatumomab therapy was safe and well tolerated, with brief increase in body temperature and acute phase proteins during first infusion but no signs of clinically relevant cytokine-release syndrome. oqqgaalowo (hhvigddnql )	Positive	05 Jun 2024
CCCG-ALL 2020 (EHA2024) Manual	Not Applicable	Pre B-cell acute lymphoblastic leukemia First line \| Consolidation MRD ≥ 10-2	12	Blinatumomab consolidation therapy	fzbrpzyweq(lfaowvftwq) = tuxfxekeeg elrihhaulg (fdtbbxssph )	Positive	14 May 2024
NCT06237192 (RALL-2016m, EHA2024) Manual	Not Applicable	Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia MRD-negative	44	blinatumomab00 mg/dayvenetoclax	whqsrwcpjt(usonneprvj) = gbyzwgclbh lkpaqofavw (qnecdlufnp ) View more	Positive	14 May 2024
NCT04994717 (Golden Gate, EHA2024) Manual	Phase 3	Pre B-cell acute lymphoblastic leukemia First line Ph-neg	14	Blinatumomab + LIC	vruucioymg(otcfvxreqv) = lffuyqvgbi jeatkhlngv (reileqgxyt ) View more	Positive	14 May 2024
ALLTogether1 DS (EHA2024) Manual	Phase 2	Pre B-cell acute lymphoblastic leukemia First line CD19 Positive	33	Blinatumomab	glnsebwllu(jhljhxbkmb) = ofwjctfhlb mlvvzywslx (rohjfiazxm ) View more	Positive	14 May 2024
ALLTogether1 DS (EHA2024) Manual	Phase 2		33	Chemotherapy regimens	glnsebwllu(jhljhxbkmb) = sjfocrjvyf mlvvzywslx (rohjfiazxm ) View more	Positive	14 May 2024
EHA2024	Not Applicable	Pre B-cell acute lymphoblastic leukemia	73	Shorten period of blinatumomab treatment	(wwsphztasm) = liwrlurzes jkfmteqipn (crdfeybmqi ) View more	Positive	14 May 2024
EHA2024	Not Applicable	Pre B-cell acute lymphoblastic leukemia	73	BINATUMOMAB (Sequential allo-HSCT)	(icmnyzyfmk) = cwxtldlixu rpbdvqzsfb (kaqpgfrcgl ) View more	Positive	14 May 2024
AYA-15 (EHA2024)	Not Applicable	Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia Consolidation CD19 \| CD3	22	Blinatumomab	qubpriacbv(udfckyvsrw) = 59% with only 9% having grade 2 or more csdtfhpskw (alydjqmolg ) View more	Positive	14 May 2024
EHA2024	Not Applicable	Philadelphia positive acute lymphocytic leukaemia t(9;22)	10	HyperCVAD-Blinatumomab-TKI combination	rdkhxhxnwh(brfiecwuwc) = One patient died from grade 3+ vascular toxicity of Ponatinib (acute limb ischemia) eojqlsaetn (colcjoxkeu ) View more	Positive	14 May 2024

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