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- Blenrep (belantamab mafodotin-blmf) / GSK
Long-Term Safety and Efficacy Results of Belantamab Mafodotin Plus Lenalidomide and Dexamethasone in Transplant Ineligible Patients with Newly Diagnosed Multiple Myeloma: An Updated Part 1 A... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6218;
P1/2
Meanwhile, a very promising clinical activity is observed, with rapid, deep and durable responses across all dose levels. Consequently, after validation with bigger pt numbers, this novel combination may well be a very attractive frontline option for this vulnerable and difficult-to-treat pt population.
- WVT078 / Novartis
Initial Results from a Phase 1 Dose-Escalation Study of WVT078, a BCMA (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6205;
P1
Consequently, after validation with bigger pt numbers, this novel combination may well be a very attractive frontline option for this vulnerable and difficult-to-treat pt population. Introduction: WVT078, a potent anti
- Single Cell Multi-Omic Correlation of Single Nucleotide Variants, Copy Number Variation and Surface Epitopes for Clonal Profiling of Myeloma (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6166;
Conclusion This high-resolution, single cell assay offers a potential new modality for the diagnosis and surveillance of patients with suspected MGUS, SGUS or high-risk MM. We have demonstrated: 1) exceptional results from cryopreserved human specimens, 2) the ability to use genetic lesion profiling to positively identify subclonal MM and, most importantly, 3) correlate cell surface protein expression of potential therapeutic targets with each clonal and subclonal population
- ISB 1442 / Glenmark
Initial Dose Escalation of ISB 1442, a Novel CD38 Biparatopic x CD47 Bispecific Antibody, in Patients with Relapsed / Refractory Multiple Myeloma (RRMM) (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6159;
P1/2
The observed clinical CRS events were moderate and potentially related to macrophage activation following ISB 1442 administration. Updated clinical, biomarker and PK data will be presented for this ongoing study.
- Elrexfio (elranatamab-bcmm) / Pfizer
BCMAxCD3 Bispecific Antibody Elranatamab Is Effective in Patient Myeloma Relapsed after BCMA CAR-T (Halls G-H (San Diego Convention Center)) - Nov 3, 2023 - Abstract #ASH2023ASH_6135;
The results suggest that most cases of bispecific antibody resistance are due to T cell health or number, rather than low BCMA expression. This supports BCMA-targeted re-treatment in patients with adequate T cell health.
- Impact of Gamma-Secretase Inhibition on the Multiple Myeloma Immune Microenvironment (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6134;
This supports BCMA-targeted re-treatment in patients with adequate T cell health. In a phase I, first-in-human clinical trial (n=18; relapsed/refractory MM) combining the GSI, crenigacestat, with anti-BCMA CAR T-cell therapy (FCARH143), we recently demonstrated that plasma cell BCMA antibody-binding capacity increased a median of 12-fold among 17/18 (94%) of participants after they received a 5-day GSI
- Expression of Cell Surface Immunotherapy Targets across the Multiple Myeloma Disease Spectrum: Implications for Sequencing and Multi-Target Strategies (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6129;
Expression levels of targets may be one of many factors involved in progression after administration of immunotherapy that may be of variable importance depending on the target, and timing and nature of therapy employed. KHS & FLL contributed equally
- Sarclisa (isatuximab-irfc) / Sanofi
A Phase II Study of Isatuximab, Once Weekly Carfilzomib, Lenalidomide, Dexamethasone, in Newly Diagnosed, Transplant-Eligible Multiple Myeloma (The SKylaRk Trial) (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6122;
P2
Isa-KRd induces deep and durable responses, with an ORR of 100% (including 96% VGPR or better, 66% MRD negative) as well as improved quality of life in transplant-eligible patients with NDMM, with or without SCT. The overall safety profile was favorable and consistent with similar regimens in this setting, with toxicities proving generally manageable.
- iberdomide (CC-220) / BMS
RRMM and Post-BCMA Treated Subjects from the CC-220-MM-001 Study Show Increased Genomic Aberrations Associated with High-Risk and Significant Dysfunction in CD4+ T-Cell Compartment Compared ... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6116;
P1b/2a
Conclusions These data illustrate that late-line RRMM subjects have appreciable immunosuppression compared to NDMM subjects, with particular dysfunction in the CD4+ helper T-cell compartment, suggesting that the efficacy of immunotherapies in late line myeloma may benefit from combinations with agents that improve CD4+ T-cell function. These data also show enrichment of molecular high-risk segments and CRBN-related genomic aberrations in RRMM subjects in the CC-220-MM-001 study.
- SAR442257 / Sanofi
The CD38/CD3xCD28 Trispecific Antibody (SAR442257) Potentially Represents a Novel Therapeutic Strategy for Peripheral T-Cell Lymphomas (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_5823;
SAR 442257 also induced CD25 and CD69 expression on normal T-cells suggesting efficient T-cell activation, (data not shown). Conclusion Altogether, this study shows that 1) most PTCL cells express at least CD28 or CD38, and 2) SAR 442257 can efficiently kill malignant PTCL cells, while ensuring effective T-cell activation; In view of these results, clinical investigation of SAR442257 in PTCL is warranted.
- Talvey (talquetamab) / J&J
Talquetamab + Pomalidomide in Patients with Relapsed/Refractory Multiple Myeloma: Safety and Preliminary Efficacy Results from the Phase 1b MonumenTAL-2 Study (Seaport Ballroom ABCD (Manchester Grand Hyatt San Diego)) - Nov 3, 2023 - Abstract #ASH2023ASH_5196;
P1, P2
The safety profile of the combination, including grade 3/4 hematologic toxicity, was consistent with the individual agents, with no evidence of additive hematologic toxicities; additionally, there were low rates of treatment discontinuation due to AEs. The promising efficacy and manageable safety profile of this combination further supports tal as a versatile combination partner and warrants further evaluation of this regimen.
- Talvey (talquetamab) / J&J
Efficacy and Safety of Less Frequent/Lower Intensity Dosing of Talquetamab in Patients with Relapsed/Refractory Multiple Myeloma: Results from the Phase 1/2 MonumenTAL-1 Study (Grand Hyatt - Seaport Ballroom ABCD) - Nov 3, 2023 - Abstract #ASH2023ASH_5192;
P1, P2
GPRC5D-associated TEAEs generally improved over time in the prospectively design cohorts. Overall, reduced or less frequent tal dosing may help to mitigate these TEAEs while maintaining response.
- WU CART 007 / Wugen
Phase 1/2 Dose-Escalation/Dose-Expansion Study of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Relapsed or Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma (T... (SDCC - Room 6CF) - Nov 3, 2023 - Abstract #ASH2023ASH_4897;
P1/2
Two different LDC regimens have been tested: standard LDC (fludarabine 30 mg/m 2 /day x 3 days and cyclophosphamide 500 mg/m 2 /day x 3 days), and enhanced LDC (eLDC; fludarabine 30 mg/m2/day x 4 days and cyclophosphamide 1000 mg/m2/day x 3 days)...Most (72%; 13/18) pts had G1-2 CRS events; a single G3 CRS event was reported which resolved within 72 hours after receiving tocilizumab, dexamethasone, and low-dose vasopressors...This program advances CAR-T cell therapy in heavily pre-treated patients with R/R T-ALL/LBL. Enrollment is ongoing.
- Evaluation of Novel Minimal Screening Antibody Panel for Immunophenotypic Detection of Hematological Malignancies in a Resource-Constrained Setting: A Prospective Study (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4613;
The usefulness of this screening test is limited with dilute sample. However, the present study shows that this screening panel can be used in small resource-constrained and remote settings with a trained flow cytometry technologist alone.
- Actemra IV (tocilizumab) / Roche, JW Pharma, SNC102 / Shanghai Simnova Bio
Phase I Clinical Study of Humanized BCMA-Single-Domain Antibodies-Targeting CAR T (BCMA-CART) in Patients with Relapsed/Refractory Multiple Myeloma (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4434;
P1
However, the present study shows that this screening panel can be used in small resource-constrained and remote settings with a trained flow cytometry technologist alone. After lymphatic preconditioning chemotherapy (program: fludarabine 30mg/m 2 /d and cyclophosphamide 300mg/m 2 /d, -5, -4, -3, for 3 consecutive days), all patients received a single dose of CART-BCMA at 2.5
- Darzalex (daratumumab) / J&J
Composition and Dynamic Evolution of the Bone Marrow Microenvironment in AL Amyloidosis during Daratumumab Based Therapy (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4358;
We identified unique characteristics of the BME in AL amyloidosis and dynamic changes within the T cell compartment following Daratumumab based therapy. Further validations are needed to evaluate the potential of BME profiling to diagnose the disease, predict treatment response and potentially develop new therapeutic strategies in AL Amyloidosis.
- Blenrep (belantamab mafodotin-blmf) / GSK
High Responses Rates with Single Agent Belantamab Mafodotin in Relapsed Systemic AL Amyloidosis (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4350;
Belantamab mafadotin has high efficacy and good tolerability in multiply relapsed AL amyloidosis including efficacy in patients otherwise excluded from clinical trials. Treatment-emergent adverse events (especially keratopathy) do not preclude delivery of drug with appropriate dose reductions.
- ISB 2001 / Glenmark
A Phase 1, First-in-Human, Dose Escalation and Dose-Expansion Study of a BCMAxCD38xCD3 Targeting Trispecific Antibody ISB 2001 in Subjects with Relapsed/Refractory Multiple Myeloma (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4337;
P1
ISB 2001 has been designed to overcome those resistance mechanisms inherent to current MM therapies such as monoclonal antibodies (e.g. daratumumab), BCMA-targeted therapies, proteasome inhibitors(PIs), or immunomodulatory drugs(IMiDs)...The first-in-human dose was derived by integrating both in vitro and in vivo preclinical data benchmarked to teclistamab utilizing a quantitative systems pharmacology (QSP) model guided approach...A total of approximately 40 evaluable patients will be enrolled in Part 2. The study is currently open for enrollment (Clinicaltrials.gov identifier: NCT05862012).
- Darzalex (daratumumab) / J&J, Darzalex Faspro (daratumumab/hyaluronidase) / J&J
Daratumumab, Bortezomib, Melphalan, and Prednisone (D-VMP) Versus Bortezomib, Melphalan, and Prednisone (VMP) Alone in Transplant-Ineligible Asian Patients with Newly Diagnosed Multiple Myel... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4329;
P3
No new safety concerns were identified for D-VMP with extended follow-up. In addition, daratumumab SC administration was preferred by the majority of patients who switched from daratumumab IV.
- Elrexfio (elranatamab-bcmm) / Pfizer
Long-Term Efficacy and Safety of Elranatamab Monotherapy in the Phase 2 Magnetismm-3 Trial in Relapsed or Refractory Multiple Myeloma (RRMM) (Halls G-H (San Diego Convention Center)) - Nov 3, 2023 - Abstract #ASH2023ASH_4326;
P2
The most common any grade (?25%) and grade 3/4 (?10%) adverse events (any grade, grade 3/4) were infections (69.9%, 40.7%), CRS (57.7%, 0%), anemia (48.8%, 37.4%), neutropenia (48.8%, 48.8%), diarrhea (41.5%, 1.6%) thrombocytopenia (31.7%, 23.6%), lymphopenia (26.8%, 25.2%), fatigue (36.6%, 4.1%), nausea (26.8%, 0%), injection site reaction (26.8%, 0%), hypokalemia (26.0%, 10.6%), cough (26.0%, 0%) pyrexia (30.9%, 4.1%), decreased appetite (33.3%, 0.8%), leukopenia (15.4%, 13.0%) and COVID-19 pneumonia (14.6%, 11.4%). CONCLUSIONS Extended follow-up from the ongoing phase 2 MagnetisMM-3 trial of elranatamab in heavily pretreated participants with RRMM demonstrated sustained clinical efficacy, with median DOR, PFS, and OS not reached, and no new safety signals.
- Talvey (talquetamab) / J&J
Updated Results of Talquetamab, a GPRC5D (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4318;
P1, P2
CONCLUSIONS Extended follow-up from the ongoing phase 2 MagnetisMM-3 trial of elranatamab in heavily pretreated participants with RRMM demonstrated sustained clinical efficacy, with median DOR, PFS, and OS not reached, and no new safety signals. These updated results from pts with prior TCR in the phase 1/2 MonumenTAL-1 study show continued strong efficacy of GPRC5D-targeting talquetamab across populations exposed to TCR (predominantly anti-BCMA), with notable ORR of 73% and mDOR of >1 year in the post
- Tecvayli (teclistamab) / Genmab, J&J
Optec: A Phase 2 Study to Evaluate Outpatient Administration of Teclistamab, a BCMA-Targeting Bispecific Antibody, in Patients with Multiple Myeloma (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4314;
P2
Follow-up of participants during the study will include monitoring for all adverse events, disease progression, and survival until end of study. By studying the feasibility and safety of administering the step-up dosing schedule in an outpatient setting, teclistamab may become more accessible to pts with RRMM and limited treatment options.
- linvoseltamab (REGN5458) / Regeneron, Sanofi
Health-Related Quality of Life (HRQoL) Among Patients with Triple-Class Exposed Relapsed/Refractory Multiple Myeloma (RRMM) Treated with Linvoseltamab in Linker-MM1: Interim Assessment up to 36 Weeks of Treatment (Halls G-H (San Diego Convention Center)) - Nov 3, 2023 - Abstract #ASH2023ASH_4299;
P1/2
Conclusions During 36 weeks of treatment, improvements in measures of HRQoL, including pain, were reported among patients with RRMM receiving linvoseltamab. These PRO findings support a favorable benefit-risk profile of linvoseltamab consistent with clinical results.
- Elrexfio (elranatamab-bcmm) / Pfizer
Efficacy and Safety of Elranatamab in Black Patients with Relapsed/Refractory Multiple Myeloma (RRMM): A Subgroup Analysis of the Magnetismm Studies (Halls G-H (San Diego Convention Center)) - Nov 3, 2023 - Abstract #ASH2023ASH_4273;
P1, P2
Efficacy and safety results are comparable to those observed for the overall population of patients treated with elranatamab in the phase 2 MagnestisMM-3 trial. No new safety signals were observed.
- apitolisib (GDC-0980) / Roche, Farydak (panobinostat) / Secura Bio
Development of Next Generation Antibody-Polymer-Drug Conjugates for Treatment of Multiple Myeloma (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4247;
CD38 upregulation was done by incubating with 10 or 25 nM panobinostat for 24 h and the apoptosis detection employed Annexin V and Propidium Iodide staining followed by flow cytometry analysis...Among them, we firstly prepared Epirubicin (EPI)-based pADCs, such as DARA-P-EPI, ISA-P-EPI and DRO-P-EPI (Fig.1A)...Notably, co-treatment of RPMI8226 cells with anti-CD38 and GDC0980, a PI3k/mTOR inhibitor, significantly improved cytotoxicity, suggesting DARA's potential for chemo sensitization (Fig.1G)... pADC
- Xpovio (selinexor) / Karyopharm, Menarini, FORUS Therap
Selinexor Disrupts Epigenetic Programing and Modulates Immunogenicity in Multiple Myeloma (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4240;
P1/2
Sequential BM biopsies from SELI treated patients demonstrate decreased expression of H3K27me3-regulated genes, suggesting increased EZH2 activity by nuclear accumulation. Finally, SELI-resistant primary cells have increased expression of EZH2 regulated immunotherapy target genes (e.g.
- Darzalex (daratumumab) / J&J, Sarclisa (isatuximab-irfc) / Sanofi
Multiple Myeloma B Cells and Pre-Plasma Cells Are Important Reservoirs for Myeloma Relapse Following Plasma Cell-Directed Therapy and Prevent Cure with Standard Therapies (Grand Hyatt - Harbor Ballroom) - Nov 3, 2023 - Abstract #ASH2023ASH_3327;
We propose that cure of MM requires eradication of MM progenitor cells alongside plasma cells. We are currently conducting scRNA-seq and CITE-seq studies of primary MM samples to further characterize MM progenitor cells for gene and protein expression in order to define their optimal therapeutic targets.
- NXC-201 / Immix Biopharma
Feasibility of a Novel Academic Anti-BCMA Chimeric Antigen Receptor T-Cell (CART) (HBI0101) for the Treatment of Relapsed and Refractory AL Amyloidosis (Grand Hyatt - Seaport Ballroom EFGH) - Nov 3, 2023 - Abstract #ASH2023ASH_3191;
P1
In the largest cohort of AL patients treated with CART reported to date, we demonstrated acceptable toxicity in this frail population, with a remarkable hematologic efficacy, leading to organ responses in most participants. Our data suggests that anti-BCMA CART modality may become a powerful clinical tool to improve organ function and survival, even in advanced AL patients.
- Abecma (idecabtagene vicleucel) / BMS, 2seventy bio
French Early Nationwide Idecabtagene Vicleucel (Ide-Cel) Chimeric Antigen Receptor (CAR) T-Cell Therapy Experience in Patients with Relapsed/Refractory Multiple Myeloma (FENIX): Update of th... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_2575;
Importantly, patients with EMD had a significant lower PFS. Prognosis data at relapse following ide- cel require a longer follow up and will be presented at ASH.
- bortezomib / Generic mfg.
Applying Machine Learning to Support Early Diagnosis of Light-Chain Amyloidosis: A Combination of Knowledge-Based Approach with Data-Driven Approach (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_2470;
There are several available effective treatments including autologous stem cell transplant, bortezomib, anti-CD38 antibodies, and immunomodulatory drugs...This novel ML-based diagnostic model has potential to assist in the earlier diagnosis of AL amyloidosis in clinical settings. Further studies are needed to confirm these findings in different study populations.
- Blenrep (belantamab mafodotin-blmf) / GSK
A Phase I/II Single Arm Study of Belantamab Mafodotin, Carfilzomib and Dexamethasone in Patients with Relapsed Multiple Myeloma: Planned Interim Analysis of Safety and Efficacy. Amarc 19-02 ... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_2443;
The preliminary efficacy data is encouraging with deep responses observed after only 2 cycles of therapy. Recruitment is close to completion with the main analysis to be conducted once all pts have completed the 12-month assessment.
- Actemra IV (tocilizumab) / Roche, JW Pharma, Tecvayli (teclistamab) / Genmab, J&J
Prophylactic Tocilizumab to Prevent Cytokine Release Syndrome (CRS) with Teclistamab Administration (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_2439;
Prophylactic tocilizumab prevented usage of steroids, prevented dose delays, prevented readmission to the hospital, and possibly reduced the occurrence of ICANS. These data make a case for early incorporation of prophylactic tocilizumab and support outpatient administration of teclistamab in most patients.
- Talvey (talquetamab) / J&J
Clinical Outcomes of Subsequent Therapies in Patients with Relapsed/Refractory Multiple Myeloma Following Talquetamab Treatment: Analyses from the Phase 1/2 MonumenTAL-1 Study (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_2438;
P1, P2
Subsequent treatment with T-cell redirection therapies appears feasible, with 25.0% of pts achieving a complete response or better with CAR-T therapy post tal. Further investigation in larger pt populations is warranted to better understand the sequencing of T-cell redirecting therapies after tal to optimize outcomes.
- Darzalex (daratumumab) / J&J
Subgroup Analyses of Progression-Free Survival from the Phase 3 Octans and Alcyone Studies in Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma Treated with Bortezomib, Me... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_2437;
P3
In addition, the rates of MRD negativity and sustained MRD negativity were higher with D-VMP vs VMP, and achievement of these deep responses translated into longer PFS, consistent with a prior pooled analysis of the MAIA and ALCYONE studies. These results further support the use of daratumumab in combination with VMP in both Asian and global patients with TIE NDMM.
- Sarclisa (isatuximab-irfc) / Sanofi
The Impact of Isatuximab Regimens on Hypogammaglobulinemia Occurrence, Recovery, and Associated Infections in Patients with Relapsed/Refractory Multiple Myeloma (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_2410;
Among pts treated with Isa monotherapy, there is an early drop in non-involved IgA levels, followed by stabilization. In ICARIA-MM and IKEMA, HGG did not contribute to increased Grade =3 infections.
- MCARH109 - Eureka Therap, BMS, Memorial Sloan / Kettering Cancer Center, Sanofi
Genetic Basis of Relapse after GPRC5D-Targeted CAR T Cells (Grand Hyatt - Seaport Ballroom EFGH) - Nov 3, 2023 - Abstract #ASH2023ASH_1388;
Our patients with heavily pretreated multiple myeloma may harbor greater tumor heterogeneity and genomic instability than previously described, which can facilitate clonal outgrowth of antigen-negative tumor cells under continuous selective pressure of GPRCRD-targeted CAR T cells. Potential strategies to mitigate antigen escape-mediated relapse in myeloma patients receiving T-cell engaging therapies including earlier use of these therapies, multi-antigen targeting, or combination approaches are being evaluated in ongoing trials.
- High-Throughput Plasma Proteomics to Define the Precursor Multiple Myeloma Proteome and Identify Candidate High-Risk Disease Biomarkers of Progression (Grand Hyatt - Seaport Ballroom EFGH) - Nov 3, 2023 - Abstract #ASH2023ASH_1386;
Conclusion We performed the most comprehensive plasma proteomics study to date, which characterized disease stage proteomes and identified candidate high-risk disease biomarkers in longitudinal progressor samples. Further advancements are underway to validate the accuracy levels of the novel candidates, test the performance of a classification model that recognizes disease stage-specific proteins, and determine how best to integrate proteins into current MM risk stratification models.
- Darzalex (daratumumab) / J&J, Darzalex Faspro (daratumumab/hyaluronidase) / J&J
Efficacy and Safety of Daratumumab (DARA) Monotherapy in Patients with Intermediate-Risk or High-Risk Smoldering Multiple Myeloma (SMM): Final Analysis of the Phase 2 Centaurus Study (Grand Hyatt - Harbor Ballroom) - Nov 3, 2023 - Abstract #ASH2023ASH_1232;
P2
A high proportion (44%) of pts in the Intense and Intermediate arms completed 20 cycles and remained on DARA monotherapy per investigator discretion, with a median duration of additional treatment of 46.0 months (~4 years) in the Extension phase. No new safety concerns were observed with extended follow-up.
- Single-cell transcriptome analysis and assembly of immunoglobulins with Oxford Nanopore sequencing after MMR vaccination (251D, Upper Concourse) - Nov 2, 2023 - Abstract #AMP2023AMP_762;
By sequencing patient cells to generate consensus antibodies during an active immune response to viral pathogens, monoclonal antibodies can be synthesized and tested for efficacy. In addition, monoclonal antibodies direct from patient cells may be useful for the development of cancer immunotherapies.
- | Journal: Optimization of treatment strategy for relapsed or refractory multiple myeloma (Pubmed Central) - Oct 29, 2023
Since it is challenging to identify the optimal sequences, it is important to apply each treatment individually based on clinical trial results. In the educational session, the framework to choose the most optimal treatment based on evidence of relapsed multiple myeloma therapies in each treatment line will be discussed.
- | Darzalex (daratumumab) / J&J
Journal, IO biomarker: CD38 Antibody Re-treatment in Daratumumab-Refractory Multiple Myeloma After Time on Other Therapies. (Pubmed Central) - Oct 26, 2023
Patients clinically re-treated with anti-CD38 antibodies had < 6 months of clinical benefit, but one patient for who was daratumumab-exposed but not refractory achieved complete response lasting 13 months. We conclude that transient efficacy can be achieved by waiting one year before CD38 antibody re-challenge, but this approach may be best used as a bridge to, or after, CAR-T.
- || Darzalex (daratumumab) / J&J
Review, Journal: Research Progress and Application of Daratumumab in Non-Multiple Myeloma--Review (Pubmed Central) - Oct 22, 2023
Meanwhile, CD38 is also expressed in other cells, including regulatory T cells, regulatory B cells and myeloid-derived suppressor cells, which provides a theoretical basis for the treatment of hematological tumor diseases other than non-multiple myeloma diseases. This article reviews the research progress and application of this part.
- | Launch US, Journal: Launch and Post-Launch Prices of Injectable Cancer Drugs in the US: Clinical Benefit, Innovation, Epidemiology, and Competition. (Pubmed Central) - Oct 19, 2023
In particular, patients with rare diseases experience greater price increases for their orphan drugs. There is no evidence that brand-brand competition results in drug price reductions.
- Nanobody?based CD38?specific antibody recruiting molecules: Harnessing polyclonal antibodies for cytotoxicity against myeloma cells () - Oct 15, 2023 - Abstract #ESGCT2023ESGCT_796;
Both ARMs mediate complement?dependent cytotoxicity against human multiple myeloma cells in vitro. Our results demonstrate the potential of nanobody?based CD38?specific ARMs to engage immune effector functions for the killing of myeloma cells.
- | Journal: Quad-class exposed/refractory myeloma is associated with short survival. (Pubmed Central) - Oct 14, 2023
PFS was 4.4?months (95% CI?=?2.4-12.5) and OS 6.3?months (95% CI?=?3.9-14.4). Having an adverse prognosis, QCE myeloma patients remain an unmet medical need.
- Sarclisa (isatuximab-irfc) / Sanofi
Real-world Experience with Isatuximab in Patients with Relapsed and/or Refractory Multiple Myeloma (RRMM): IONA-MM First Interim Analysis (Hall E) - Sep 30, 2023 - Abstract #DGHO2023DGHO_1524;
P=N/A
Reused with permission. This abstract was accepted and previously presented at the 2022 IMS Annual Meeting.
- Elrexfio (elranatamab) / Pfizer, Darzalex (daratumumab) / J&J
MagnetisMM-6: An open-label, multicenter, randomized phase 3 study of elranatamab + daratumumab + lenalidomide (EDR) versus daratumumab + lenalidomide + dexamethasone (DRd) in transplant ineligible (TI) patients with newly diagnosed multiple myeloma (NDMM) (Hall E) - Sep 30, 2023 - Abstract #DGHO2023DGHO_1520;
P2, P3
This abstract was accepted and previously presented at the 2022 IMS Annual Meeting. Key exclusion criteria: smoldering MM; monoclonal gammopathy of undetermined significance (MGUS); Waldenstr
- Tecvayli (teclistamab) / Genmab, J&J
BCMA x CD3 Bispecific Antibody Treatment with Teclistamab in Relapsed and/or Refractory Multiple Myeloma: A Real-World Monocentric Analysis (Hall E) - Sep 30, 2023 - Abstract #DGHO2023DGHO_1513;
It yielded promising efficacy with an ORR of 44% and a median PFS of 73d in a heavily pretreated and highly refractory patient cohort. Despite adequate prophylactic measures, significant toxicity was observed with a high rate of severe infections.
- Tecvayli (teclistamab) / Genmab, J&J
Long-Term Follow-Up From MajesTEC-1 of Teclistamab, a B-cell Maturation Antigen (BCMA) x CD3 Bispecific Antibody, in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) (Hall G) - Sep 30, 2023 - Abstract #DGHO2023DGHO_1240;
P1, P2
Despite adequate prophylactic measures, significant toxicity was observed with a high rate of severe infections. Pts had a median of 5 prior LOT (range, 2
- Darzalex (daratumumab) / J&J, Talvey (talquetamab) / J&J
Pharmacodynamic results with talquetamab and daratumumab in patients with relapsed/refractory multiple myeloma in TRIMM-2 (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_1023;
P1b
Conclusions The pharmacodynamic profile of talquetamab + daratumumab was consistent with the respective MOAs and showed induction of T-cell activation, an increase in T-cell clonality, and reduction of immunosuppressive CD38+ Tregs. These data support the promising efficacy of this off-the-shelf immunotherapy combination in patients with RRMM.