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

Salvage Therapies After Bispecific Antibody Relapse in Multiple Myeloma (HOPA 2026) - "The BsAb included for analysis were teclistamab, elrantamab, linvoseltamab, etentamig, and talquetamab. In Progress"

Bispecific • Endocrine Disorders • Hematological Malignancies • Metabolic Disorders • Multiple Myeloma • Renal Disease

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=60 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Adverse events • Enrollment closed • Hematological Malignancies • Multiple Myeloma • Oncology

Etentamig plus pomalidomide-dexamethasone combination therapy in relapsed or refractory multiple myeloma: A phase 1b dose-escalation and safety expansion study (ASH 2025) - P1, P1/2 | "Arm A evaluated etentamig in combination with POM+DEX in pts after≥3 prior lines of therapy (LoT), including the IMiD lenalidomide, a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody (mAB). Preliminary data are promising and suggest etentamig in combination with POM+DEX istolerable with robust efficacy (ORR and ≥VGPR: 81% and 72%, respectively) in pts with ≥3 prior LoT(median LoT = 4). In this heavily pretreated population, median PFS was not reached with a median followup of 18 months, suggesting prolonged disease control with etentamig in combination with POM+DEX.Overall, these data support further exploration of the regimen in a randomized Phase 3 study."

Clinical • Combination therapy • P1 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Influenza • Multiple Myeloma • Neutropenia • Pneumonia • Renal Disease • Respiratory Diseases

A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant (clinicaltrials.gov) - P2/3 | N=660 | Recruiting | Sponsor: AbbVie

Adverse events • Trial initiation date • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant (clinicaltrials.gov) - P2/3 | N=660 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Adverse events • Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

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 | Trial completion date: Feb 2027 ➔ Dec 2027

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

M25-586: A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants with Newly Diagnosed Multiple Myeloma Not Eligible for Transplant (clinicaltrialsregister.eu) - P2/3 | N=24 | Not yet recruiting | Sponsor: AbbVie Deutschland GmbH & Co. KG

Adverse events • New P2/3 trial • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

M22-574: A Phase 3 study of Etentamig vs Standard Available Therapies in Subjects with Relapsed or Refractory Multiple Myeloma (RRMM) (3L+ RRMM Monotherapy Study) (clinicaltrialsregister.eu) - P2/3 | N=147 | Active, not recruiting | Sponsor: AbbVie Deutschland GmbH & Co. KG | Recruiting ➔ Active, not recruiting

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

ABBV-383 for the Treatment of Relapsed Refractory Waldenström Macroglobulinemia (clinicaltrials.gov) - P1/2 | N=38 | Not yet recruiting | Sponsor: Mayo Clinic

New P1/2 trial • Hematological Disorders • Hematological Malignancies • Lymphoma • Lymphoplasmacytic Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Waldenstrom Macroglobulinemia

A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant (clinicaltrials.gov) - P2/3 | N=660 | Recruiting | Sponsor: AbbVie | Trial primary completion date: Oct 2041 ➔ Jan 2042

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

Etentamig intravenous: Data readout from P1 trial (NCT05259839) alone or etentamig combinations for 2L multiple myeloma in 2026 (AbbVie) - Q4 2025 Results: Data readout from P1 trial (NCT06892522) alone or etentamig combinations for multiple myeloma in 2027

P1 data • Hematological Malignancies • Multiple Myeloma • Oncology

Etentamig intravenous: Regulatory submission for 3L multiple myeloma in 2027 (AbbVie) - Q4 2025 Results

Filing • Hematological Malignancies • Multiple Myeloma • Oncology

A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant (clinicaltrials.gov) - P2/3 | N=660 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jan 2042 ➔ Oct 2041

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

Etentamig intravenous: ORR data from P3 CERVINO trial (NCT06158841) for multiple myeloma in 2026 (44th Annual J.P. Morgan Healthcare Conference, AbbVie)

P3 data • Hematological Malignancies • Multiple Myeloma • Oncology

Etentamig intravenous: ORR data from P3 CERVINO trial (NCT06158841) for multiple myeloma in 2026 (44th Annual J.P. Morgan Healthcare Conference, AbbVie)

P3 data • 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 • Oncology • Pneumonia • Respiratory Diseases • Thrombocytopenia

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) - P1, P1/2 | "Etenta with SUD demonstrated a low CRS incidence, durable response, and tolerability in pts with heavily pretreated RRMM. Efficacy across all subgroups was comparable and maintained, suggesting therapeutic benefits among a broad population and supporting further exploration in the ongoing Ph 3 Cervino study."

Clinical • Anemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Septic Shock • Thrombocytopenia

Updated Results of a Phase 1, First-in-Human Study of ABBV-383, a BCMA × CD3 Bispecific T-Cell Redirecting Antibody, in Patients with Relapsed/Refractory Multiple Myeloma (IMW 2022) - P1/2 | "ABBV-383 monotherapy demonstrates an acceptable and manageable safety with promising efficacy indicated by deep and durable responses with ORR of 60% (at 60mg) and median DOR not reached, supporting the development of ABBV-383 monotherapy in a heavily pretreated RRMM population with a high unmet need. Enrollment in the dose-expansion arm is ongoing with additional dose level of 40mg currently under exploration."

Clinical • P1 data • Anemia • Fatigue • Hematological Disorders • Hematological Malignancies • Inflammation • Multiple Myeloma • Oncology

A Phase I First-in-Human Study of ABBV-383, a B-Cell Maturation Antigen × CD3 Bispecific T-Cell Redirecting Antibody, in Patients With Relapsed/Refractory Multiple Myeloma. (PubMed, J Clin Oncol) - P1/2 | "ABBV-383 in patients with RRMM was well tolerated with an ORR of 68% at doses ≥ 40 mg. This novel therapy's promising preliminary antitumor activity in heavily pretreated patients warrants further clinical evaluation."

Journal • P1 data • Fatigue • Hematological Malignancies • Immune Modulation • Inflammation • Multiple Myeloma • Neutropenia

A Phase 1 First-in-Human Study of Abbv-383, a BCMA × CD3 Bispecific T-Cell–Redirecting Antibody, As Monotherapy in Patients with Relapsed/Refractory Multiple Myeloma (ASH 2022) - P1/2 | "Enrollment in 40mg EXP cohort is ongoing (n=42 currently enrolled). Updated data from these pts will be presented."

Clinical • IO biomarker • Monotherapy • P1 data • Anemia • Hematological Disorders • Hematological Malignancies • Immune Modulation • Infectious Disease • Inflammation • Multiple Myeloma • Neutropenia • Oncology • Thrombocytopenia

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

Hematotoxicity and immune deficits with bispecific antibodies: A systematic review and meta-analysis in lymphoma and multiple myeloma (ASH 2025) - "Among NHL cohorts, the BsAb distribution was: 7 glofitamab, 6 mosunetuzumab, 5 epcoritamab, and 4 odronextamab. Among MM cohorts, 6 received teclistamab, 3 talquetamab, 1 teclistamab and talquetamab, 2 elranatamab, 2 linvoseltamab and 1 etentamig (ABBV-383)... Cytopenias affect a substantial proportion of patients treated with BsAbs, particularly in MM and in NHL with combination regimes. These findings support the need for systematic hematologic monitoring, IG surveillance and tailored pre-emptive strategies to mitigate infection risk.This study represents the first and most comprehensive meta-analysis of hematotoxicity and immune deficits with BsAbs, establishing a benchmark across clinical settings."

Retrospective data • Review • Hematological Malignancies • Infectious Disease • Lymphoma • Multiple Myeloma • Neutropenia • Non-Hodgkin’s Lymphoma • Thrombocytopenia

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=283 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Enrollment closed • 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 Etentamig (ABBV-383) as an Intravenous (IV) Infusion (clinicaltrials.gov) - P1/2 | N=76 | Recruiting | Sponsor: AbbVie | Trial completion date: Feb 2028 ➔ Sep 2031 | Trial primary completion date: Oct 2026 ➔ Sep 2031

Adverse events • Trial completion date • Trial primary completion date • Amyloidosis

Ultra-sensitive detection of clonal m-protein by mass spectrometry enhances detection of residual disease: Results from A phase 1 study of etentamig monotherapy in patients with relapsed or refractory multiple myeloma (ASH 2025) - P1/2 | "Using MS-based clonotypic peptide detection, rapid and deep decline in serum M-proteinlevels was observed in RRMM patients treated with etentamig. Strong concordance was observedbetween MS M-protein levels and IMWG response, including in patients achieving MRD-negative CR at<10-5 and 10-6 thresholds. Non-invasive and ultra-sensitive M-protein detection is feasible in MM and mayserve as a key biomarker for enhancing the detection of residual disease in the future."

Clinical • IO biomarker • Monotherapy • P1 data • Residual disease • Hematological Malignancies • Multiple Myeloma