- |||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma
Antibody immunotherapy treatment for adults with B‐acute lymphoblastic leukaemia–a real‐world analysis () - May 14, 2020 - Abstract #BSH2020BSH_214;
Inotuzumab ozogamicin (Ino) is recommended as an option for treating R/R CD22‐positive B‐cell precursor ALL irrespective of Ph status...In the R/R patients, toxicity in the form of cytokine release syndrome (CRS) was observed in 50% (3 of 6) of patients receiving Blina, and two thirds (67%) of these were grade 3/4; requiring Tocilizumab...A significant proportion of patients achieve morphological remission after 1 cycle substantiating the efficacy of these therapies as previously reported.1,2 Real‐world toxicity also appears comparable. Larger cohorts are needed to fully address the safety and efficacy of these agents in unselected patient cohorts.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Journal: Mini-HCVD plus inotuzumab plus or minus blinatumomab: Hype or hope? (Pubmed Central) - May 13, 2020
Larger cohorts are needed to fully address the safety and efficacy of these agents in unselected patient cohorts. No abstract available
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Journal: Perspective: Designing T-Cell Engagers With Better Therapeutic Windows. (Pubmed Central) - May 1, 2020
As of January 2020, blinatumomab remains the only approved TCE...The underlying conviction of the authors is that by taking corrective measures, TCEs can transform cancer therapy. Through openness, transparency, and much needed feedback from ongoing clinical studies, the field can continuously improve the design and effectiveness of next generation T-cell redirecting therapeutics.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Rapid and sensitive determination of cytokine release from cells without the need for sample transfer (Board Number: P140) - Apr 25, 2020 - Abstract #IMMUNOLOGY2020IMMUNOLOGY_1892;
In a cell model comprised of activated T cells and target Raji B cells induced for 20 h with increasing bispecific T-cell engager Blincyto, release of IL-2 and IFN-γ were observed with an EC50 of ~0.2 ng/ml and maximal S/B for IL-2 and IFN-γ of 82- and 168-fold, respectively. The implementation of this novel detection chemistry will enable rapid “add-and-read” assays for cytokine detection for both low- and high-throughput applications.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Bispecific anti-CD22 T-cell engager efficiently promotes cell-mediated cytotoxicity of lymphoma, leukemia and sarcoma targets. (Board Number: P1062) - Apr 25, 2020 - Abstract #IMMUNOLOGY2020IMMUNOLOGY_1540;
Blinatumomab, and FDA-approved BiTE, binds to CD19 on B cells and to CD3 on T cells, mediating killer-target cell contact and T cell activation that results in effective elimination of B cells...Accordingly, our CD22-BiTE mediated killing of HT1080 sarcoma cells in vitro. In conclusion, we report here the development of a new BiTE with killing activity against CD22+ malignancies which could represent a therapeutic option for B-cell malignancies and potentially solid tumors.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Promoting anti-tumor immunity via bispecific T cell engaging cytokine (biteokine) therapy (Board Number: P1312) - Apr 25, 2020 - Abstract #IMMUNOLOGY2020IMMUNOLOGY_864;
Currently, the FDA approved BiTE, Blinatumomab (Blin), provides an alternative to standard chemotherapy in patients with relapsed/refractory or MRD+ Acute Lymphoblastic Leukemia (ALL) and is in clinical trials for other B cell malignancies...Our preliminary results indicate that optimally lytic architectures favor high αCD3 to αCD19 ratios and are improved linearly with increasing IL-12. This work seeks to innovate and enhance bispecific T cell engager therapy with a modular platform that can be used broadly in the treatment of cancer and autoimmunity.
- |||||||||| Nailike (olverembatinib) / Ascentage Pharma, Takeda
Trial completion date, Trial primary completion date: HQP1351CU101: Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL (clinicaltrials.gov) - Apr 21, 2020
P1, N=30, Recruiting,
No abstract available Trial completion date: Oct 2021 --> Dec 2022 | Trial primary completion date: Oct 2020 --> Jun 2021
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Journal: T Cell-Activating Bispecific Antibodies in Cancer Therapy. (Pubmed Central) - Apr 14, 2020
The BsAb blinatumomab, for example, has specificity for the T cell-activating cell surface protein CD3 and the B cell Ag CD19...Future directions for BsAbs include combinations with a wide variety of both immunologic and nonimmunologic therapies. Defining their optimum clinical use is at early stages.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Clinical, Retrospective data, Journal, Real-World Evidence: Safety and efficacy of blinatumomab: a real world data. (Pubmed Central) - Apr 11, 2020
Median leukemia-free survival and overall survival were not reached in patients proceeding to alloSCT compared to 5.1 and 15.2 months, respectively, for patients who did not receive stem cell transplantation.Treatment was well tolerated with neurological events reported in two patients (10%) and GI events in three patients (14%). Cytokine storm was reported in four patients (19%).In conclusion, treatment with blinatumomab is effective and tolerable in adult patients with relapsed/refractory B-ALL outside of a clinical trial stetting.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Trial primary completion date, Minimal residual disease: PETHEMA-BLIN-01/PET069014 (BLIN-01) (clinicaltrials.gov) - Apr 7, 2020
P2, N=38, Recruiting,
Cytokine storm was reported in four patients (19%).In conclusion, treatment with blinatumomab is effective and tolerable in adult patients with relapsed/refractory B-ALL outside of a clinical trial stetting. Trial primary completion date: Jun 2023 --> Dec 2024
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis, Blincyto (blinatumomab) / Astellas, Amgen
A RARE CASE OF ALL RELAPSE: GRANULOCYTIC SARCOMA CAUSING BRACHIAL PLEXOPATHY IN A PEDIATRIC PATIENT () - Apr 3, 2020 - Abstract #ASPHO2020ASPHO_10;
A KMT2A gene rearrangement may have led to the unusual presentation of relapse in this patient. A nerve palsy/neuropathy presenting acutely in a patient with previous ALL diagnosis should prompt further work up to rule out neuroleukemiosis, with special attention paid to patients with KMT2A rearrangements as they may be at higher risk for developing GS.
- |||||||||| Iclusig (ponatinib) / Takeda, Otsuka, Incyte, Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Review, Journal, Residual disease: Evaluation and management of measurable residual disease in acute lymphoblastic leukemia. (Pubmed Central) - Mar 28, 2020
Furthermore, the incorporation of novel monoclonal antibodies or potent BCR-ABL1 tyrosine kinase inhibitors, such as ponatinib into frontline treatment may have the advantage of achieving higher rates of MRD negativity while minimizing chemotherapy-related toxicities. Many studies are therefore ongoing to determine whether this strategy can improve cure rates without the need for allogeneic stem cell transplantation.
- |||||||||| Review, Journal: Treatment of Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia. (Pubmed Central) - Mar 26, 2020
The probability of attaining this goal by a more potent TKIs like dasatinib or ponatinib is higher, thus we recommend the use of second- or third-generation TKIs over imatinib...Because of higher risk of relapses in the central nervous system, intrathecal chemoprophylaxis is mandatory for all patients. New strategies incorporating novel agents, such as antibody-drug conjugates, bispecific monoclonal antibodies, potent TKIs, and CAR T cells are under investigation.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Trial initiation date, Trial primary completion date, Minimal residual disease: OZM-097: Blinatumomab for MRD in Pre-B ALL Patients Following Stem Cell Transplant (clinicaltrials.gov) - Mar 25, 2020
P2, N=50, Not yet recruiting,
New strategies incorporating novel agents, such as antibody-drug conjugates, bispecific monoclonal antibodies, potent TKIs, and CAR T cells are under investigation. Initiation date: Sep 2019 --> Sep 2020 | Trial primary completion date: Sep 2021 --> Feb 2022
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Biomarker, Review, Journal, IO biomarker: Cytokine Release Syndrome With the Novel Treatments of Acute Lymphoblastic Leukemia: Pathophysiology, Prevention, and Treatment. (Pubmed Central) - Mar 22, 2020
T cell-based therapies (blinatumomab and CAR T cell therapy) have produced unprecedented responses in relapsed and refractory (r/r) acute lymphoblastic leukemia (ALL) but is accompanied with significant toxicities, of which one of the most common and serious is cytokine release syndrome (CRS)...Efforts have been initiated to define and grade cytokine release syndrome (CRS), to identify patients at risk, to describe biomarkers that predict onset and severity, to understand the pathophysiology, and to prevent and treat severe cases to reduce T cell immunotherapy-related morbidity and mortality. Optimizing the timing of T cell-based therapies in ALL, identifying new biomarkers, and investigating novel anti-cytokine agents that have anti-CRS activity are likely to be fruitful avenues of study.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Clinical, Journal: Acute Lymphoblastic Leukemia in the Older Adult. (Pubmed Central) - Mar 20, 2020
Immunotherapies such as chimeric antigen receptor-modified T-cells, the bispecific T-cell-engaging antibody targeting CD19 (blinatumomab), and the antibody-drug conjugate targeting CD22 (inotuzumab) have shown safety and exceptional activity even in advanced ALL, and the efficacy of these agents has been observed irrespective of patient age. Several promising studies tailored specifically toward older adults with ALL are ongoing, with the majority of them incorporating novel immunotherapies, targeted therapies, or third-generation tyrosine kinase inhibitors into the front-line treatment regimen.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Journal: Construction of a Mammalian IRES-based Expression Vector to Amplify a Bispecific Antibody; Blinatumomab. (Pubmed Central) - Mar 19, 2020
By positioning the DHFR downstream of BsAb gene and IRES, the transcription of the selection marker can depend on the successful transcription of the BsAb gene, which was located upstream in the expression construct. In this study, FC550A-1 vector was used as the backbone and DHFR selection marker was successfully combined with phiC31 integrase technology to generate a high-expressing construct for BsAb expression in CHO-DG44 cells in future studies.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Clinical, Review, Journal, IO Biomarker: Clinical trial update on bispecific antibodies, antibody-drug conjugates, and antibody-containing regimens for acute lymphoblastic leukemia. (Pubmed Central) - Mar 12, 2020
A novel low-intensity regimen, miniHCVD-INO-blinatumomab, appears to be less toxic and more effective than conventional intensive chemotherapy regimens. This review summarized new therapeutic researches of ALL and updated latest progress in clinical trials on bispecific antibodies, antibody-drug conjugates, and new regimens incorporating these novel antibodies.
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis, Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Clinical, Review, Journal, IO Biomarker: Immunotherapy in pediatric acute lymphoblastic leukemia. (Pubmed Central) - Mar 2, 2020
These strategies have also been tested in the frontline setting, and immunotherapy against a new ALL-associated antigen has been developed. Incorporating effective immunotherapy into ALL therapy would enable the intensity of conventional chemotherapy to be decreased and thereby reduce associated toxicity, leading to further improvement in survival and quality of life for patients with ALL.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Clinical, Journal: Successful use of blinatumomab in a patient with acute lymphoblastic leukemia and severe hepatic dysfunction. (Pubmed Central) - Feb 20, 2020
In this report, we describe the safe and effective use of blinatumomab in an adult patient with refractory Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia in the setting of severe hepatic dysfunction. Blinatumomab may represent a viable option to treat relapsed/refractory acute lymphoblastic leukemia in patients with significant hepatic dysfunction.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Clinical, Journal: Concomitant use of blinatumomab and donor lymphocyte infusion for mixed-phenotype acute leukemia: a case report with literature review. (Pubmed Central) - Feb 16, 2020
Here, we present a 51-year-old female with mixed phenotype acute leukemia who had a hematologic relapse 3 months after she received total body irradiation-based myeloablative allogeneic hematopoietic stem cell transplantation from an unrelated human leukocyte antigen matched (10/10) donor and achieved complete remission with minimal residual disease negativity by multi-parameter flow cytometry using the combination of blinatumomab and DLI. To the best of our knowledge, this is the first report to describe the use of blinatumomab and DLI combination therapy in the treatment of B/myeloid mixed phenotype acute leukemia.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Opdivo (nivolumab) / BMS, Imbruvica (ibrutinib) / AbbVie, J&J
Enrollment closed, Enrollment change: Ibrutinib, Nivolumab and Blinatumomab in Richter Transformation (clinicaltrials.gov) - Feb 10, 2020
P2, N=10, Active, not recruiting,
To the best of our knowledge, this is the first report to describe the use of blinatumomab and DLI combination therapy in the treatment of B/myeloid mixed phenotype acute leukemia. Recruiting --> Active, not recruiting | N=21 --> 10
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