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  • ||||||||||  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:  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.
  • ||||||||||  Elrexfio (elranatamab-bcmm) / Pfizer, Abecma (idecabtagene vicleucel) / BMS, 2seventy bio
    New P2 trial:  Elranatamab in R/R Multiple Myeloma (clinicaltrials.gov) -  Nov 18, 2023   
    P2,  N=32, Not yet recruiting, 
  • ||||||||||  Abecma (idecabtagene vicleucel) / BMS, 2seventy bio, Carvykti (ciltacabtagene autoleucel) / J&J
    Review, Journal, CAR T-Cell Therapy:  CAR T-cell therapy for multiple myeloma: A clinical practice-oriented review. (Pubmed Central) -  Nov 17, 2023   
    Moreover, many patients continue to exhibit relapse post-treatment, with resistance mechanisms yet to be fully understood. Ongoing basic, translational, and clinical research efforts are poised to generate deeper insights into the optimal utilization of these therapies, improve their efficacy, minimize associated toxicity, and identify new target antigens in MM patients.
  • ||||||||||  Abecma (idecabtagene vicleucel) / BMS, 2seventy bio, Carvykti (ciltacabtagene autoleucel) / J&J
    Reversible Parkinsonism After BCMA-directed CAR T cell Administration (Exhibit Hall A/B) -  Nov 11, 2023 - Abstract #SNO2023SNO_814;    
    B-cell maturation antigen (BCMA)-targeting chimeric antigen receptor (CAR)T cell therapy has revolutionized the treatment of patients with relapsed or refractory multiple myeloma (MM), resulting in FDA-approval of two products, idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel)...Here we describe a patient with MM who developed features of parkinsonism on day 24 post ide-cel infusion which were apparently reversible with supportive care and dexamethasone...To our knowledge, this is the first case report of steroid responsive parkinsonism after BCMA-CAR therapy. Our report supports close neurological monitoring of patients beyond 30 days after BCMA-CAR and suggests that intervening early in the setting of hypokinetic movement disorders may lead to sustained reversal of symptoms.
  • ||||||||||  bb21217 / BMS, 2seventy bio
    Trial completion, Trial completion date, Trial primary completion date, CAR T-Cell Therapy:  CRB-402: Study of bb21217 in Multiple Myeloma (clinicaltrials.gov) -  Nov 7, 2023   
    P1,  N=72, Completed, 
    Our report supports close neurological monitoring of patients beyond 30 days after BCMA-CAR and suggests that intervening early in the setting of hypokinetic movement disorders may lead to sustained reversal of symptoms. Active, not recruiting --> Completed | Trial completion date: Oct 2025 --> Dec 2022 | Trial primary completion date: Oct 2025 --> Dec 2022
  • ||||||||||  Abecma (idecabtagene vicleucel) / BMS, 2seventy bio
    Idecabtagene Vicleucel (ide-cel) Versus Standard (std) Regimens in Patients (pts) with Triple-Class (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_6337;    
    P3
    Prospective validation of our model-based findings through measurement of Flu blood levels, CAR-T PK, and clinical outcomes is warranted. Introduction In the KarMMa-3 trial (NCT03651128), ide-cel, a BCMA-directed CAR T cell therapy (Tx), significantly improved median progression-free survival (13.3 vs 4.4 mo, HR 0.49, P < 0.001) and overall response rate (71% vs 42%, P < 0.001) vs std regimens in pts with RRMM who were TCE to immunomodulatory (IMiD
  • ||||||||||  Abecma (idecabtagene vicleucel) / BMS, 2seventy bio
    A National Platform and Scoring System Allocates CAR-T Treatment Slots for Multiple Myeloma to Patients with High Likelihood of Complete Remission (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_6153;    
    Introduction Therapy of relapsed and refractory multiple myeloma (MM) with Ide-Cel is superior to alternative treatments, but availability is lower than the number of patients in need...The SBST scoring system prospectively reflects differential likelyhood of CR (100>64>53>33%), and the scoring dimensions (ECOG, tumor load, inflammation) prospectively correlate with a CR rate of 57 %, supporting the selection process. The SBST CAR-T scoring system may be used to allocate CAR-T treatment slots to maximize benefit from this treatment.
  • ||||||||||  Abecma (idecabtagene vicleucel) / BMS, 2seventy bio
    Real World Outcomes with Idecabtagene Vicleucel (Ide-Cel) CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma (SDCC - Room 6CF) -  Nov 3, 2023 - Abstract #ASH2023ASH_5212;    
    We observed a favorable safety and efficacy profile in this real-world population, despite a very heavily pre-treated population and large proportion of patients having co-morbidities that would have made them ineligible for the KarMMa clinical trial. These results further support ide-cel as a therapeutic option for a broad, real-world population of patients with RRMM.
  • ||||||||||  Abecma (idecabtagene vicleucel) / BMS, 2seventy bio, Carvykti (ciltacabtagene autoleucel) / J&J
    Outcomes after CAR T Cells in Multiple Myeloma Patients with Extramedullary and Paramedullary Disease (Grand Hyatt - Seaport Ballroom EFGH) -  Nov 3, 2023 - Abstract #ASH2023ASH_5187;    
    In our single-center retrospective analysis, the presence of EMD but not PMD was associated with significantly worse PFS and OS following CAR T-cell therapy. EMD+ patients with SPD <50 cm 2 experienced high response rates and deep responses following CAR T-cell therapy (with two-thirds of patients clearing EMD), while patients with the highest extramedullary tumor burdens (SPD =50 cm 2 ) did not.
  • ||||||||||  Abecma (idecabtagene vicleucel) / BMS, 2seventy bio, Carvykti (ciltacabtagene autoleucel) / J&J
    The Effect of Stem Cell Infusion on Immune Effector Cell Associated Hematotoxicity with BCMA CAR T in Multiple Myeloma (Grand Hyatt - Seaport Ballroom EFGH) -  Nov 3, 2023 - Abstract #ASH2023ASH_4883;    
    The utilization of a stem cell boost for managing ICAHT lead to significantly improved Hgb and platelet counts at 3 and 6 months follow up with also substantial improvement in ANC without further G-CSF requirements. These results suggest that the use of stem cell infusions in CAR-T cell induced ICAHT can improve cytopenia associated morbidities and facilitate further anti MM therapy post CAR-T relapse.
  • ||||||||||  Abecma (idecabtagene vicleucel) / BMS, 2seventy bio, Carvykti (ciltacabtagene autoleucel) / J&J
    Salvage Transplant Versus CAR-T Cell Therapy for Relapsed Multiple Myeloma (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_4543;    
    CAR- T cell therapy appeared to improve outcomes, especially in comparison with salvage autoHCT. The higher absolute rates of non-relapse mortality observed with CAR-T cell therapy may not counterbalance overall beneficial results, and rather highlights the need for careful selection of patients.
  • ||||||||||  Abecma (idecabtagene vicleucel) / BMS, 2seventy bio
    Apheresis for Production of Chimeric Antigen Receptor (CAR) T Cells in Patients with Multiple Myeloma - Clinical Factors, Cell Composition and T Cell Senescence (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_4468;    
    We performed a retrospective analysis of clinical parameters influencing both collection of autologous lymphocytes and the subsequent manufacturing of idecabtagene-vicleucel with a special focus on T cell senescence, defined as loss of CD27 and CD28...In contrast, a successful manufacturing was not influenced by patient age, sex, remission status at apheresis or number of previous treatment lines. Further analyses are required to determine measures appropriate for further optimization of autologous lymphocyte collections and improvement of collection outcomes in patients with MM.
  • ||||||||||  Incidence and Outcomes of Cytomegalovirus Reactivation after Chimeric Antigen Receptor T Cell Therapy (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_4462;    
    CMV reactivation is a common complication of CAR T cell therapy in CMV seropositive individuals. Although confirmatory studies are needed, our data shows that administration of immunosuppression, in particular steroids, for management of CAR T cell toxicities is a major risk factor for CMV reactivation, and close monitoring for preemptive therapy or antiviral prophylaxis might be indicated in this setting.
  • ||||||||||  Abecma (idecabtagene vicleucel) / BMS, 2seventy bio
    Impact of Frailty on Outcomes after CAR T-Cell Therapy for Patients with Relapsed/Refractory Multiple Myeloma (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_4449;    
    While these patients had worse performance status and higher comorbidity burden at the time of CAR T infusion, they did not experience any excessive high-grade toxicities including TRM. When compared to the non-frail group, frail patients had numerically inferior but statistically similar depth and duration of response.
  • ||||||||||  Abecma (idecabtagene vicleucel) / BMS, 2seventy bio, Blenrep (belantamab mafodotin-blmf) / GSK
    CD70 CAR NK Cells in the Treatment of Multiple Myeloma (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_4407;    
    P1/2
    In summary, we were able to demonstrate that CD70 can be a feasible target for the treatment of multiple myeloma, including in patients who have failed BCMA targeted therapy. Based on these results, we have initiated a Phase I/II clinical trial (NCT05092451) that is currently recruiting.
  • ||||||||||  cevostamab (RG6160) / Roche
    Sequential T-Cell Engagement for Myeloma ( (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_4330;    
    P2
    This phase 2 study is exploring the efficacy, safety, and feasibility of cevostamab consolidation following BCMA-directed CAR T cell therapy for RRMM, with the goal of sequential T cell engagement against 2 different antigens to eliminate residual disease. Accrual started in July 2023.
  • ||||||||||  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.
  • ||||||||||  Machine Learning-Based Time-Series Clustering Identifies Archetypal Trajectories of Hematotoxicity after CAR T-Cell Therapy (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_2579;    
    CAR T-cell products were axi-cel, n= 101 (25%); brexu-cel, n = 24 (6%); cilta-cel, n = 21 (5%); liso-cel, n = 46 (11%); ide-cel, n = 25 (6%); tisa-cel, 12 (3%); and investigational CD19 or CD20 CAR T-cell products, n = 174 (43%). A logistic regression model using pre-LD ANC, platelet, Hb, LDH, CRP, and ferritin showed improved discrimination and sensitivity compared to CAR-HEMATOTOX in our training set, but both models had low specificity (poor ability to