ABBV-383 IV / AbbVie 
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  • ||||||||||  ABBV-383 IV / AbbVie
    A Phase 1b Study of Step-up Dosing with ABBV-383, a B-Cell Maturation Antigen (BCMA) x CD3 Bispecific Antibody, in Patients with Relapsed or Refractory Multiple Myeloma (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_5610;    
    P1, P1/2
    Introduction of a modified dexamethasone (Dex) premedication (premed) schedule in cycle (C) 1 lowered incidence and severity of CRS (43% overall; 5% grade ?2) vs pts treated with low Dex (71% overall; 20% grade ?2) (JCO 2024; 42[suppl 16]:7531)...In the DE, 7 (30%) pts experienced CRS; 1 (4%) pt experienced grade 2 CRS, there were no grade ?3 events, and only 2 (9%) pts received tocilizumab to treat CRS...Conclusions Introduction of 1 SUD of 2 mg on D1 followed by full dose of 60 mg on D4 in C1 combined with modification to the Dex premed schedule reduced the incidence and severity of CRS in pts with RRMM, further optimizing the safety profile of ABBV-383. Preliminary efficacy data show early and high response rates, consistent with outcomes from other ABBV-383 studies.
  • ||||||||||  ABBV-383 IV / AbbVie
    Exposure-response analyses for optimal therapeutic dose selection of ABBV-383 in patients with relapsed/refractory multiple myeloma (RRMM). (Hall A; Poster Bd #: 178) -  Apr 24, 2024 - Abstract #ASCO2024ASCO_4067;    
    P1/2, P3
    While ER analyses indicated promising efficacy and acceptable safety profiles for 40, 60 mg Q3W, and 60 mg Q4W, they support 60 mg Q4W as the optimal ABBV-383 therapeutic dose due to its predicted better therapeutic benefit/risk profile (high response rates, improved/equivalent ?G3 neutropenia, and lower CRS events) and extended dosing interval. ABBV-383 at 60 mg Q4W will be investigated in the registrational phase 3 trial (NCT06158841) in RRMM.
  • ||||||||||  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.
  • ||||||||||  MODULE 4: Bispecific Antibodies in the Treatment of MM (Omni San Diego, Grand Ballroom (Level 2), 4) -  Sep 23, 2023 - Abstract #ASH2023ASH_274;    
    Supported by AbbVie Inc, GSK, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Karyopharm Therapeutics, Legend Biotech, Regeneron Pharmaceuticals Inc, and Sanofi. Similarities and differences in the cellular targets and mechanisms of action among bispecific antibodies for MM Antitumor activity observed with teclistamab in the Phase I/II MajesTEC-1 study leading to its recent FDA approval for R/R MM; optimal incorporation into the treatment paradigm Rate, depth and duration of response observed with elranatamab in the pivotal Phase II MagnetisMM-3 trial for patients with R/R MM; FDA approval and current clinical role Key findings with other promising anti-BCMA bispecific antibody constructions, such as alnuctamab, linvoseltamab and ABBV-383, for heavily pretreated MM Available efficacy and safety findings with non-BCMA-targeted bispecific antibodies for MM, such as talquetamab, cevostamab and RG6234; FDA approval of talquetamab for patients with R/R MM after at least 4 prior therapies Spectrum, incidence and severity of cytokine release syndrome and other toxicities with the various BCMA- and non-BCMA-directed bispecific antibodies; optimal mitigation and management strategies Rationale for and early-phase data with bispecific antibodies in combination with other systemic therapies for MM
  • ||||||||||  ABBV-383 / AbbVie
    ABBV-383, a BCMA-CD3 Bispecific Antibody, in Relapsed/Refractory Multiple Myeloma: A Multicenter, Phase 1b Dose Optimization Study With Step-up Dosing (In Person) -  Sep 10, 2023 - Abstract #IMW2023IMW_505;    
    Similarities and differences in the cellular targets and mechanisms of action among bispecific antibodies for MM Antitumor activity observed with teclistamab in the Phase I/II MajesTEC-1 study leading to its recent FDA approval for R/R MM; optimal incorporation into the treatment paradigm Rate, depth and duration of response observed with elranatamab in the pivotal Phase II MagnetisMM-3 trial for patients with R/R MM; FDA approval and current clinical role Key findings with other promising anti-BCMA bispecific antibody constructions, such as alnuctamab, linvoseltamab and ABBV-383, for heavily pretreated MM Available efficacy and safety findings with non-BCMA-targeted bispecific antibodies for MM, such as talquetamab, cevostamab and RG6234; FDA approval of talquetamab for patients with R/R MM after at least 4 prior therapies Spectrum, incidence and severity of cytokine release syndrome and other toxicities with the various BCMA- and non-BCMA-directed bispecific antibodies; optimal mitigation and management strategies Rationale for and early-phase data with bispecific antibodies in combination with other systemic therapies for MM n/a
  • ||||||||||  MODULE 1: Multiple Myeloma (MM) (Hilton Chicago; Grand Ballroom (Level 2)) -  May 26, 2023 - Abstract #ASCO2023ASCO_7060;    
    This activity is supported by educational grants from AbbVie Inc, Genentech, a member of the Roche Group, Genmab US Inc, Karyopharm Therapeutics, Lilly, Regeneron Pharmaceuticals Inc, Sanofi, and Seagen Inc. Clinical and biological factors affecting the selection of up-front therapy for patients with MMLong-term findings with daratumumab-containing regimens for newly diagnosed MM; role for transplant-eligible and ineligible patientsPublished data with novel daratumumab-based quadruplet regimens for transplant-eligible patients with newly diagnosed MMSimilarities and differences between daratumumab and isatuximabKey findings from the Phase III GMMG HD7 trial comparing isatuximab with RVd to RVd alone for transplant-eligible patients with newly diagnosed MMOngoing Phase III studies of isatuximab as a part of induction therapy for transplant-eligible and ineligible patientsAvailable data with and current role of minimal residual disease assessment in therapeutic decision-makingOptimal maintenance approach for transplant-eligible and ineligible patientsResults from Phase III trials evaluating isatuximab-based combination regimens for relapsed/refractory (R/R) MMKey results from the Phase III BOSTON trial leading to the FDA approval of selinexor in combination with bortezomib/dexamethasone for R/R MM; available data with other selinexor-based combinationsStructural makeup and manufacturing of available B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell platformsEfficacy and safety findings from the KarMMa (idecabtagene vicleucel) and CARTITUDE-1 (ciltacabtagene autoleucel) trials for R/R MMAvailable and emerging data with and ongoing studies of BCMA-targeted CAR T-cell therapies in earlier lines of treatmentSimilarities and differences in the cellular targets and mechanisms of action of bispecific antibodies in MMActivity and responses observed with available (teclistamab) and investigational (elranatamab, linvoseltamab, ABBV-383) BCMA-targeted bispecific antibodies in R/R MMBiological rationale for and available data with non-BCMA-targeted bispecific antibodies (eg, talquetamab, cevostamab, forimtamig); FDA breakthrough therapy designation for talquetamabSpectrum, incidence and severity of toxicities, including cytokine release syndrome and neurotoxicity, with bispecific antibodies in patients with MM; mitigation and management protocolsPublished data with and current role of venetoclax-based therapy for patients with MM and t(11;14) or Bcl-2 overexpressionOther promising novel strategies in clinical development for patients with MM
  • ||||||||||  ABBV-383 / AbbVie
    A PHASE 1 FIRST-IN-HUMAN MONOTHERAPY STUDY OF ABBV-383, A BCMA  (Poster area) -  May 12, 2023 - Abstract #EHA2023EHA_1127;    
    P1/2
    CRS was predictable and resolved quickly with standard supportive care. Promising efficacy of ABBV-383 monotherapy was observed, with similar ORR in 40 (58%) and 60mg (61%) cohorts.
  • ||||||||||  ABBV-383 IV / AbbVie
    Enrollment closed, Trial completion date, Trial primary completion date:  TNB383B.0001: A Study of TNB-383B in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) -  Feb 6, 2023   
    P1/2,  N=214, Active, not recruiting, 
    Recruiting --> Active, not recruiting | N=12 --> 8 | Trial completion date: Jan 2025 --> Mar 2024 | Trial primary completion date: Jan 2025 --> Mar 2024 Recruiting --> Active, not recruiting | Trial completion date: Aug 2025 --> May 2026 | Trial primary completion date: Aug 2025 --> May 2026