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- 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.
- Imbruvica (ibrutinib) / AbbVie, J&J, narazaciclib (ON 123300) / Onconova
Narazaciclib, a Differentiated CDK4/6 Antagonist, Prolongs Cell Cycle Arrest and Metabolomic Reprogramming, Enabling Restoration of Ibrutinib Sensitivity in Btki-Resistant Mantle Cell Lympho... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5611;
In conclusion, our findings demonstrate that narazaciclib is safe and effective as a single agent in preclinical models of MCL, including BTKi-resistant cases. Its combination with ibrutinib achieved a synergistic tumoricidal effect in vitro and in vivo , accelerating cell cycle blockade and reverting the metabolic reprogramming characterizing MCL refractoriness to BTKi therapy.
- Soliris (eculizumab) / AstraZeneca, Bekemv (eculizumab biosimilar) / Amgen
Efficacy of Parallel and Crossover Analysis As Well As Pharmacokinetic Similarity Were Confirmed between ABP 959 and Eculizumab Reference Product in Patients with PNH (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5517;
Additionally, analyses of serum total and unbound PK concentrations for patients with PNH further demonstrated PK similarity between ABP 959 and eculizumab RP. The results of this study, along with previously demonstrated analytical, non-clinical, clinical PK/PD in healthy adults, and efficacy and safety evaluations in PNH patients, further support a demonstration of no clinically meaningful differences between ABP 959 and eculizumab RP.
- Nplate (romiplostim) / Amgen, Kyowa Kirin
Treatment and Follow-up Data for Young Patients with a Gne Defect and Congenital Thrombocytopenia (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5379;
Of particular interest is the effectiveness of romiplostim in ameliorating thrombocytopenia in these cases. Both siblings in our study exhibited stable, acceptable platelet counts in response to this therapy, suggesting that romiplostim might offer a promising therapeutic strategy for managing congenital thrombocytopenia linked to GNE mutations.
- Doptelet (avatrombopag) / SOBI
Avatrombopag in Immune Thrombocytopenia (ITP). Real-Life Experience of Its Use in Hospitals within the Community of Madrid, Spain (AVAMAD STUDY) (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5377;
In addition, it reduces the need for salvage therapy and has a low adverse effect profile. A larger number of patients and a longer follow-up are needed to verify these results and to answer some questions such as whether it is possible to discontinue AVA treatment after response and the percentage of patients with sustained response following AVA discontinuation.
- Nplate (romiplostim) / Amgen, Kyowa Kirin, Promacta (eltrombopag) / Novartis
Real World Practices of Thrombopoietin Receptor Agonist Use and Discontinuation in Pediatric Patients with Immune Thrombocytopenia (ITP): A Single Center Retrospective Review (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5376;
TPO-RA dose was weaned at a faster rate in patients who fully weaned their TPO-RA compared to patients who were partially weaned. This data should be validated in a larger study.
- Nplate (romiplostim) / Amgen, Kyowa Kirin, Doptelet (avatrombopag) / SOBI, Promacta (eltrombopag) / Novartis
Interim Analysis of Treatment Satisfaction from a Prospective Phase 4 Study in Adult Immune Thrombocytopenia (ITP) Subjects after Switching from Eltrombopag or Romiplostim to Avatrombopag (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5370;
P4
Despite high patient satisfaction scores at BL from prior therapy (ELT or ROMI), patients reported higher satisfaction following a switch to AVA across all domains of the TSQM (effectiveness, side effects, convenience, and global satisfaction) over 90 days. In a population of patients who were generally responding to TPO-RAs prior to a switch to AVA, mean/median PCs were also either improved or maintained with AVA treatment for the duration of the study (reported in a separate abstract submission), suggesting that some patients may experience sustained effectiveness paired with enhanced overall treatment satisfaction when switching from ELT or ROMI.
- Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Clinical and Economic Burden of Illness in Patients with Persistent or Chronic Primary Immune Thrombocytopenia Treated with TPO-Ras and Rituximab (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5369;
All-cause hospitalization was high in this population. Further studies are needed to understand long-term clinical and economic outcomes among ITP patients.
- Nplate (romiplostim) / Amgen, Kyowa Kirin, Doptelet (avatrombopag) / SOBI, Promacta (eltrombopag) / Novartis
Real-World Use, Effectiveness and Safety of Romiplostim, Eltrombopag and Avatrombopag in Immune Thrombocytopenia: Data from the Norwegian ITP Registry (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5368;
Moreover, trust of clinicians towards TPO-RAs is increasing in recent years, as these agents begin to be chosen in earlier lines. Safety profiles were excellent, thrombosis and bone marrow fibrosis were rarely found.
- 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.
- Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
Excellent Outcomes of HLA Matched Related Donor Transplant for Adults with Severe Sickle Cell Disease Using a Non-Myeloablative Conditioning with Thiotepa and Post-Transplant Cyclophosphamid... (SDCC - Ballroom 20AB) - Nov 3, 2023 - Abstract #ASH2023ASH_5229;
P=N/A
GVHD prophylaxis included PTCy 100 mg/kg, mycophenolate mofetil (MMF), and sirolimus. Stem cell source included bone marrow (BM) mobilized with filgrastim (5-10
- 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.
- Nplate (romiplostim) / Amgen, Kyowa Kirin
Impact of Romiplostim on Overall Survival in Chemotherapy Induced Thrombocytopenia (SDCC - Room 25) - Nov 3, 2023 - Abstract #ASH2023ASH_4948;
CONCLUSION In this retrospective exact-matched cohort analysis of patients treated with romiplostim for CIT, survival was inferior compared to patients receiving G-CSF alone. We acknowledge the limitations of single-center retrospective cohort analysis, but these findings highlight the urgent need to establish clinical benefit of thrombopoietin receptor agonists in the management of CIT.
- 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?
- Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Final Results of a Phase I/II Trial of Carfilzomib + R-CHOP for Frontline Treatment of Patients with Non-Germinal Center Diffuse Large B-Cell Lymphoma (DLBCL) (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4017;
KR-CHOP can be delivered safely, without excess cardiac toxicity or peripheral neuropathy. The superior PFS and OS rates for Pts with non-GC DLBCL vs. controls receiving R-CHOP are encouraging but should be interpreted with caution due to inherent selection bias in clinical trial populations.
- 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.
- Ibrance (palbociclib) / Pfizer, Zydelig (idelalisib) / Gilead, Imbruvica (ibrutinib) / AbbVie, J&J
Combination of CDK4/6 Inhibitor Palbociclib and PI3K Inhibitor Idelalisib Synergistically Induces an Anti-Tumor Effect in B-Cell Lymphoma and Overcomes Ibrutinib Resistance (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_3774;
Finally, the combination treatment also showed synergistic anti-tumor activity in multiple tumor-bearing mice models. Conclusion : The combination of CDK4/6 inhibitor palbociclib and PI3K inhibitor idelalisib synergistically induced anti-tumor activity in B-cell lymphoma through downregulation of PLK1 expression, suggested a new combination direction for the treatment of B-NHL and even BTK inhibitor-resistant patients.
- Anti-Leukemic Effects of CK1? Degrader As Monotherapy and in Combination with Targeted Drugs (Halls G-H (San Diego Convention Center)) - Nov 3, 2023 - Abstract #ASH2023ASH_3746;
Substrates of CK1? include various proteins important in cancer and regulate multiple survival pathways such as p53, Wnt, autophagy and NF-
- Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, navtemadlin (KRT-232) / Kartos Therap
Navtemadlin, a Novel MDM2 Inhibitor, Potentiated Venetoclax-Induced Antitumor Efficacy in TP53 Wild-Type Acute Myeloid Leukemia (AML) (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_3729;
Nvtm combined with ven significantly enhanced these effects. Importantly, this combination blocked stromal cell-mediated (contact and soluble factors) cytoprotection.
- Tavalisse (fostamatinib) / Rigel, Kissei
Efficacy and Safety of Fostamatinib for Immune Thrombocytopenia in Clinical Practice in Spain: Interim Results of Fostames, Our National Fostamatinib Registry (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_3525;
However, fostamatinib proved to be effective and well tolerated in unselected patients with primary and secondary ITP. The association of fostamatinib with other drugs or its use in earlier lines of therapy may be associated with higher platelet response rates.
- Nplate (romiplostim) / Amgen, Kyowa Kirin, Promacta (eltrombopag) / Novartis
Interim Analysis of Platelet Response in a Prospective Phase 4 Study in Adult Immune Thrombocytopenia (ITP) Subjects after Switching from Eltrombopag (ELT) or Romiplostim (ROMI) to Avatrombo... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_3511;
P4
In a population of patients who were generally responding to TPO-RAs prior to a switch to AVA, mean/median PCs were either improved or maintained with AVA treatment over 90 days. Importantly, patient satisfaction was also higher across each domain of the TSQM-9 with AVA treatment (convenience, global satisfaction, safety, and effectiveness) than with the prior TPO-RA (results reported in related abstract submission) suggesting that some patients may experience sustained effectiveness paired with enhanced overall treatment satisfaction when switching from ELT or ROMI.
- sevuparin (DF-02) / Modus Therap, Mahidol Oxford Tropical Medicine Research Unit, Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
The Heparinoid Sevuparin Improves Anemia and Kidney Status in a Mouse Model of Chronic Kidney Disease (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_3390;
Our data in this mouse CKD model add new insights to the role of hepcidin in the development of CKD anemia over time. Furthermore, the results are promising and support further mechanistic and clinical studies to elucidate the therapeutic role for sevuparin as a treatment in anemia of inflammatory and/or chronic diseases in monotherapy or in combination with EPO and to explore its role in kidney protection.
- 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;
Furthermore, the results are promising and support further mechanistic and clinical studies to elucidate the therapeutic role for sevuparin as a treatment in anemia of inflammatory and/or chronic diseases in monotherapy or in combination with EPO and to explore its role in kidney protection. 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
- Blincyto (blinatumomab) / Astellas, Amgen
Unraveling the Mechanism of Action of Bispecific T-Cell Engagers in B-Cell Acute Lymphoblastic Leukemia Using Advanced Single-Cell Multiomics (Grand Hyatt - Grand Hall D) - Nov 3, 2023 - Abstract #ASH2023ASH_3278;
Conclusions We present an advanced single cell dissection of blinatumomab-induced target-effector interaction, providing novel insights into the mechanism of action and TME dynamics to guide patient selection and next generation BiTEs. A larger patients
- Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Loss of p53 Impairs Death Receptor Expression and Confers Resistance to CD19-Directed CAR T-Cell Therapy in B-Cell Precursor Acute Lymphoblastic Leukemia (Grand Hyatt - Grand Hall D) - Nov 3, 2023 - Abstract #ASH2023ASH_3277;
Conclusions Loss of p53 impairs expression of CD95/Fas and DR5/TRAILR2, thereby protecting ALL cells from CAR T induced cell death. In addition, our results indicate that the p53-controlled expression of these receptors may be exploited to increase the efficacy of CAR T-cell therapy in p53-proficient patients.
- Blincyto (blinatumomab) / Astellas, Amgen
In-Depth Immune Profiling in Children with BCP-ALL within the AIEOP-BFM ALL 2017 Study (Grand Hyatt - Grand Hall D) - Nov 3, 2023 - Abstract #ASH2023ASH_3274;
The international multicenter frontline therapy trial AIEOP-BFM ALL 2017 prospectively randomizes CD19-targeting T-cell engager blinatumomab (BLN) against standard of care (SOC) to improve outcomes in pediatric patients (pts) with B-cell precursor acute lymphoblastic leukemia (BCP-ALL) stratified for high (HR) and medium (MR) risks of relapse...Here, we report until know undescribed effect of BLN on T-cell compartment. Upcoming clinical data, which will be correlated with obtained immune profiles will answer the open question regarding the clinical relevance of these findings, and shed light into the mechanisms determining response to BLN, for its maximum benefit in childhood ALL.