Blincyto (blinatumomab) News

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|||||||||| CLN-978 / Cullinan Oncology
CLN-978, a novel CD19/CD3/HSA T cell engager with extended serum half-life, is effective against lymphoma cells expressing very low levels of CD19 (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_1332;
P1
The characteristics of CLN-978 may translate into high response rates and longer response duration in NHL patients expressing normal and very low levels of CD19 on malignant B cells. CLN-978 is currently in Phase 1 clinical development (NCT05879744).

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Comparison of preclinical efficacy between CD19 CAR-T and CD3 (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_658;
Conclusions Both CD19 CAR-T and Blinatumomab demonstrated a similar in vitro tumor suppressive effect and an initial in vivo response rate. However, CAR-T showcased a greater advantage in maintaining remission due to their more sustained pharmacokinetics and better in vivo proliferation capacity.

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Preclinical CD3-based mouse models for evaluation of bi-specific T-cell engager antibodies (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_395;
Finally, bispecific anti-human CD3/CD19 antibody blinatumomab dose-dependently inhibited MC38-hCD19 tumor growth in B-hCD3E mice, and bispecific anti-human CD3/BCMA antibody dose-dependently inhibited MC38-hBCMA tumor growth in B-hCD3EDG mice...These mice present a useful model for accelerated in vivo evaluation of anti-human CD3 therapeutics. Our growing list of CD3-based humanized mice includes B-hCD3E/hCD28, B-hCD3E/h4

||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
New P2 trial:  Study of Blinatumomab Administration in Chinese Pediatric Participants With Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia (R/R B-ALL) (clinicaltrials.gov) -  Sep 26, 2023
P2, N=18, Not yet recruiting,  Sponsor: Amgen

||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Trial completion date, Trial primary completion date:  NCI-2017-00596: Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia (clinicaltrials.gov) -  Sep 22, 2023
P2, N=80, Recruiting,  Sponsor: M.D. Anderson Cancer Center
Our growing list of CD3-based humanized mice includes B-hCD3E/hCD28, B-hCD3E/h4 Trial completion date: Nov 2023 --> Nov 2026 | Trial primary completion date: Nov 2023 --> Nov 2026

||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, blinatumomab subcutaneous / Amgen
Trial completion date, Trial primary completion date:  A Study of Subcutaneous Blinatumomab Administration in Acute Lymphoblastic Leukemia (ALL) Patients (clinicaltrials.gov) -  Sep 14, 2023
P1/2, N=245, Recruiting,  Sponsor: Amgen
Trial completion date: Nov 2023 --> Nov 2026 | Trial primary completion date: Nov 2023 --> Nov 2026 Trial completion date: Aug 2028 --> Mar 2029 | Trial primary completion date: Oct 2026 --> Jun 2027

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Journal, Real-world evidence, Residual disease, Real-world: 15-color highly sensitive flow cytometry assay for post anti-CD19 targeted therapy (anti-CD19-CAR-T and blinatumomab) measurable residual disease assessment in B-lymphoblastic leukemia/lymphoma: Real-world applicability and challenges. (Pubmed Central) - Sep 14, 2023
We standardized a highly sensitive 15-color BMRD assay with a non-CD19-based gating strategy for patients receiving anti-CD19 immunotherapy. We also described the immunophenotypes of recurrently occurring low-level populations that can be misinterpreted as MRD in real-world practice.

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Biomarker, Clinical, Observational data, Retrospective data, Review, Journal: Relapse/Refractory Paediatric B-ALL Case with CD19 Phenotype Switching Indicating the Importance of Appropriate Diagnostic Approach and Targeted Treatment Adjustment-Case Report. (Pubmed Central) - Sep 13, 2023
We explore possible reasons for the promotion of CD19-negative cell selection, including discrete mutations and anti-CD19 treatment, which is gaining importance as targeted therapies such as blinatumomab enter standard treatment protocols...The patient died in October 2019 from disease progression. The case highlights the importance of in-depth molecular diagnostics and monitoring of relapse/recurrent ALL cases to identify and manage risk factors during treatment.

||||||||||  Zolinza (vorinostat) / Merck (MSD), ziftomenib (KO-539) / Kura Oncology, Blincyto (blinatumomab) / Astellas, Amgen
Trial initiation date:  TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II (clinicaltrials.gov) -  Sep 13, 2023
P1/2, N=90, Not yet recruiting,  Sponsor: Stanford University
The case highlights the importance of in-depth molecular diagnostics and monitoring of relapse/recurrent ALL cases to identify and manage risk factors during treatment. Initiation date: Jul 2023 --> Nov 2023

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Journal, Immune cell: Blinatumomab differentially modulates peripheral blood and bone marrow immune cell repertoire: A Campus ALL study. (Pubmed Central) - Sep 13, 2023
Of note, BM immune T-cell subsets showed a broader post-treatment subversion, including the modulation of markers associated with a T-cell-exhausted phenotype. In conclusion, our study indicates that blinatumomab differentially modulates the PB and BM immune cell repertoire, which may have relevant clinical implications in the therapeutic setting.

||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Trial completion date, Trial primary completion date, Combination therapy, Checkpoint inhibition, IO biomarker:  NCI-2016-01300: Blinatumomab and Nivolumab With or Without Ipilimumab in Treating Patients With Poor-Risk Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia (clinicaltrials.gov) -  Sep 11, 2023
P1, N=24, Active, not recruiting,  Sponsor: National Cancer Institute (NCI)
In conclusion, our study indicates that blinatumomab differentially modulates the PB and BM immune cell repertoire, which may have relevant clinical implications in the therapeutic setting. Trial completion date: Nov 2023 --> Sep 2024 | Trial primary completion date: Nov 2023 --> May 2023

||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
Trial completion, Combination therapy:  HARBOUR: Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adults With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL) (clinicaltrials.gov) -  Sep 11, 2023
P1b, N=31, Completed,  Sponsor: Amgen
Trial completion date: Nov 2023 --> Sep 2024 | Trial primary completion date: Nov 2023 --> May 2023 Active, not recruiting --> Completed

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Review, Journal: Positioning blinatumomab in the frontline of adult B-cell acute lymphoblastic leukemia treatment. (Pubmed Central) - Sep 7, 2023
The early use of blinatumomab has established success in Ph-negative and Ph-positive B-ALL, and this has extended to older adults with ALL who have historically had substantially inferior outcomes compared to their pediatric and young adult counterparts. Herein we will review the current data describing the early use of blinatumomab in newly diagnosed adults with B-cell ALL and future directions.

|||||||||| Iclusig (ponatinib) / Takeda, Otsuka, Incyte, Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
The Role of CNS Prophylaxis in the Era of Contemporary Therapy in Adults With Acute Lymphoblastic Leukemia () - Aug 31, 2023 - Abstract #SOHO2023SOHO_946;
Herein we will review the current data describing the early use of blinatumomab in newly diagnosed adults with B-cell ALL and future directions. In patients without CNS involvement at diagnosis, for Philadelphia chromosome (Ph) negative B-lineage ALL, the recommended numbers of IT therapy range from 8

|||||||||| Updates on Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia () - Aug 31, 2023 - Abstract #SOHO2023SOHO_945;
Introduction Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia (ALL) was historically associated with poor outcomes when treated with chemotherapy followed by allogeneic stem cell transplantation (ASCT).1 Four different BCR::ABL1 tyrosine kinase inhibitors (TKIs) have been combined with chemotherapy in patients with Ph-positive ALL, leading to improved outcomes: imatinib, dasatinib, nilotinib, and ponatinib...Future studies combining asciminib or olverembatinib with blinatumomab in the frontline setting are warranted...These strategies have reduced the incidence of toxicities and mitigated the need for ASCT. The incorporation of NGS for the detection of MRD can help select patients who may be candidates for TKI discontinuation.

|||||||||| NHL and the Immunotherapy Era () - Aug 31, 2023 - Abstract #SOHO2023SOHO_730;
Rituximab, a CD20 monoclonal antibody is used for malignant B-cell immunotherapy treatment...Immune- checkpoint inhibitors, such as nivolumab and pembrolizumab, innovated the treatment of solid tumors and relapsed/refractory lymphoma with unprecedented results...First bispecific T-cell engager (BiTE), blinatumomab, and ongoing studies and trials for dual antibody molecules, dual-affinity re-targeting (DART) proteins. This review highlights these 3 immunotherapy classes for relapsed/refractory NHL and mechanism of action, clinical efficacy, and toxicities.

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Efficacy and Safety of Single?Agent Blinatumomab as Salvage Therapy in Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia (B?ALL): Real?Life Experience () - Aug 31, 2023 - Abstract #SOHO2023SOHO_704;
Our findings support the effectiveness and safety of blinatumomab in adult patients with r/r B-ALL in a single-center real-world setting. The identification of prognostic factors can help guide treatment decisions and optimize patient outcomes.

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
T Cells Under the Influence of Blinatumomab Masquerading as Blasts (LEVEL 3, GENERAL ASSEMBLY) - Aug 31, 2023 - Abstract #SOHO2023SOHO_654;
Our case perfectly illustrates this model for NAE-related to blinatumomab; the T-cell population's dynamics strengthen this association. Given >10% Grade 3 or 4 NAEs with cellular therapies, interruption of T cell adhesion to the CSF may be a strategy worth exploring to minimize future NAEs.

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Efficacy and Safety of Single?Agent Blinatumomab as Salvage Therapy in Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia (B?ALL): Real?Life Experience () - Aug 31, 2023 - Abstract #SOHO2023SOHO_646;
Our findings support the effectiveness and safety of blinatumomab in adult patients with r/r B-ALL in a single-center real-world setting. The identification of prognostic factors can help guide treatment decisions and optimize patient outcomes.

|||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Blincyto (blinatumomab) / Astellas, Amgen, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Clinical Outcomes of Therapy?Related Acute Leukemia (t?AL): A Single?Center Retrospective Analysis () - Aug 31, 2023 - Abstract #SOHO2023SOHO_450;
Favorable cytogenetic t-AL is a rare occurrence. Interestingly, in our population of t-AL, we have 50% of patients with favorable risk t-AL: 4 t-APL and 1 t-CBF-AML.

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Mylotarg (gemtuzumab ozogamicin) / UCB, PDL, Pfizer
Acute Leukemia (AL) and Pregnancy: Single?Institution Experience () - Aug 31, 2023 - Abstract #SOHO2023SOHO_383;
Treating AL during pregnancy is challenging; a multidisciplinary team of maternal-fetal medicine and malignant hematology specialists is critical to improve outcomes. Standard leukemia IC regimens can be safely administered during the second or third trimester of pregnancy.

||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, blinatumomab subcutaneous / Amgen
Enrollment change:  A Study of Subcutaneous Blinatumomab Administration in Acute Lymphoblastic Leukemia (ALL) Patients (clinicaltrials.gov) -  Aug 31, 2023
P1/2, N=245, Recruiting,  Sponsor: Amgen
Standard leukemia IC regimens can be safely administered during the second or third trimester of pregnancy. N=130 --> 245

||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
Enrollment closed:  Blinatumomab and Tyrosine Kinase Inhibitor Therapy in People With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (clinicaltrials.gov) -  Aug 31, 2023
P2, N=17, Active, not recruiting,  Sponsor: Memorial Sloan Kettering Cancer Center
N=130 --> 245 Recruiting --> Active, not recruiting

||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Keytruda (pembrolizumab) / Merck (MSD)
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy:  Blinatumomab and Pembrolizumab for Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia With High Marrow Lymphoblasts (clinicaltrials.gov) -  Aug 24, 2023
P1/2, N=16, Active, not recruiting,  Sponsor: University of California, San Diego
Recruiting --> Active, not recruiting Terminated --> Active, not recruiting | Trial completion date: Apr 2022 --> Dec 2025 | Trial primary completion date: Apr 2022 --> Dec 2025

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Journal: Short-course blinatumomab for refractory/relapse precursor B acute lymphoblastic leukemia in children. (Pubmed Central) - Aug 21, 2023
No significant short-term survival benefits were observed after bridging HSCT with blinatumomab. In developing countries, a short course of blinatumomab can achieve satisfactory outcomes, while reducing household costs and saving medical resources.

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Review, Journal, Combination therapy, IO biomarker: Combination therapies for the optimisation of Bispecific T-cell Engagers in cancer treatment. (Pubmed Central) - Aug 21, 2023
Furthermore, there is evidence that BiTE therapy itself can increase immune checkpoint expression, and this is thought to be a major escape mechanism for the BiTE therapy blinatumomab...Study of these combinations is needed to expand the use of BiTEs in solid malignancies. This review covers the rationale, preclinical evidence and any clinical trials for these combination therapies and a few other less-studied combinations.

||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
Trial completion date, Trial primary completion date, Minimal residual disease:  Blinatumomab in Treating Patients With B-cell Acute Lymphoblastic Leukemia With Minimal Residual Disease (clinicaltrials.gov) -  Aug 18, 2023
P2, N=40, Active, not recruiting,  Sponsor: M.D. Anderson Cancer Center
This review covers the rationale, preclinical evidence and any clinical trials for these combination therapies and a few other less-studied combinations. Trial completion date: Sep 2023 --> Sep 2024 | Trial primary completion date: Sep 2023 --> Sep 2024

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Biomarker, Clinical, Observational data, Retrospective data, Review, Clinical Trial,Phase III, Journal, Post-transplantation: Successful Blinatumomab treatment in an allogeneic hematopoietic stem cell transplant recipient with EBV-related post-transplant lymphoproliferative disorder: A case report and literature review. (Pubmed Central) - Aug 14, 2023
In the present report, we describe the case of an EBV-PTLD patient who was successfully treated with blinatumomab and received maintenance therapy consisting of venetoclax combined with azacytidine (AZA). The present case highlights the potential utility of blinatumomab as an effective treatment option for individuals with high-risk EBV-PTLD, although further explanation of the optimal dosing and treatment duration is warranted in the future.

|||||||||| INVASIVE PULMONARY ASPERGILLOSIS: IS MULTIMODAL THERAPY THE WAY FORWARD? (Convention Center Exhibit Hall) - Aug 4, 2023 - Abstract #CHEST2023CHEST_1061;

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Review, Journal: Incidence of CD19-negative relapse after CD19-targeted immunotherapy in R/R BCP acute lymphoblastic leukemia: a review. (Pubmed Central) - Aug 1, 2023
The median (range) duration of follow-up was 29.3 (17.4-50.8) and 20.4 (6.9-49.0) months for publications on blinatumomab (n?=?10) and CAR T-cell therapies (n?=?23), respectively. There is a need for standardized reporting of CD19 antigen status in the setting of relapse following novel immunotherapies to inform clinical practice.

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Journal, Mismatch repair: Constitutional Mismatch Repair Deficiency Syndrome as a Cause of Numerous Malignancies in a Teenage Patient-A Case Report. (Pubmed Central) - Aug 1, 2023
Due to the almost exceeded total dose of anthracyclines, the patient's treatment included blinatumomab, and subsequently, he was qualified for allogeneic hematopoietic cell transplantation. The patient remains in complete remission for 11 months after allogeneic hematopoietic stem cell transplantation under the care of the transplant center.

|||||||||| Review, Journal, Trispecific, Immune cell: Bi- and trispecific immune cell engagers for immunotherapy of hematological malignancies. (Pubmed Central) - Jul 31, 2023
The first T cell engager (the anti-CD19 blinatumomab) was approved by the FDA in 2014, but no other one hit the market until 2022. Now the field is gaining momentum, with three approvals in 2022 and 2023 (as of May): the anti-CD20

|||||||||| Kymriah (tisagenlecleucel-T) / Novartis, Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Journal, HEOR, Real-world evidence, Real-world: Real-world treatment patterns of novel drugs in relapsed or refractory acute lymphoblastic leukemia patients in Japan. (Pubmed Central) - Jul 31, 2023
A small number of patients were prescribed sequential treatment of inotuzumab-to-blinatumomab or blinatumomab-to-inotuzumab (20.3% and 10.5%, respectively). This study revealed inotuzumab and blinatumomab treatment features in Japan.

|||||||||| I meant great data for Ponatinib + Blinatumomab and very exciting studies Asciminib + Dasatinib by Dr. Luskin and Inotuzumab + Dasatinib or Ponatinib by Dr. Patel. The Ph+ ALL field has leapt forward remarkably over the last decade! (Twitter) - Jul 29, 2023

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Review, Journal: Harnessing the Immune System: Current and Emerging Immunotherapy Strategies for Pediatric Acute Lymphoblastic Leukemia. (Pubmed Central) - Jul 29, 2023
The incorporation of these novel immunotherapies into ALL treatment, either as monotherapy or in combination with cytotoxic chemotherapy, has demonstrated promising potential to augment outcomes while decreasing toxicity. However, we also highlight the many challenges we still face and the research critically needed to achieve our goals for cure in children.

||||||||||  Scemblix (asciminib) / Novartis, Blincyto (blinatumomab) / Astellas, Amgen
Enrollment open, Combination therapy:  ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML (clinicaltrials.gov) -  Jul 27, 2023
P1, N=40, Recruiting,  Sponsor: Marlise Luskin, MD
However, we also highlight the many challenges we still face and the research critically needed to achieve our goals for cure in children. Active, not recruiting --> Recruiting

||||||||||  Blincyto (blinatumomab) / Astellas, Amgen
Trial completion date, Trial primary completion date:  Blinatumomab Plus HLA-Mismatched Cellular Therapy for Relapsed/Refractory CD19+ ALL (clinicaltrials.gov) -  Jul 20, 2023
P1, N=10, Active, not recruiting,  Sponsor: Cedars-Sinai Medical Center
Active, not recruiting --> Recruiting Trial completion date: Feb 2024 --> Mar 2025 | Trial primary completion date: Jul 2023 --> Mar 2023

||||||||||  Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Enrollment open, Trial initiation date:  Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab (cRIB) for Relapsed Therapy for Pediatric With B-Cell Lineage Acute Lymphocytic Leukemia (clinicaltrials.gov) -  Jul 20, 2023
P2, N=27, Recruiting,  Sponsor: M.D. Anderson Cancer Center
Trial completion date: Feb 2024 --> Mar 2025 | Trial primary completion date: Jul 2023 --> Mar 2023 Not yet recruiting --> Recruiting | Initiation date: Apr 2024 --> Jul 2023

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Journal: Flow cell sorting followed by PCR-based clonality testing may assist in questionable diagnosis and monitoring of acute lymphoblastic leukemia. (Pubmed Central) - Jul 18, 2023
The technique is easy to implement in diagnostic and monitoring workflows, as it does not require isolation of a large number of cells and knowledge of individual clonal rearrangements. We believe it provides important information for further treatment.

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Journal, IO biomarker: Blinatumomab as salvage therapy in patients with relapsed/refractory B-ALL who have failed/progressed after anti-CD19-CAR T therapy. (Pubmed Central) - Jul 11, 2023
Blinatumomab could be an effective and safe salvage therapy in patients with R/R B-ALL who failed/progressed after anti-CD19-CAR T therapy, even in R/R B-ALL patients without high expression of CD19 in B-ALL cells, patients with CNS leukemia or co-infection.Key messagesSome R/R B-ALL patients did not respond to anti-CD19 CAR T-cell therapy or had a disease progression again. Effective and safe salvage therapy for such patients remains to be explored.Blinatumomab could be an effective and safe salvage therapy in patients with R/R B-ALL who failed/progressed after anti-CD19-CAR T therapy, even in patients without high expression of CD19 in B-ALL cells.Blinatumomab could be an effective and safe salvage therapy in patients with R/R B-ALL who failed/progressed after anti-CD19-CAR T therapy, even in patients with CNS leukemia or co-infection.

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Journal: Blinatumomab Is Safe and Efficacious in Infant Acute Lymphoblastic Leukemia. (Pubmed Central) - Jul 10, 2023
Effective and safe salvage therapy for such patients remains to be explored.Blinatumomab could be an effective and safe salvage therapy in patients with R/R B-ALL who failed/progressed after anti-CD19-CAR T therapy, even in patients without high expression of CD19 in B-ALL cells.Blinatumomab could be an effective and safe salvage therapy in patients with R/R B-ALL who failed/progressed after anti-CD19-CAR T therapy, even in patients with CNS leukemia or co-infection. No toxic effects that led to treatment discontinuation or death were observed with blinatumomab.

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Clinical, CAR T-Cell Therapy, Minimal residual disease: Do we have any data for CAR T cells in MRD positive patients after blinatumomab induction? (Twitter) - Jul 8, 2023

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Review, Journal: Novel strategies to prevent and overcome relapse after allogeneic hematopoietic cell transplantation in acute lymphoblastic leukemia. (Pubmed Central) - Jun 30, 2023
However, relapse post-transplant is still occurring and constitutes a common cause of treatment failure in B-ALL. The present review aims to discuss the novel strategies and therapies used to prevent and overcome relapse post allo-HCT in patients with ALL, focusing on the role of tyrosine kinase inhibitors in Philadelphia chromosome positive B-ALL, the role of innovative agents such as blinatumomab and inotuzumab ozogamicin, and finally the role of cellular therapy.

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Journal: A simplified function-first method for the discovery and optimization of bispecific immune engaging antibodies. (Pubmed Central) - Jun 26, 2023
Blinatumomab, a CD19-CD3 BiTE is now a widely used therapy for relapsed B-cell malignancies, and similar BiTE therapeutics have shown promise for treating various other forms of cancer...By testing several novel CD3-targeting scFv elements for activity in EGFRvIII-targeted BiTEs, we were able to identify highly active BiTE molecules with desirable functional activity for downstream development. In summary, BiTE-J presents a low cost, high-throughput method for the rapid assessment of novel BiTE molecules without the need for purification and quantification.

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
FDA event, Interview, Minimal residual disease: 🔥 FDA Gives Full Approval to Blinatumomab 🔥 in MRD-Positive B-Cell ALLC. Get up to speed with @MRLitzow exclusive @OncologyTube ASH interview with slides on this treatment https://t.co/DhrRQejTG6 (Twitter) - Jun 22, 2023

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Retrospective data, Journal: CD19-negative relapse in adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia following treatment with blinatumomab-a post hoc analysis. (Pubmed Central) - Jun 22, 2023
In summary, BiTE-J presents a low cost, high-throughput method for the rapid assessment of novel BiTE molecules without the need for purification and quantification. No abstract available

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Review, Journal, PD(L)-1 Biomarker, IO biomarker: T-Cell Engagers in Solid Cancers-Current Landscape and Future Directions. (Pubmed Central) - Jun 22, 2023
Bi-/trispecific antibody technology is a novel pharmaceutical approach to facilitate the engagement of effector immune cells to potentially multiple cancer epitopes, e.g., the recently approved blinatumomab...In contrast, the targeting of intracellular TAAs such as mutant RAS and TP53 may lead to fewer off-target toxicities while still achieving the desired antitumor efficacy (on-target toxicity). Here, we provide a comprehensive review on the emerging field of bi-/tri-specific T-cell engagers and potential therapeutic opportunities.

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Approach to Ph-Like ALL (LEVEL 3, GENERAL ASSEMBLY) - Jun 21, 2023 - Abstract #SOHO2023SOHO_91;
Here, we provide a comprehensive review on the emerging field of bi-/tri-specific T-cell engagers and potential therapeutic opportunities. However, long-term efficacy remains to be determined and it is under evaluation in clinical trials.1,22,23 Preclinical and more recent clinical studies have shown variable activity of JAK inhibitors in JAK-STAT activating ALL17,24 and the need to simultaneously inhibit multiple pathways, including phosphoinositide 3-kinase (PI3K)/mTOR or mitogen-activated protein kinase (MEK)/ receptor tyrosine kinases (e.g. FLT3) to block the growth of leukemic blasts.25

|||||||||| Iclusig (ponatinib) / Takeda, Otsuka, Incyte, Blincyto (blinatumomab) / Astellas, Amgen
MRD in Ph+ ALL: How Do You Measure It and What Does It Mean? (Level 3, Room 320C) - Jun 21, 2023 - Abstract #SOHO2023SOHO_6;
This has been driven largely by the use of later-generation BCR::ABL1 tyrosine kinase inhibitors (TKIs) such as ponatinib,1 and more recently, the use of chemotherapyfree combination regimens with blinatumomab plus a TKI.2,3 These newer Ph+ ALL regimens are able to achieve rapid and deep reduction in disease burden, reflected by high rates of early measurable residual disease (MRD) negativity. While it may be reasonable to consider discontinuing TKI therapy in a patient with Ph+ ALL who has achieved long-term CMR, can the same approach be applied to a patient who is NGS MRD negativity at a sensitivity of 10

|||||||||| Kymriah (tisagenlecleucel-T) / Novartis
Review, Journal, HEOR, Cost-effectiveness, Cost effectiveness: A systematic review on the cost-effectiveness assessment of tisagenlecleucel for refractory or relapsing B-cell acute lymphoblastic leukemia (R/R B-ALL) treatment in children and young adults. (Pubmed Central) - Jun 21, 2023
However, tisagenlecleucel performed well on the ICER, not exceeding $100 000/QALY. It was also found that the advanced therapy product was more effective than the conventional small molecule and biological drugs, in terms of life years and QALY gained.



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