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29 Diseases |  |
78 Trials |
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78 Trials |  |
3560 News |  |
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- || Blincyto (blinatumomab) / Astellas, Amgen
Trial completion: Blinatumomab Consolidation Post Autologous Stem Cell Transplantation in Patients With Diffuse Large B-Cell Lymphoma (DLBCL) (clinicaltrials.gov) - Nov 28, 2023
P1, N=14, Completed, Sponsor: Washington University School of Medicine
Active, not recruiting --> Completed
- | Scemblix (asciminib) / Novartis, Blincyto (blinatumomab) / Astellas, Amgen
Trial completion date, Trial primary completion date: ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML (clinicaltrials.gov) - Nov 28, 2023
P1, N=40, Recruiting, Sponsor: Marlise Luskin, MD
Active, not recruiting --> Completed Trial completion date: Nov 2024 --> Nov 2026 | Trial primary completion date: Nov 2023 --> Nov 2025
- || Nailike (olverembatinib) / Ascentage Pharma, Takeda
Trial primary completion date: HQP1351CU101: Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL (clinicaltrials.gov) - Nov 27, 2023
P1, N=62, Recruiting, Sponsor: Ascentage Pharma Group Inc.
Trial completion date: Nov 2024 --> Nov 2026 | Trial primary completion date: Nov 2023 --> Nov 2025 Trial primary completion date: Jan 2023 --> Jan 2024
- | Blincyto (blinatumomab) / Astellas, Amgen
Biomarker, Journal, IO biomarker: Pretreatment blast-to-lymphocyte ratio as a prognostic marker for CD19/CD3-bispecific T cell-engaging antibodies (blinatumomab) treatment against relapsed or refractory B-precursor acute lymphoblastic leukemia. (Pubmed Central) - Nov 27, 2023
P3
To examine this possibility, we conducted a post hoc analysis using data from the TOWER Clinical Trials (NCT02013167). Multivariate analysis showed that, along with the treatment groups, each of the following was independently correlated with superior progression-free survival: salvage-treatment phase, allogeneic stem cell transplantation, and pre-treatment ratio of bone marrow blasts-to-peripheral blood lymphocytes?<?25.
- | Blincyto (blinatumomab) / Astellas, Amgen, Darzalex (daratumumab) / J&J, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Retrospective data, Journal, HEOR, Cost of care: Health Care Resource Utilization and Total Costs of Care for Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia in the United States: A Retrospective Claims Analysis. (Pubmed Central) - Nov 19, 2023
Those treated with blinatumomab or inotuzumab incurred higher total costs within each LoT compared with the overall R/R B-ALL cohort. Alternative therapies with longer duration of remission are urgently needed, and HRU should be considered for future studies examining the optimal sequencing of therapy.
- Blincyto (blinatumomab) / Astellas, Amgen
Blinatumomab prior HSCT in MRD-positive pediatric ALL patients () - Nov 18, 2023 - Abstract #APBMT2023APBMT_32;
- | Blincyto (blinatumomab) / Astellas, Amgen
Journal: Blinatumomab for First-Line Treatment of Children and Young Persons With B-ALL. (Pubmed Central) - Nov 15, 2023
Alternative therapies with longer duration of remission are urgently needed, and HRU should be considered for future studies examining the optimal sequencing of therapy. Blina is safe and effective in first-line treatment of chemotherapy-intolerant CYP with ALL.
- || Review, Journal, CAR T-Cell Therapy: CAR T-Cells for the Treatment of B-Cell Acute Lymphoblastic Leukemia. (Pubmed Central) - Nov 14, 2023
The advent of novel immunologic agents such as blinatumomab and inotuzumab has changed the treatment landscape of B-ALL...Two CD19-targeting CAR T-cells were approved by the Food and Drug Administration and the European Medicines Agency for the treatment of relapsed and/or refractory B-ALL. In this review, we review the available data regarding CD19-targeting CAR T-cells with their safety profile as well as the mechanism of resistance to these agents and the way to overcome this resistance.
- || Blincyto (blinatumomab) / Astellas, Amgen
Review, Journal: T-Cell Engaging Antibodies in Diffuse Large B Cell Lymphoma-An Update. (Pubmed Central) - Nov 14, 2023
Since the approval of blinatumomab for R/R acute lymphoblastic leukemia, there has been significant development in novel TCEAbs...This review examines the development and mechanism of action of these TCEAbs, and the available published data from clinical trials. Their role in the treatment of DLBCL, the management of therapy-related adverse events, and the mechanisms of resistance will also be discussed.
- | Blincyto (blinatumomab) / Astellas, Amgen
Journal: Editorial: Immunotherapy for hematological malignancies in children. (Pubmed Central) - Nov 13, 2023
Their role in the treatment of DLBCL, the management of therapy-related adverse events, and the mechanisms of resistance will also be discussed. No abstract available
- | Blincyto (blinatumomab) / Astellas, Amgen
Trial completion date, Trial initiation date, Trial primary completion date: Study of Blinatumomab Administration in Chinese Pediatric Participants With Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia (R/R B-ALL) (clinicaltrials.gov) - Nov 13, 2023
P2, N=18, Not yet recruiting, Sponsor: Amgen
No abstract available Trial completion date: Mar 2027 --> Jun 2027 | Initiation date: Mar 2024 --> Jun 2024 | Trial primary completion date: Oct 2025 --> Feb 2026
- Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Consolidation with First and Second Allogeneic Transplants in Adults with Relapsed/Refractory B-ALL Following Response to CD19CAR T Cell Therapy (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6445;
Conclusions : We report low early NRM and favorable survival outcomes for alloHCT consolidation post response to CD19CAR T cell therapy in heavily pre-treated adult pts with r/r B-ALL, despite 5 median prior lines of therapy and Ph-like disease in over half of pts. Outcomes for second alloHCT were promising in this setting and comparable to first alloHCT.
- Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute
Venetoclax+Azacytidine Followed By Modified BuCy Conditioning Regimen for High Risk or Refractory/Relapsed Acute Lymphoblastic Leukemia and High Risk Myelodysplastic Syndromes (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6369;
P2, P2/3
The VA combined with the mBuCy proves to be a effective and safe conditioning regimen for high-risk ALL and MDS patients. However, more patients are needed for follow-up and validation.
- Impact of Salvage and Bridging Therapy in Adult Patients with Refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL) Referred for Anti-CD19 CAR T-Cell Therapy: An Intention to Treat Analysis (Halls G-H (San Diego Convention Center)) - Nov 3, 2023 - Abstract #ASH2023ASH_6333;
These results suggest that the potentially synergistic impact of bridging therapy may be mediated more by the modulation exerted by BT on the proliferative kinetics of the disease rather than on the absolute tumour burden of the patient. More detailed results on the independent impact of each type of BT will be provided in the final presentation.
- UCART22 / Cellectis
Updated Results of the Phase I BALLI-01 Trial of UCART22 Process 2 (P2), an Anti-CD22 Allogeneic CAR-T Cell Product Manufactured By Cellectis Biologics, in Patients with Relapsed or Refracto... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6304;
Pt 1 is a 17yo female with B-ALL with a hypodiploid karyotype and a germline TP53 mutation whose disease had previously failed to respond to multiagent chemotherapy, blinatumomab (blina), inotuzumab (ino), venetoclax (ven), allogeneic hematopoietic stem cell transplantation (HSCT), and autologous CD19 CAR T-cell therapy (CAR19) x2. Pt 2 is a 68yo female with Ph-negative B-ALL who relapsed with CD19-low disease after multiagent chemotherapy, ino, and blina.
- Blincyto (blinatumomab) / Astellas, Amgen
Exploring the Heterogeneity of Response to Blinatumomab in High-Risk Philadelphia-Negative B-Cell Precursor Acute Lymphoblastic Leukemia: An Analysis from the QUEST Sub-Study of the Graall-2... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5786;
In adult patients with Ph-negative BCP-ALL who experience an overall benefit of BLIN in consolidation, the present study reveals a heterogeneous landscape of response among genetic entities. Larger prospective studies should further explore this heterogeneity to refine implementation of BLIN in frontline setting.
- Blincyto (blinatumomab) / Astellas, Amgen
LONG-TERM Results of the Frontline Dasatinib/Blinatumomabprotocol (D-ALBA, GIMEMA LAL2116) for Adult Ph+ Acutelymphoblastic Leukemia (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5683;
These results pave the way for a new era in the treatment of adult Ph+ ALL patients. Vignetti et al, Blood 2007 Fo
- Iclusig (ponatinib) / Takeda, Otsuka, Incyte, Blincyto (blinatumomab) / Astellas, Amgen
Comparison between Dasatinib-Blinatumomab Vs Ponatinib-Blinatumomab Chemo-Free Strategy for Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia Patients. Preliminary Results of the Gimema ALLL2... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5682;
So far, the benefit of the current protocol appears to rely on a lower relapse rate, with only 1 relapse being observed to date, while in the same time period 3 relapses were documented with the dasatinib-blinatumomab combination. Further details will be provided.
- Iclusig (ponatinib) / Takeda, Otsuka, Incyte, Blincyto (blinatumomab) / Astellas, Amgen
Consolidation with Ponatinib Plus Sequential Blinatumomab and Chemotherapy after Low Intensity Dasatinib-Based Induction in Adults with Philadelphia Chromosome-Positive Acute Lymphoblastic L... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5680;
Introduction : Dasatinib plus prednisone is a standard induction approach for adults with Philadelphia Chromosome positive (Ph+) ALL known to result in high remission rates with minimal toxicity, however optimal post-remission therapy has not been determined...Concurrent with TKI, patients could also receive blina for one or two cycles (at discretion of treating clinician), followed by up to four cycles of consolidative chemotherapy alternating between high-dose methotrexate (1.5g/m 2 ) and intermediate-dose cytarabine (1g/m 2 x 6 doses)...The optimal number of blina cycles given post-remission is unclear, though we observed favorable outcomes in patients receiving a median of only 1 cycle, and maximum of 2 cycles. Favorable outcomes despite the low rate of allogeneic SCT (21%) seen in our cohort suggest that SCT may be safely avoided for some patients who receive ponatinib plus blina and chemotherapy-based consolidation.
- Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Updated Results from a Phase II Study of Hyper-CVAD, with or without Inotuzumab Ozogamicin, and Sequential Blinatumomab in Patients with Newly Diagnosed B-Cell Acute Lymphoblastic Leukemia (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5678;
Pts with CD20+ disease (=1% cells) received 8 doses of ofatumumab (2000 mg) or rituximab (375 mg/m2)...One pt discontinued blinatumomab due to a related adverse event (grade 2 encephalopathy and dysphasia). No pts discontinued INO due to toxicity, and no cases of veno-occlusive disease have been observed.
- Blincyto (blinatumomab) / Astellas, Amgen
Reduced-Dose Chemotherapy Followed By Blinatumomab As Induction Therapy in Treatment of Newly Diagnosed Philadelphia Chromosome-Negative B-Cell Precursor Acute Lymphoblastic Leukemia - Inter... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5676;
P2
These preliminary results indicate that the reduced intensity chemotherapy followed by blinatumomab is an effective regimen in adults with newly diagnosed Ph-negative BCP-ALL, resulting in favorable response rates, deep remission, and low-grade treatment-related AEs. These promising findings may provide a rationale for integrating blinatumomab into future induction therapy recommendations.
- Blincyto (blinatumomab) / Astellas, Amgen, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Retrospective Analysis of Adolescent Young Adult Patients with Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma Treated with the CALGB 10403 Regimen Since Completion of Trial Enrollmen... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5673;
Previously treated patients, except with hydroxyurea, steroids, or one dose of single-agent therapy were excluded; patients given rituximab for CD20+ B-ALL were included...Forty-four patients (44%) were taken off C10403 while in CR; 20 (20%) for allogeneic HCT, 23 (23%) for non-HCT alternative treatments including Hyper-CVAD or blinatumomab, and 1 (1%) for patient preference...While only 31% of patients completed the regimen through end of maintenance, a majority of patients who came off regimen either underwent consolidative HCT or alternative therapy while in CR. These data confirm the pediatric regimen as an excellent front-line option in AYA ALL.
- Blincyto (blinatumomab) / Astellas, Amgen
Philadelphia-like B-Cell Acute Lymphoblastic Leukemia in a Largely Hispanic Population: Disease Features and Outcomes in the Era of Immunotherapy a Single Institutional Study (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5639;
Ph-like B- Cell ALL represents a high-risk disease subtype of adult B-ALL, with poor EFS and frequent treatment failure. CRLF2 translocation confers worse CIR and EFS within Ph-like patients and requires novel treatment approaches.
- Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
The Impact of Adding Rituximab to the Standard Chemotherapy + TKI Regimen in Adults with Philadelphia-Positive B Acute Lymphoblastic Leukemia: A Multicenter Retrospective Study (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5635;
Rituximab is not associated with a higher incidence of infections, ICU admission, early mortality, or deaths in remission. Although there is no significant benefit observed, there is a trend towards better OS with the addition of rituximab to the standard treatment of CD20+ Ph+ ALL.
- Blincyto (blinatumomab) / Astellas, Amgen
Project Evolve, Evaluation of Lineage Switch (LS), an International Initiative: Preliminary Results Reveal Dismal Outcomes in Patients with LS (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5633;
Project EVOLVE provides the largest dataset of patients with LS to date. This systematic, international effort reveals substantial complexity and variability in diagnosing and managing LS.
- Blincyto (blinatumomab) / Astellas, Amgen
A Propensity Score Weighting Analysis Emphasizes the Progress of the Gimema Approach in Adult Ph-Positive Acute Lymphoblastic Leukemia in the TKI Era (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5631;
The marked improvement observed with the LAL2116 trial is ascribable to the consolidation strategy based on blinatumomab, since LAL2116 shared with the earlier LAL1509 and LAL1205 protocols the same induction strategy (dasatinib). It also appears evident that a center-specific post-induction strategy - as in LAL1205 - is not beneficial.
- Ovastat (treosulfan) / Medac, Medexus, Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
[CANCELED] Outcome of Children with B-Cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL) with Hypodiploidy or BCR-ABL1 Fusion Given Allogeneic Hematopoietic Stem Cell Transplantation (HSCT): Results from the Prospective Forum Study (Ballroom 20CD (San Diego Convention Center)) - Nov 3, 2023 - Abstract #ASH2023ASH_5238;
P2/3
CIR and EFS reached plateaus beyond 3 y post-HSCT, indicating that approximately two-thirds of these pts can be cured by HSCT with low rates of treatment-related mortality. Pts with BCRABL achieved favorable outcomes without the need for long-term or lifelong TKI therapy.
- Tecartus (brexucabtagene autoleucel) / Gilead
Real-World Outcomes of Brexucabtagene Autoleucel (brexu-cel) for Relapsed or Refractory (R/R) Adult B-Cell Acute Lymphoblastic Leukemia (B-cell ALL): Evidence from the CIBMTR Registry (SDCC - Room 6CF) - Nov 3, 2023 - Abstract #ASH2023ASH_5214;
Pts received a median of 4 prior lines of therapy (range 1-13); 46% had prior inotuzumab and 58% had prior blinatumomab...Treatment for CRS and/or ICANS consisted mainly of tocilizumab (67%) and corticosteroids (51%)...Updated data with longer follow-up will be reported at the time of presentation. *First and second authors are equal contributors
- Blincyto (blinatumomab) / Astellas, Amgen
Blinatumomab in Combination with Immune Checkpoint Inhibitors (ICIs) of PD-1 and CTLA-4 in Adult Patients with Relapsed/Refractory (R/R) CD19 Positive B-Cell Acute Lymphoblastic Leukemia (AL... (Grand Hyatt - Grand Hall D) - Nov 3, 2023 - Abstract #ASH2023ASH_5140;
Long-term survival was promising in comparison to prior results with blina monotherapy, especially following consolidation with alloBMT. A randomized trial of blina +/- nivolumab is needed to confirm the benefit of this combination.
- Scemblix (asciminib) / Novartis
A Phase I Study of Asciminib (ABL001) in Combination with Dasatinib and Prednisone for BCR-ABL1-Positive ALL and Blast Phase CML in Adults (Grand Hyatt - Grand Hall D) - Nov 3, 2023 - Abstract #ASH2023ASH_5139;
P1
Both patients with imatinib-refractory CML-LBC progressed (C9, C3). Of those with ALL, 8 bridged to SCT after 2-8 cycles; 2 elected local care (C5, C7); 1 transitioned to ponatinib for inadequate response plus recurrent DAS pulmonary toxicity (C4); 6 remained on study treatment until disease progression (C4
- Blincyto (blinatumomab) / Astellas, Amgen
Dose Reduced Chemotherapy in Sequence with Blinatumomab for Newly Diagnosed Older Patients with Ph/BCR::ABL Negative B-Precursor Adult Lymphoblastic Leukemia (ALL): Preliminary Results of th... (Grand Hyatt - Grand Hall D) - Nov 3, 2023 - Abstract #ASH2023ASH_5138;
P3
An ongoing randomized trial (NCT04994717) compares an even more dose reduced combination of Blina and chemotherapy with standard of care. This is an independent academic trial initiated by the GMALL Study Group which received free supply of Blinatumomab and financial support by Amgen.
- Blincyto (blinatumomab) / Astellas, Amgen
Sequential Chemotherapy and Blinatumomab to Improve Minimal Residual Disease in Adult Ph- B-Lineage Acute Lymphoblastic Leukemia. Final Results of the Phase II Gimema LAL2317 Trial (Grand Hyatt - Grand Hall C) - Nov 3, 2023 - Abstract #ASH2023ASH_4977;
This is an independent academic trial initiated by the GMALL Study Group which received free supply of Blinatumomab and financial support by Amgen. We designed a phase II trial (GIMEMA LAL2317) for adult Ph- CD19+ B-lineage ALL (Ph- B-ALL) consisting of a pediatric chemotherapy backbone
- Blincyto (blinatumomab) / Astellas, Amgen
Pediatric Patients with High-Risk B-Cell ALL in First Complete Remission May Benefit from Less Toxic Immunotherapy with Blinatumomab (Grand Hyatt - Grand Hall C) - Nov 3, 2023 - Abstract #ASH2023ASH_4976;
We have demonstrated that the toxicity profile of Blinatumomab is much more favorable as compared to the intensive chemotherapy approach using HR-blocks. If upcoming analyses of outcome data will show no inferiority of the EA, blinatumomab replacement of some of the intensive chemotherapy blocks will become the new standard of care for treatment if newly diagnosed patients with HR B-ALL.
- Zolinza (vorinostat) / Merck (MSD), ziftomenib (KO-539) / Kura Oncology, Blincyto (blinatumomab) / Astellas, Amgen
Outcome of Infants Treated on Total Therapy for Infants with Acute Lymphoblastic Leukemia I: Results from a Non-Randomized Multi-Center Study (Grand Hyatt - Grand Hall C) - Nov 3, 2023 - Abstract #ASH2023ASH_4974;
P1/2
In this study, bortezomib and vorinostat were incorporated into an ALL chemotherapy backbone containing dexamethasone, mitoxantrone, and pegasparaginase during induction and reinduction chemotherapy cycles...Following induction intensification with cyclophosphamide, cytarabine, and mercaptopurine, 77% and 66% of all patients and KMT2Ar patients respectively were MRD negative at the time of count recovery...Although the study was not powered to evaluate outcomes, EFS and OS in KMT2Ar patients suggest a clinical signal worth pursuing given the low proportion of patients transplanted in first remission. The successor study, TINI 2 (NCT05848687), will build upon the bortezomib/vorinostat backbone by incorporating 2 cycles of blinatumomab and the menin inhibitor ziftomenib in combination with chemotherapy during reinduction.
- Blincyto (blinatumomab) / Astellas, Amgen, Keytruda (pembrolizumab) / Merck (MSD), Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Outcomes and Toxicities after Allogeneic Hematopoietic Cell Transplant for Remission Consolidation or Relapse Therapy after CD19 Chimeric Antigen Receptor T Cell Therapy in Children and Youn... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4727;
For children who were able to undergo HCT following a post-CART19 relapse, of which 77% were in CR3 or later, DFS and OS were also favorable. The majority became long term survivors and all events occurred within 1 year after HCT.
- Blincyto (blinatumomab) / Astellas, Amgen
Evaluating Blinatumomab Treatment Adoption in Varied Resource Settings Using the RE-AIM Framework (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4670;
Conclusion Successful implementation and collaboration with local multidisciplinary teams is a critical predecessor to establishing effectiveness and improving future global access to complex, novel therapies such as blinatumomab. Systematic application of established implementation measures, such as RE-AIM, can improve reporting of rich implementation data and inform strategies to improve the long-term adoption and maintenance of these effective therapies in the real world.
- Blincyto (blinatumomab) / Astellas, Amgen
A Phase IB/II Study of Blinatumomab in Patients with B-Cell Acute Lymphoblastic Leukemia (ALL) and B-Cell Non-Hodgkin Lymphoma (NHL) As Post-Allogeneic Blood or Marrow Transplant (alloBMT) R... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4532;
Initial survival outcomes are promising with the majority of relapses involving the CNS. A randomized trial of maintenance with blina after alloBMT with PTCy is needed to confirm efficacy in this high-risk population.
- Tecartus (brexucabtagene autoleucel) / Gilead
Bridging Therapy in Adults with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia Receiving Standard of Care Brexucabtagene Autoleucel: Results from the Real-World Outcomes Collaborati... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4448;
In our real-world analysis, adults with R/R B-ALL receiving bridging therapy had a higher disease burden at baseline. Despite greater baseline disease, there were no significant differences in toxicity and day 28 response in those receiving bridging therapy vs. not.
- Tecartus (brexucabtagene autoleucel) / Gilead
Efficacy and Tolerance of Brexucabtagene Autoleucel in Adults with Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia : A Graall Study from the Descar-T Registry (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4444;
All patients received fludarabine and cyclophosphamide as LD...Number of prior treatment lines, prior inotuzumab, prior blinatumomab, or pre-LD BM blast% were not associated with outcome...Conclusion : This multicenter real-life study confirms the efficacy and acceptable safety profile of brexu-cel in adult patients with R/R BCP-ALL. It also suggests that patients with CNS involvement, that were not eligible to ZUMA-3 study, have a limited benefit of brexu-cel when compared to other patients.
- Blincyto (blinatumomab) / Astellas, Amgen, CD22/CD19 CAR T / The First Affiliated Hospital of Soochow University
Safety and Efficacy of CD22/ CD19 CAR-T and Auto-HSCT "Sandwich" Strategy As Consolidation Therapy for Ph Negative B Cell Acute Lymphoblastic Leukemia (Halls G-H (San Diego Convention Center)) - Nov 3, 2023 - Abstract #ASH2023ASH_4426;
P1/2
It also suggests that patients with CNS involvement, that were not eligible to ZUMA-3 study, have a limited benefit of brexu-cel when compared to other patients. Afterwards, autologous CAR T-cells targeting CD22 and CD19 (CAR-T 1, co-stimulatory molecule was 4-1BB and infusion dose was 5
- CART22 / University of Pennsylvania
IL-10 Levels Differentially Regulate IFNg Signaling of CART19 and CART22 (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4375;
P1, P1/2
First, IL-10 levels are significantly higher in CART22 pts at pre-infusion, suggesting that previous immunotherapy has caused an upregulation of this anti-inflammatory cytokine. Second, we show that IL-10 levels have a differential impact on IFN?
- Blincyto (blinatumomab) / Astellas, Amgen, Tecvayli (teclistamab) / Genmab, J&J
Cardiovascular Toxicities Associated with Bispecific T-Cell Engagers (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_3833;
Heart failure and myocarditis in particular may portend worse outcomes. These safety signals warrant clinical vigilance and further investigation of their mechanisms, optimal surveillance strategies, and treatment options.
- Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Phase 2 Trial of Mini-Hyper-CVD Plus Inotuzumab Ozogamicin, with or without Blinatumomab, in Older Patients with Newly Diagnosed Philadelphia Chromosome-Negative B-Cell Acute Lymphoblastic L... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_3829;
Eight doses of rituximab 375mg/m 2 were given on D1, 8 of C1-4 if CD20 was =20% by flow cytometry...Ursodeoxycholic acid was given to all patients...Maintenance was initially with vincristine 2mg D1, prednisolone 50mg daily D1-5, 6-mercaptopurine 50mg BID & MTX 10mg/m 2 weekly (POMP) for three years...Conclusion Older patients with ND Ph-negative ALL treated with mHCVD plus InO, with or without blina had excellent response rates and deep remissions. However, further adjustment of the regimen is needed, especially in patients =70 years.
- Blincyto (blinatumomab) / Astellas, Amgen
Assessment of Outcomes of Consolidation Therapy By Number of Cycles of Blinatumomab Received in Newly Diagnosed Measurable Residual Disease Negative Patients with B-Lineage Acute Lymphoblast... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_3828;
This represents a new standard of care for pts aged 30-70 years with BCR::ABL1 negative ALL. The optimal dose and number of cycles is however unknown.
- Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute
Mini-Hyper-CVD Plus Venetoclax for Treatment of Older Adults with Newly Diagnosed Ph-Negative B-ALL or T-ALL (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_3826;
P1/2
We hypothesized that VEN plus dose-reduced hyper-CVD (cyclophosphamide, vincristine, dexamethasone) chemotherapy would be well tolerated and effective in older pts...Eight B-ALL pts had received prior chemotherapy for multiple myeloma (n=6; n=4 auto HSCT, n=5 lenalidomide), diffuse large B-cell lymphoma (n=1, RCHOP), and breast cancer (n=1, docetaxel, carboplatin, trastuzumab)...Conclusion In this ongoing study, the addition of VEN to hyper-CVD in newly diagnosed ALL was well tolerated with encouraging responses. A future amendment will incorporate blinatumomab consolidation for pts with B-ALL.
- Koselugo (selumetinib) / Merck (MSD), AstraZeneca
The MEK Inhibitor Selumetinib in Combination with Dexamethasone Leads to Responses in Adult and Pediatric Patients with Relapsed RAS-Pathway Mutated Acute Lymphoblastic Leukemia: Results of ... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_3825;
P1/2
Initially, the trial suffered from frequent SAEs concerning infections, which lead to a total of 3 urgent safety measures in 2018 and 2019, including lowering the dose of dexamethasone in the 2 nd half of cycle 1, mandating fluoroquinolone and co-trimoxazole prophylaxis and finally changing continuous dexamethasone to pulses. The response data with 44% of patients achieving a CR is promising and will need to be further evaluated in the context of targeted treatment approaches for RAS-altered leukemias, especially for relapsed T-ALL.
- Iclusig (ponatinib) / Takeda, Otsuka, Incyte, Blincyto (blinatumomab) / Astellas, Amgen
A Phase II Study of Low-Intensity Chemotherapy (Mini-Hyper-CVD) and Ponatinib Followed By Blinatumomab and Ponatinib in Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leu... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_3819;
The response data with 44% of patients achieving a CR is promising and will need to be further evaluated in the context of targeted treatment approaches for RAS-altered leukemias, especially for relapsed T-ALL. Four cycles (C) of mini-HCVD alternating with methotrexate (MTX) + cytarabine were followed by blina 28
- Doptelet (avatrombopag) / SOBI
Efficacy and Safety of Avatrombopag on Thrombocytopenia after Chemotherapy in Acute Leukaemia (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_3811;
Avatrombopag is effective on increasing platelet counts in patients with acute leukaemia after chemotherapy, with a good safety profile. It is a suitable therapeutic option for thrombocytopenia after chemotherapy.
- Iclusig (ponatinib) / Takeda, Otsuka, Incyte, Blincyto (blinatumomab) / Astellas, Amgen
Chemotherapy-Free Combination of Blinatumomab and Ponatinib in Adults with Newly Diagnosed Philadelphia Chromosome (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_3776;
Conclusions The chemotherapy-free combination of blinatumomab and ponatinib is safe and effective in newly diagnosed Ph-positive ALL, with high rates of MRD negativity. Encouraging duration of remission and OS has been observed without the need for HSCT.
- Blincyto (blinatumomab) / Astellas, Amgen
Single-Cell Transcriptomic Profiling of T Cells from Blinatumomab-Treated Patients with B-Cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL) Reveals Circulating CD8 T Cell Subsets Associa... (Grand Hyatt - Grand Hall D) - Nov 3, 2023 - Abstract #ASH2023ASH_3279;
Encouraging duration of remission and OS has been observed without the need for HSCT. The dots represent the observed logFC, the horizontal line the bootstrapped 95%Confidence Intervals; PTGDR2= prostaglandin D2 receptor 2; ns= not significant B) Differentially expressed genes in Non Responders vs Responders CD8 pos na