Tecvayli (teclistamab-cqyv) News

«1 234 5 6 7 8 9 10 11 12 13...17 18 »

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
Journal: Safety and efficacy of teclistamab in systemic immunoglobulin light chain amyloidosis. (Pubmed Central) - Nov 28, 2023
No abstract available

||||||||||  Tecvayli (teclistamab-cqyv) / Genmab, J&J
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy:  GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5 (clinicaltrials.gov) -  Nov 28, 2023
P2, N=70, Recruiting,  Sponsor: University of Heidelberg Medical Center
No abstract available N=50 --> 70 | Trial completion date: May 2027 --> Oct 2027 | Trial primary completion date: May 2026 --> Oct 2026

|||||||||| Immune and Genome Profiling of Myeloma Patients Treated with Sequential Immunotherapies Reveal Differential Non-Overlapping Mechanisms of Resistance ((Virtual Program)) - Nov 27, 2023 - Abstract #ASH2023ASH_6989;
Patient 3 received 3 sequential therapies with Ide-cel (DOR = 3 mos), teclistamab (DOR = 6 mos), and then talquetamab with daratumumab with an ongoing response of 11 mos...Patient 5 with penta-refractory disease and high disease burden (> 90% BM infiltration) had no response to elranatamab, however achieved an ongoing sCR (DOR = 30 mos) with talquetamab, daratumumab and pomalidomide (Tal-DP)...Therefore, TCE resistance derived from BCMA mutations does not preclude retreatment with another anti-BCMA TCE or CAR T. We here describe variable non-overlapping mechanisms mediating resistance to sequential TCE and CAR T therapies. Dynamic surveillance for antigenic escape and functional evaluation of T cell fitness will optimize immunotherapy sequencing.

|||||||||| Review, Journal: Novel Immunotherapies and Combinations: The Future Landscape of Multiple Myeloma Treatment. (Pubmed Central) - Nov 25, 2023
In multiple myeloma impressive outcomes have improved with the introduction of new therapeutic approaches, mainly those including naked monoclonal antibodies such as daratumumab and isatuximab...Nevertheless, several issues regarding their use are unsolved, such as how to select patients for each strategy or how to sequence these therapies within the MM therapeutic landscape. Here we provide an overview of the most recent data about approved conjugated monoclonal antibody belantamab, mafodotin, bispecific antibody teclistamab, and other promising compounds under development, mainly focusing on the ongoing clinical trials with monoclonal antibody combination approaches in advanced and earlier phases of MM treatment.

||||||||||  Tecvayli (teclistamab) / Genmab, J&J, Talvey (talquetamab) / J&J
Phase classification:  RedirecTT-1: A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) -  Nov 22, 2023
P1/2, N=164, Recruiting,  Sponsor: Janssen Research & Development, LLC
Here we provide an overview of the most recent data about approved conjugated monoclonal antibody belantamab, mafodotin, bispecific antibody teclistamab, and other promising compounds under development, mainly focusing on the ongoing clinical trials with monoclonal antibody combination approaches in advanced and earlier phases of MM treatment. Phase classification: P1b/2 --> P1/2

|||||||||| Review, Journal: Immunotherapy of Multiple Myeloma: Current Status as Prologue to the Future. (Pubmed Central) - Nov 18, 2023
This has been driven largely by the introduction of new classes of small molecules, such as proteasome blockers (e.g., bortezomib) and immunomodulators (e.g., lenalidomide), as well as by immunotherapeutic agents starting with the anti-CD38 monoclonal antibody daratumumab in 2015...These include the bispecifics teclistamab, talquetamab, and elranatamab, and the chimeric antigen receptor (CAR) T-cell products idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel)...Included in the discussion are additional monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), bi- and multitargeted mAbs, and CAR T-cells and emerging natural killer (NK) cells, including products intended for "off-the-shelf" (allogeneic) applications. Emphasis is placed on the benefits of each along with the challenges that need to be surmounted if MM is to be cured.

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
Journal: Incidence, timing, and management of infections in patients receiving teclistamab for the treatment of relapsed/refractory multiple myeloma in the MajesTEC-1 study. (Pubmed Central) - Nov 14, 2023
P1, P2
Based on the infection profile of B-cell maturation antigen-targeted bispecific antibodies such as teclistamab, it is recommended that clinicians and patients remain vigilant for a range of infection types throughout treatment to facilitate prompt intervention. Appropriate screening, prophylaxis, and management of infections, hypogammaglobulinemia, and neutropenia are important.

||||||||||  Tecvayli (teclistamab-cqyv) / Genmab, J&J, Darzalex Faspro (daratumumab/hyaluronidase) / J&J, Talvey (talquetamab-tgvs) / J&J
Enrollment open, Trial completion date, Trial primary completion date, Combination therapy, Immuno-oncology:  Teclistamab or Talquetamab in Combination With Daratumumab for High-Risk Smoldering Myeloma (REVIVE Study) (clinicaltrials.gov) -  Nov 13, 2023
P2, N=50, Recruiting,  Sponsor: University of Miami
Appropriate screening, prophylaxis, and management of infections, hypogammaglobulinemia, and neutropenia are important. Not yet recruiting --> Recruiting | Trial completion date: Aug 2029 --> Dec 2029 | Trial primary completion date: Aug 2028 --> Dec 2028

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
Journal: Safe and successful teclistamab treatment in very elderly multiple myeloma (MM) patients: a case report and experience from a total of three octogenarians. (Pubmed Central) - Nov 13, 2023
Not yet recruiting --> Recruiting | Trial completion date: Aug 2029 --> Dec 2029 | Trial primary completion date: Aug 2028 --> Dec 2028 No abstract available

||||||||||  Tecvayli (teclistamab-cqyv) / Genmab, J&J
Trial completion date:  MajesTEC-1: A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) -  Nov 9, 2023
P2, N=194, Active, not recruiting,  Sponsor: Janssen Research & Development, LLC
No abstract available Trial completion date: May 2025 --> Sep 2025

|||||||||| Elrexfio (elranatamab-bcmm) / Pfizer, Tecvayli (teclistamab) / Genmab, J&J, Talvey (talquetamab) / J&J
FDA event, Journal: An Embarrassment of Riches: Three FDA-Approved Bispecific Antibodies for Relapsed Refractory Multiple Myeloma. (Pubmed Central) - Nov 3, 2023
In the past year, three new bispecific antibodies have received accelerated FDA approval for the treatment of relapsed/refractory multiple myeloma. In this article, we review the available data for these three agents, teclistamab, elranatamab, and talquetamab, and discuss practical considerations for their use in clinical settings while the medical community awaits randomized phase III clinical trial datasets comparing them to standard-of-care regimens.

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
Real-World Treatment Outcomes of Teclistamab Under an Outpatient Model for Step-up Dosing Administration (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6625;
Conclusion This study evaluated early RW safety outcomes of teclistamab under an outpatient administration model and found the CRS rate and severity to be comparable with other RW evidence generated from various data sources. Outcomes related to teclistamab SUD from Mayo Clinic supported the safety and feasibility of outpatient administration model as a potential option to reduce healthcare resource utilization and improve treatment experiences.

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
Evolving Real-World Characteristics and Step-up Dosing Among Early Initiators of Teclistamab for Multiple Myeloma (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6556;
Like prior reports, early initiators of this first-in-class bispecific represented a diverse and elderly population with substantial comorbidities; yet, across the index time-based cohorts, the average comorbidity index score fell. Teclistamab SUD was generally administered through a single hospitalization, which may reflect logistical considerations with adverse event monitoring and elective hospital readmissions.

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
Teclistamab Demonstrates Clinical Activity in Real-World Patients Ineligible for the Pivotal Majestec-1 Trial (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6193;
In the BCMA-naive population ORR were similar to MajesTEC-1, but were lower in the previously BCMA-exposed population. High-risk cytogenetics and EMD remain adverse prognostic features with Tec despite similar ORR.

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
Teclistamab in Relapsed Refractory Multiple Myeloma Patients on Dialysis: A French Experience (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6191;
Conclusion These first results suggest that teclistamab is a feasible, effective and safe option for patients with RRMM who need dialysis. These data are very important for such subgroup of patients typically excluded from clinical trials and for CAR T cell therapies that usually requires fludarabine-based lymphodepletion.

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
Prospective Molecular Characterization of Multiple Myeloma Patient Samples Identifies High-Risk Patients and Informs Treatment Sequences through Resistance Mechanisms to Immunotherapies (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6190;
This sample came from a patient who relapsed after an initial response to a BCMA CAR-T, followed by a progression occurring quickly while on a BCMA bispecific antibody Teclistamab, suggesting the loss of BCMA expression as a mechanism of resistance in both treatments...Conclusions. DNA sequencing approaches are cost-effective alternatives to FISH, the current standard diagnostic technology, to detect genomic abnormalities in multiple myeloma and they can identify clinically meaningful markers related to prognosis and treatment, particularly in the emerging era of immunotherapeutics where antigen evasion is a key mechanism of molecular resistance.

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
French Monocentric Experience of Outpatient Step-up Dosing of Teclistamab in Relapsed Refractory Multiple Myeloma (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6188;
Conclusion Outpatient teclistamab step-up dose is feasible with careful patient selection and close at home monitoring, and seems associated with similar safety profiles and efficacy outcomes as inpatient treatment. Outpatient management is cost-effective and may help optimize healthcare resource utilization.

|||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma, Tecvayli (teclistamab) / Genmab, J&J
Tocilizumab Prophylaxis for Patients Treated with Teclistamab: A Single-Center Experience (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6161;
Our findings suggest that tocilizumab may be effective as a preventative, rather than reactive, measure for patients treated with teclistamab. Larger studies are needed to confirm and expand on our results.

|||||||||| Blenrep (belantamab mafodotin-blmf) / GSK
Infection Risk and Use of Prophylaxis with Anti-BCMA Bispecific T Cell Engagers and Belantamab Mafodotin for Patients with Relapsed and Refractory Multiple Myeloma (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6154;
Teclistamab and Belantamab Mafodotin (Belamaf) are currently approved for RRMM in Europe with several Bispecific T Cell Engagers (TCE) under investigation...All patients received aciclovir prophylaxis, PJP prophylaxis (co-trimoxazole/ azithromycin) was given in 100% with TCE and 82% with Belamaf, with anti-fungal prophylaxis in 1 TCE patient...IVIg use was substantially higher for TCE than Belamaf. Blood viral PCR monitoring for TCE patients only detected symptomatic reactivations in 2 out of 13 patients suggesting this was an infrequent event.

|||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma, Tecvayli (teclistamab) / Genmab, J&J
Model-Based Exploration of the Impact of Prophylactic Tocilizumab on IL-6 Dynamics in Multiple Myeloma Patients Receiving Teclistamab Treatment (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6121;
P1, P2
The modeling and simulation results showed that a single dose of tocilizumab given prophylactically at 8 mg/kg could block IL-6R RO for approximately 10 days following the 1 st step up dose of teclistamab. The results further support this approach for lowering overall risk of CRS during the SUD schedule in multiple myeloma patients treated with teclistamab.

|||||||||| Elrexfio (elranatamab-bcmm) / Pfizer, Tecvayli (teclistamab) / Genmab, J&J, Talvey (talquetamab) / J&J
Cumulative Incidence and Characteristics of Infections Requiring Treatment, Delay in Treatment Administration or Hospitalisation in Patients with Relapsed or Refractory Multiple Myeloma Treated with Anti BCMA or Anti GPRC5D Bispecific Antibodies (Seaport Ballroom EFGH (Manchester Grand Hyatt San Diego)) - Nov 3, 2023 - Abstract #ASH2023ASH_5186;
The results further support this approach for lowering overall risk of CRS during the SUD schedule in multiple myeloma patients treated with teclistamab. Among the 229 patients included, 200 (87%) received an anti-BCMA BsAb with teclistamab (n=153,

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
Real-World Patient Profile and Step-up Dosing Process of Early Initiators of Teclistamab for Multiple Myeloma in US Hospitals (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4752;
Additionally, fewer than half of patients in this real-world cohort experienced CRS, as identified using ICD-10-CM codes. Limitations of our analysis include the small sample size, reliance on chargemaster data with inherent limitations (e.g., misclassification and coding errors), and the estimation of CRS incidence and management using diagnosis codes.

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
Identifying Causes of Unscheduled Healthcare Interactions and Changes to Patient Disposition in Individuals Receiving Outpatient Commercial Bispecific Antibody Therapy in Relapsed/Refractory... (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4664;
The high prevalence of URIs in our population indicates that infection rates in this frequently hypogammaglobulinemic patient population may be underreported. However, these do not frequently lead to inpatient admissions or to significant morbidity/mortality.

|||||||||| 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).

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
A Phase 2, Single-Arm, Non-Inferiority Study of Limited-Duration Teclistamab for Relapsed and Refractory Multiple Myeloma (LimiTec) (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4335;
This single-arm, phase 2 study is exploring whether limited-duration teclistamab is non-inferior to continuously administered therapy in patients who have received 6 to 9 months of teclistamab and have achieved at least a very good partial response. Accrual started in July 2023.

|||||||||| 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.

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
Teclistamab Induces Favorable Responses in Patients with Relapsed and Refractory Multiple Myeloma after Prior BCMA-Directed Therapy (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4291;
No new safety signals were identified. Results on progression free survival (PFS) and overall survival (OS) will be reported with continued follow up and will be presented in the meeting.

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
Real-World Evaluation of Teclistamab for the Treatment of Relapsed/Refractory Multiple Myeloma (RRMM) (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4287;
Responses were rapid and are expected to deepen over time (median f/u 5m). CRS rates were similar to MajesTEC-1 and no new toxicity signal was noted.

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
Toxicity and Efficacy Outcomes of Teclistamab in Patients with Relapsed-Refractory Multiple Myeloma (RRMM) Above the Age of 70 Years: A Multicenter Study (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4270;
Based on our results, older age (>70 years) does not appear to affect response outcomes or PFS. For the most part, the safety profile appears similar, however patients older than 70 years were more likely to develop grade 3-4 thrombocytopenia.

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
Real-World Analysis of Teclistamab in 115 RRMM Patients from Germany (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4269;
35.6% (41/115) had received BCMA-directed pretreatment, among them 20 with ide-cel, 21 with belantamab mafodotin and single patients with both or a BCMA-directed study medication...Tocilizumab was administered in 25.2% and dexamethasone in 15.7% of patients...Conclusions With an ORR of 56.8% in all patients and 60.0% in anti-BCMA naive patients, Teclistamab showed a similar ORR in the real-world setting to that observed in the MAJESTEC-1 trial. PFS was slightly lower, but our patient collective comprised higher proportions of patients with high risk disease, extramedullary disease, high disease burden, hematopoietic or renal impairment.

|||||||||| Abecma (idecabtagene vicleucel) / BMS, 2seventy bio, Tecvayli (teclistamab) / Genmab, J&J, Carvykti (ciltacabtagene autoleucel) / J&J
The GLAMM1 Study - Global Access to Myeloma Medications: Potential Barriers to Chimeric Antigen Receptors (CART) and T-Cell-Engaging Bispecific Antibodies (TCE) Globally (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_4267;
More recently in 2022, the first BCMA-directed T-cell-engager (TCE), teclistamab (tec), was also approved for the treatment of relapsed/ refractory multiple myeloma (RRMM)...The main barrier to both CART and TCE is reported as financial burden for patients. USMIRC in collaboration with oncologists worldwide, global agencies, governments, regulatory agencies, policymakers and industry partners, is planning to further explore restrictions to access to CART and TCE and strategies to overcome these barriers.

|||||||||| 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.

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
Teclistamab in Relapsed Refractory Multiple Myeloma: Multi-Institutional Real-World Study (Marriott Marquis - Marriott Grand) - Nov 3, 2023 - Abstract #ASH2023ASH_3199;
The median age was 68 years (range: 37-89), with 48% (n=43) females. Among the patients, 30% (n=27) were Black, 2.2% (n=2) Asian and 12% (n=11) were other minorities.

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
Longitudinal Correlative Profiles of Responders, Nonresponders, and Those with Relapse on Treatment with Teclistamab in the Phase 1/2 MajesTEC-1 Study of Patients with Relapsed/Refractory Mu... (Grand Hyatt - Harbor Ballroom) - Nov 3, 2023 - Abstract #ASH2023ASH_3073;
P1, P2
In contrast, an exhausted T-cell phenotype was sustained in nonresponders during the first 2 treatment cycles. While mutations in BCMA cannot be excluded, we did not detect BCMA loss as a mechanism of relapse, but observed a dysfunctional immune phenotype at PD, with increased T-cell exhaustion and higher frequency of gamma delta T cells and immunosuppressive Tregs.

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
Single Cell Multi-Omic Dissection of Response and Resistance to Chimeric Antigen Receptor T Cells Against BCMA in Relapsed Multiple Myeloma (Grand Hyatt - Harbor Ballroom) - Nov 3, 2023 - Abstract #ASH2023ASH_3071;
The prior administration of the bispecific antibody teclistamab had no significant impact on the quantitative cellular composition at the time of leukapheresis...Successful CAR T cell manufacturing is hampered by exposure to bispecific antibodies but can be successfully achieved by allowing for a wash-out phase of ca. 4 weeks.

|||||||||| Tecvayli (teclistamab) / Genmab, J&J, Carvykti (ciltacabtagene autoleucel) / J&J
Patient Awareness of CAR-T and Bispecific Antibody Treatments for Multiple Myeloma: Real-World Learnings and Disparities (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_2867;
T ime since diagnosis was <5 years in 59.5%. Majority of the respondents (89.4%) were non-Hispanic Whites (NHW) .

|||||||||| Darzalex (daratumumab) / J&J, Tecvayli (teclistamab) / Genmab, J&J
Ex Vivo Mathematical Myeloma Advisor (EMMA) (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_2724;
Through the testing of standard-of-care drugs alongside immune agents, our pipeline has identified the combination of bortezomib + daratumumab as a synergistic approach with significant translational potential, warranting further investigation...The advantages offered by our system are threefold: i) it enables pharmaceutical companies to test new compounds in a bona fide , patient-derived model; ii) it assists clinicians in selecting the best therapy for their patients, and iii) it helps prevent cancer patients from receiving non-suitable therapies. This approach can also be promptly applied to other liquid cancers, such as leukemia and lymphoma.

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
Safety and Efficacy of Teclistamab in Patients with Relapsed or Refractory AL Amyloidosis: A Retrospective Case Series (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_2467;
Tec was well-tolerated, with cytokine release syndrome being manageable in this population, though acute kidney injury and treatment-limiting neutropenia did occur. Teclistamab shows promise in treating patients with relapsed AL amyloidosis, but further prospective studies and longer duration of follow-up are needed to determine long-term outcomes and to optimize safety in this at-risk patient population.

|||||||||| Elrexfio (elranatamab-bcmm) / Pfizer, Tecvayli (teclistamab) / Genmab, J&J
A Matching-Adjusted Indirect Comparison of the Efficacy of Elranatamab and Teclistamab in Patients with Triple-Class Exposed/Refractory Multiple Myeloma (Halls G-H (San Diego Convention Center)) - Nov 3, 2023 - Abstract #ASH2023ASH_2446;
P2
CONCLUSIONS In this MAIC, elranatamab demonstrated significantly better ORR and PFS than TEC, and numerically better DOR and OS in both the base case and the sensitivity analysis. These results suggest that elranatamab is an effective option for treating patients with TCE/R MM.

|||||||||| 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.

|||||||||| Tecvayli (teclistamab) / Genmab, J&J, Talvey (talquetamab) / J&J
Efficacy of Bispecific Antibodies Vs CAR-T in the Treatment of Extramedullary Disease and High-Risk Cytogenetics in Relapsed Multiple Myeloma: A Systematic Review and Meta-Analysis (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_2424;
ORR in the whole cohort, EMD cohort, and HRCA cohort were found to be superior with CAR T cell therapy. However, it is difficult to make direct comparisons of pooled estimates of two different therapies.

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
Patterns of Cytokine Release Syndrome with Teclistamab in Relapsed/Refractory Multiple Myeloma with or without Prior T-Cell Redirection Therapy (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_2391;
In our study, prior exposure to a TCRT was associated with a significantly lower incidence of CRS during the Tec step-up dosing phase, which may be suggestive of T-cell exhaustion. This observation will allow for optimization of CRS prophylactic strategies for RRMM patients receiving Tec treatment.

|||||||||| Pooled Analysis on Bispecific Antibody-Related Toxicities in Multiple Myeloma (Halls G-H (San Diego Convention Center)) - Nov 3, 2023 - Abstract #ASH2023ASH_2383;
Our results showed that non-BCMA bsAb were associated less hematotoxicity (combined grade 3-4 events and hypogammaglobulinemia), whereas BCMA bsAb were associated with less CRS rates. This is important information for treatment selection and mitigation strategy development aiming to optimize patient outcomes.

|||||||||| Immune and Genome Profiling of Myeloma Patients Treated with Sequential Immunotherapies Reveal Differential Non-Overlapping Mechanisms of Resistance (Halls G-H (San Diego Convention Center)) - Nov 3, 2023 - Abstract #ASH2023ASH_2374;
Patient 3 received 3 sequential therapies with Ide-cel (DOR = 3 mos), teclistamab (DOR = 6 mos), and then talquetamab with daratumumab with an ongoing response of 11 mos...Patient 5 with penta-refractory disease and high disease burden (> 90% BM infiltration) had no response to elranatamab, however achieved an ongoing sCR (DOR = 30 mos) with talquetamab, daratumumab and pomalidomide (Tal-DP)...Therefore, TCE resistance derived from BCMA mutations does not preclude retreatment with another anti-BCMA TCE or CAR T. We here describe variable non-overlapping mechanisms mediating resistance to sequential TCE and CAR T therapies. Dynamic surveillance for antigenic escape and functional evaluation of T cell fitness will optimize immunotherapy sequencing.

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
Intracytoplasmatic BCMA Point Mutation and Teclistamab Resistance: Genomic Assessment of a Multidrug-Resistant Multiple Myeloma Patient (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_2354;
However, the role of B2M alterations in disease progression and drug resistance needs to be elucidated. Predicting the biological impact based on 3D structural models remains speculative, thus, functional confirmation introducing the BCMA and B2M alterations in cell line models by genetic engineering is pending.

|||||||||| Abecma (idecabtagene vicleucel) / BMS, 2seventy bio, Tecvayli (teclistamab) / Genmab, J&J, Carvykti (ciltacabtagene autoleucel) / J&J
Adverse Effects and Non-Relapse Mortality of BCMA-Directed Immunotherapies : An FDA Adverse Event Reporting System (FAERS) Database Study (SDCC - Room 6B) - Nov 3, 2023 - Abstract #ASH2023ASH_1414;
Non-ICANS neurotoxicity was more pronounced with ide-cel compared to cilta-cel, potentially influenced by the longer follow-up period and wider uptake of ide-cel as it was the first FDA-approved CAR T therapy. We also note a higher NRM with both cilta-cel and teclistamab compared to ide-cel.

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
Evaluating Tumor-Intrinsic and Patient-Specific Mechanisms of Resistance to Teclistamab in Anti-BCMA Exposed and Na (Grand Hyatt - Seaport Ballroom EFGH) - Nov 3, 2023 - Abstract #ASH2023ASH_1385;
PFS reductions among these anti-BCMA exposed patients may be partly due to independent disease associated risk factors. A pre-Tec peripheral blood T-cell population enriched with highly cytotoxic effector T-cells was associated with response to therapy, while suppressive TIGIT + Tregs were associated with nonresponse, suggesting a potential therapeutic role for TIGIT blockade or CD25 + cell depletion to enhance the therapeutic efficacy of bispecific antibodies.

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
Outpatient Management of CAR-T and Teclistamab for Patients with Lymphoma and Multiple Myeloma (Marriott Marquis - Marriott Grand) - Nov 3, 2023 - Abstract #ASH2023ASH_1283;
The rate of second CRS event after management of first CRS with steroid (dexamethasone/ prednisone) was 15% (2/13)... Our data showed that additional advances in outpatient practice, including initial outpatient management of CRS and outpatient administration of Tec step up dosing are feasible, safe and reduce hospital resource utilization.

|||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma, Tecvayli (teclistamab) / Genmab, J&J
Immuno-PRISM: A Randomized Phase II Platform Study of Bispecific Antibodies in High-Risk Smoldering Myeloma (Grand Hyatt - Harbor Ballroom) - Nov 3, 2023 - Abstract #ASH2023ASH_1228;
The median age is 59 years old (range 35-73) with 9 females (47%) and 10 males ( 53%). Sixty-four percent of patients that had evaluable FISH results had high-risk abnormalities as follows: 1q gain (7 pts), t(4;14) 1 patient.

|||||||||| Tecvayli (teclistamab) / Genmab, J&J
Real-World Safety and Efficacy of Teclistamab for Patients with Heavily Pretreated Relapsed-Refractory Multiple Myeloma (Grand Hyatt - Seaport Ballroom ABCD) - Nov 3, 2023 - Abstract #ASH2023ASH_998;
Overall, teclistamab was well tolerated with no major safety concerns, despite worse performance status and cytopenias than the MajestTEC-1 trial population. Moreover, despite the increased incidence of high-risk features, including penta-refractoriness, BDT refractoriness, and presence of EMD in this heavily pre-treated RRMM patient population, early efficacy assessment of teclistamab in a real-world setting was encouraging.



	Diseases Companies Products Productz Mechanisms of Action Sites