etentamig intravenous (ABBV-383 IV) / AbbVie - LARVOL DELTA

Long-term efficacy and safety of etentamig, a B-cell maturation antigen (BCMA) bispecific antibody in patients with relapsed/refractory multiple myeloma (RRMM). (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

Study of Intravenously (IV) Infused Etentamig in Combination With an Oral Cereblon E3 Ligase Modulatory Drug (CELMoD) Agent Assessing Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=135 | Not yet recruiting | Sponsor: TeneoOne Inc.

New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology • Targeted Protein Degradation

A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused Etentamig (ABBV-383) in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=320 | Recruiting | Sponsor: TeneoOne Inc. | Trial completion date: Jul 2031 ➔ Sep 2033 | Trial primary completion date: Nov 2028 ➔ Sep 2033

Adverse events • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Comprehensive Review of Bispecific Antibody Constructs In Multiple Myeloma: Affinities, Dosing Strategies and Future Perspectives. (PubMed, Clin Lymphoma Myeloma Leuk) - "Teclistamab, elranatamab (both BCMA × CD3), and talquetamab (GPRC5D × CD3) are approved for treating MM patients who have received at least 3 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody...As linvoseltamab, alnuctamab, and ABBV-383 (all BCMA × CD3), as well as forimtamig (GPRC5D × CD3) and cevostamab (FcRH5 × CD3) progress through late-stage clinical development, emerging trispecific antibodies are now available that target either 2 different MM-associated antigens or provide additional co-stimulatory signals to prevent T-cell exhaustion. Despite this plethora of therapeutic options, resistance to bsAbs is an inevitability, and the optimal positioning of these drugs within the current MM treatment landscape remains to be determined. In this review, we examine the available data on all clinically accessible bsAbs, evaluating their potential, current limitations, and..."

Journal • Review • Hematological Malignancies • Multiple Myeloma • Oncology

ABBV-383 Plus Daratumumab-Dexamethasone in Relapsed or Refractory Multiple Myeloma: A Phase 1b Dose-Escalation and Safety Expansion Study (ASH 2024) - P1, P1/2 | "Conclusion Preliminary data suggest ABBV-383 in combination with Dd is tolerable. Overall rates of CRS were low and early response rates were promising in the investigated population of heavily pretreated pts with MM."

Clinical • P1 data • Anemia • Fatigue • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Novel Coronavirus Disease • Oncology • Pneumonia • Respiratory Diseases • Thrombocytopenia

Exposure-Response (ER) and Pharmacokinetic/Pharmacodynamic (PK/PD) Analyses for Optimal Step-up Dose (SUD) Selection to Improve Cytokine Release Syndrome (CRS) Safety Profile of Abbv-383 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM) (ASH 2024) - P1, P1/2 | "ABBV-383 monotherapy has shown promising activity and improved CRS safety profile with modified dexamethasone (Dex) premedication in patients (pts) with RRMM (NCT03933735; Rodriguez et al., JCO 2024; 42[suppl 16] : 7531). The CRS PK/PD predictions indicated that implementation of 2-SUDs provide minimal additional or no improvement in CRS safety profile compared to 1-SUD. Overall, the 1-SUD dosing regimen of 2 mg with modified premedication prior to the full dose of 60 mg Q4W showed promising results and can be considered for future evaluation and studies."

Clinical • Cytokine release syndrome • PK/PD data • Hematological Malignancies • Inflammation • Multiple Myeloma • Oncology • IL6

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 (ASH 2024) - 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."

Clinical • P1 data • Anemia • Fatigue • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Leukopenia • Multiple Myeloma • Neutropenia • Novel Coronavirus Disease • Oncology • Pneumonia • Respiratory Diseases • Thrombocytopenia • CD8 • IL6

Phase Ib Study Investigating the Safety, Pharmacokinetics, and Efficacy of Subcutaneous Administration of ABBV-383 in Patients With Relapsed/Refractory Multiple Myeloma (IMW 2024) - P1 | "The primary objectives are to characterize the safety, tolerability, and pharmacokinetics (PK) of ABBV-383 after single subcutaneous (SC) administration and IV administration thereafter (part 1) and after SC administration until the end of treatment (part 2), and to determine the dose of ABBV-383 that would yield exposures comparable to that of the IV administration. n/a"

Clinical • P1 data • PK/PD data • Hematological Malignancies • Multiple Myeloma • Oncology

CERVINO: A phase 3, multicenter, randomized, open-label study of ABBV-383 compared with standard available therapies in patients with relapsed or refractory multiple myeloma (RRMM) (IMW 2024) - P3 | "Patients are randomized 1:1 to receive IV ABBV-383 60 mg Q4W without step-up dosing or investigator's choice of SAT (carfilzomib + dexamethasone, elotuzumab + pomalidomide + dexamethasone, or selinexor + bortezomib + dexamethasone), and will continue treatment until confirmed progressive disease or other discontinuation criteria are met. n/a"

Clinical • IO biomarker • P3 data • Hematological Malignancies • Inflammation • Multiple Myeloma • Oncology

Open-Label Phase 1b Study to Evaluate the Safety and Efficacy of ABBV-383 Monotherapy in Patients With Relapsed or Refractory Light Chain Amyloidosis (IMW 2024) - P1/2 | "n/a"

Clinical • IO biomarker • Monotherapy • P1 data • Amyloidosis • Hematological Disorders • Hematological Malignancies • Inflammation • Multiple Myeloma • Oncology

Efficacy and Safety of ABBV-383, a BCMA Bispecific Antibody, in Black Patients With Relapsed/Refractory Multiple Myeloma: A Subgroup Analysis of a Phase 1 Trial (IMW 2024) - P1/2, P3 | "ABBV-383 demonstrated a tolerable safety profile and antitumor activity in Black/African American pts that was comparable with the total pt population (Rodriguez et al. ASCO 2024. Abstract 7531; Weisel et al."

Clinical • P1 data • Anemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Novel Coronavirus Disease • Oncology • Pneumonia • Respiratory Diseases • Thrombocytopenia

Digital Remote Patient Monitoring for Cytokine Release Syndrome in ABBV-383 Treatment: Methodology and Setup (IMW 2024) - P1, P3 | "Selected trials within the ABBV-383 clinical trial program will utilize digital remote patient monitoring to comprehensively evaluate CRS, with the aim to identify early warning signs of CRS and assess the effectiveness of interventions. The findings from this study will contribute to a better understanding of CRS, inform the needed resource utilization with respect to routine monitoring and required hospitalization, and guide personalized interventions in patients receiving ABBV-383."

Clinical • Cytokine release syndrome • Hematological Malignancies • Inflammation • Multiple Myeloma • Oncology

A Study to Assess Adverse Events of Intravenously (IV) Infused ABBV-383 in Adult Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=180 | Recruiting | Sponsor: TeneoOne Inc. | N=120 ➔ 180 | Trial completion date: Jul 2026 ➔ Mar 2027 | Trial primary completion date: Jul 2026 ➔ Mar 2027

Adverse events • Enrollment change • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

CORRELATIVE BIOMARKER ANALYSES FOR OPTIMAL THERAPEUTIC DOSE DETERMINATION OF ABBV-383, A B-CELL MATURATION ANTIGEN X CD3 BISPECIFIC ANTIBODY, IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (EHA 2024) - P1/2 | " Peripheral blood and serum samples from patients with relapsed/refractory multiple myeloma (RRMM)enrolled in the phase 1 open-label, dose-expansion study (NCT03933735) who received ABBV-383 at 20, 40, or60 mg Q3W or 60 mg Q4W were collected at baseline (post-dexamethasone, pre–ABBV-383), on treatment,and at disease progression. High-avidity BCMA binding coupled to low-affinity T-cell engagement distinguishesthe resulting mechanism of action for ABBV-383. Responses to 60 mg Q4W ABBV-383 were independent ofbaseline sBCMA levels and resulted in rapid and transient proinflammatory cytokine production that promotedrobust T-cell redistribution, activation, and proliferation, indicating that the optimal dose of ABBV-383maximizes its clinical potential as a convenient, safe, and effective therapy for MM."

Biomarker • Clinical • IO biomarker • Hematological Malignancies • Multiple Myeloma • Oncology • CD69 • CD8 • CXCL8 • HAVCR2 • IL10 • IL6 • PD-1 • TINCR • TNFA

EFFICACY, SAFETY, AND DETERMINATION OF RP2D OF ABBV-383, A BCMA BISPECIFIC ANTIBODY, IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM). (EHA 2024) - P1/2, P3 | "A modified dexamethasone premedicationschedule and shortened CRS monitoring period were implemented in the 60mg Q4W cohort for cycle 1. The optimal therapeutic dose of 60mg Q4W ABBV-383 monotherapy was selected onthe basis of safety, efficacy, and ER analyses. The extended interval of Q4W, with a shortened CRS monitoringperiod in cycle 1 and no step-up dosing, will improve convenience and reduce the treatment burden for pts. ABBV-383 at 60mg Q4W will be investigated in the registrational phase 3 trial (NCT06158841) in RRMM."

Clinical • Anemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Oncology • Thrombocytopenia

A Study to Assess Adverse Events and Change in Disease State of Intravenously (IV) Infused ABBV-383 of Adult Participants With Relapsed or Refractory Multiple Myeloma in Japan (clinicaltrials.gov) - P1 | N=8 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: Mar 2024 ➔ Mar 2025 | Trial primary completion date: Mar 2024 ➔ Mar 2025

Adverse events • Monotherapy • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Study of ABBV-383 Assessing Adverse Events and Clinical Activity With Subcutaneous (SC) Injection in Adult Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=55 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2024 ➔ Jun 2024

Adverse events • Enrollment open • Trial initiation date • Hematological Malignancies • Multiple Myeloma • Oncology

Correlative biomarker analyses for optimal therapeutic dose determination of ABBV-383, a B-cell maturation antigen (BCMA) x CD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma (RRMM). (ASCO 2024) - P1/2 | " Peripheral blood and serum samples from patients with RRMM enrolled in the phase 1 open-label, dose-expansion study (NCT03933735) who received ABBV-383 at 20, 40, or 60 mg Q3W or 60 mg Q4W were collected at baseline (post-dexamethasone, pre–ABBV-383), on treatment, and at disease progression. High-avidity BCMA binding coupled to low-affinity T-cell engagement distinguishes the resulting mechanism of action for ABBV-383. Responses to 60 mg Q4W ABBV-383 were independent of baseline sBCMA levels and resulted in rapid and transient proinflammatory cytokine production that promoted robust T-cell redistribution, activation, and proliferation, indicating that the optimal dose of ABBV-383 maximizes its clinical potential as a convenient, safe, and effective therapy for MM."

Biomarker • Clinical • IO biomarker • Hematological Malignancies • Inflammation • Multiple Myeloma • Oncology • CD69 • CD8 • HAVCR2 • PD-1

Exposure-response analyses for optimal therapeutic dose selection of ABBV-383 in patients with relapsed/refractory multiple myeloma (RRMM). (ASCO 2024) - P1/2, P3 | "Dexamethasone premedication (36 vs 10 mg) was included in CRS models. 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."

Clinical • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Neutropenia • Oncology

AbbVie Advances Oncology Pipeline With Start of Multiple Myeloma Phase 3 Clinical Trial for Investigational Asset ABBV-383 (PRNewswire) - "AbbVie...announced that the first patient has been treated with investigational ABBV-383 in the CERVINO Phase 3 study. ABBV-383 is a distinctive B-cell maturation antigen (BCMA) and CD3 bispecific antibody T-cell engager composed of bivalent BCMA-binding domains allowing for high BCMA-avidity and a low-affinity CD3 binding domain. ABBV-383 is being evaluated in a Phase 3, multicenter, randomized, open-label study compared with standard available therapies in patients with r/r MM who received at least two lines of prior therapy."

Trial status • Hematological Malignancies • Multiple Myeloma • Oncology

Efficacy, safety, and determination of RP2D of ABBV-383, a BCMA bispecific antibody, in patients with relapsed/refractory multiple myeloma (RRMM). (ASCO 2024) - P1/2, P3 | "A modified dexamethasone premedication schedule and shortened CRS monitoring period were implemented in the 60mg Q4W cohort for cycle 1. The optimal therapeutic dose of 60mg Q4W ABBV-383 monotherapy was selected on the basis of safety, efficacy, and ER analyses. The extended interval of Q4W, with a shortened CRS monitoring period in cycle 1 and no step-up dosing, will improve convenience and reduce the treatment burden for pts. ABBV-383 at 60mg Q4W will be investigated in the registrational phase 3 trial (NCT06158841) in RRMM."

Clinical • Anemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Oncology • Thrombocytopenia

Study Assessing Activity of Intravenous (IV) ABBV-383 Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P3 | N=380 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Hematological Malignancies • Multiple Myeloma • Oncology

A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Immunoglobulin Light Chain (AL) Amyloidosis Receiving ABBV-383 as an Intravenous (IV) Infusion (clinicaltrials.gov) - P1/2 | N=76 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Adverse events • Enrollment open • Amyloidosis

A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=270 | Recruiting | Sponsor: TeneoOne Inc. | Trial completion date: Nov 2028 ➔ Jul 2031

Adverse events • Combination therapy • Trial completion date • Hematological Malignancies • Multiple Myeloma • Oncology

A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Immunoglobulin Light Chain (AL) Amyloidosis Receiving ABBV-383 as an Intravenous (IV) Infusion (clinicaltrials.gov) - P1/2 | N=76 | Not yet recruiting | Sponsor: AbbVie | Phase classification: P1 ➔ P1/2

Adverse events • Phase classification • Amyloidosis