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

Phase 1/2, Open-Label, Platform Study of Surzetoclax with Etentamig in Biomarker-Selected Patients with Relapsed/Refractory Multiple Myeloma (RRMM) (IMS 2026) - P1/2 | "Venetoclax, a first-in-class BCL2 inhibitor (BCL2i), has shown efficacy in RRMM. N/A"

Biomarker • Clinical • IO biomarker • P1/2 data • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma

Etentamig in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM) with Prior Exposure to B-Cell Maturation Antigen (Bcma)-Targeted Therapy (IMS 2026) - P1 | "Even after prior BCMA exposure, treatment with etentamig led to deep and durable responses , with particularly encouraging responses post-BMCA CAR-T . Consistent with prior data, only low-grade CRS was observed, even without SUD with no new safety signals."

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

A Phase 1/2, Open-Label, Platform Study to Evaluate the Safety and Efficacy of Etentamig Monotherapy or Combination Therapy in Patients with Multiple Myeloma (IMS 2026) - P1/2 | "If combined with daratumumab, etenta will be initiated as from C1D8, while lenalidomide and carfilzomib will be initiated from C2D1. This trial in progress highlights ongoing efforts to develop novel therapies for MM to improve pt outcomes."

Clinical • Combination therapy • IO biomarker • Monotherapy • P1/2 data • Hematological Malignancies • Multiple Myeloma

Etentamig Combined With Pomalidomide Plus Dexamethasone (Pom+Dex) in Relapsed/Refractory Multiple Myeloma (RRMM) After 1-3 Prior Lines of Therapy: A Phase 1b Dose-Escalation and Safety Expansion Study (IMS 2026) - P1 | " Arm E of this multi-arm, open-label, multicenter, Phase 1b dose-escalation and -expansion study enrolled pts ≥18 years old with RRMM after 1–3 PLT, including lenalidomide. Consistent with the previously reported Arm A data, the etentamig plus pom+dex combination led to deep responses. Considering the shorter Arm E follow-up time, the introduction of a single SUD, as well as delayed pom administration in Arm E, further reduced CRS and infection risk, mirroring etentamig monotherapy rates. These data support further exploration of the regimen in a randomized Phase 3 study."

Clinical • P1 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Neutropenia

CERVINO: A Randomized Phase 3 Study of Etentamig vs Investigator's Choice of Standard Available Therapies in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) and Triple-Class Exposure (IMS 2026) - P3 | "Pts were randomized 1:1 to Etenta Q4W or SAT (carfilzomib + dexamethasone [Kd], elotuzumab + pomalidomide + d [EloPd], or selinexor + bortezomib + d [SVd]). In heavily pretreated pts with triple-class exposed RRMM, Etenta significantly improved ORR and PFS vs SAT, with an early positive OS signal. A single SUD andQ4Wdosing from initiation were associated with very low rates of CRS, ICANS, and ≥ G3 infections, reinforcing Etenta’s best-in-class safety potential. Data support Etenta monotherapy as a new standard of care with convenient dosing suitable for global outpatient and community use."

Clinical • Late-breaking abstract • P3 data • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma

AbbVie announces encouraging preliminary data of etantamig in relapsed or refractory multiple myeloma (Demócrata) - "After a median follow-up of 11.4 months, the drug showed statistically significant and clinically relevant efficacy, along with a safety profile considered manageable. Specifically, an objective response rate (ORR) of 74 percent was observed and a 60 percent reduction in the risk of progression or death compared to the standard alternatives chosen by the investigator. Furthermore, the overall survival at 12 months reached 87.9 percent, compared to 72 percent recorded with standard treatments."

P3 data • Multiple Myeloma

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

CERVINO: Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P3 | N=421 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • 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=680 | Recruiting | Sponsor: AbbVie | Trial completion date: Jan 2042 ➔ May 2041 | Trial primary completion date: Jan 2042 ➔ Sep 2040

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

Phase 1/2 dose escalation and expansion study of etentamig in patients with relapsed or refractory light chain amyloidosis (ASH 2025) - P1/2, P3 | "Thirty-three percent have received a prior stem celltransplant and 50% previously received the regimen of daratumumab with cyclophosphamide,bortezomib, and dexamethasone in combination. Additional dose-level datawill be presented at the time of the meeting. All pts remain in ongoing follow-up and evaluation, and thestudy will begin the dose expansion (EXP) portion after dose selection."

Clinical • P1/2 data • Amyloidosis • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Multiple Myeloma • Neutropenia • Thrombocytopenia

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

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

AbbVie to Present Phase 3 Etentamig Results and Data from Broad Multiple Myeloma Portfolio at the 2026 International Myeloma Society (IMS) Meeting (PRNewswire) - "Plenary presentation will feature Phase 3 CERVINO results demonstrating that etentamig met the study's dual primary endpoints of objective response rate (ORR) and progression-free survival (PFS) in relapsed/refractory multiple myeloma (RRMM); Additional presentations highlight research across the breadth of AbbVie's multiple myeloma portfolio, including ABBV-2001 (ISB 2001), a trispecific T-cell engager and surzetoclax, a BCL-2 inhibitor, and combination approaches....Additional presentations from these investigational assets will explore treatment sequencing, infection-related healthcare utilization and costs, and real-world outcomes, reinforcing AbbVie's strategy to advance understanding of disease heterogeneity, mechanisms of resistance and the evolving needs of patients living with multiple myeloma."

Clinical data • P1/2 data • P3 data • Multiple Myeloma

Etentamig in patients (pts) with relapsed/refractory multiple myeloma (RRMM) with prior exposure to B-cell maturation antigen (BCMA)–targeted therapy. (ASCO 2026) - P1 | "Pts treated with etentamig achieved durable responses; rates were higher in pts who received CAR-T as last line. No new safety signals were observed; only low-grade CRS was seen despite no SUD."

Clinical • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Neutropenia • CD8

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

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

AbbVie Announces Positive Topline Results from the Phase 3 CERVINO Trial Showing Etentamig Significantly Improved Response Rate and Progression-Free Survival in Patients with Relapsed/Refractory Multiple Myeloma (PRNewswire) - "Full results will be presented in a plenary session at the 23rd International Myeloma Society Annual Meeting, taking place September 23-26, 2026...Significantly higher ORR with etentamig vs. SAT (74.0% [95% CI, 67.25–79.97] vs. 45.7% [95% CI, 38.59–52.91]; P<0.0001); Significantly improved PFS with etentamig vs. SAT (HR, 0.40; 95% CI, 0.29–0.54; P<0.0001)...12-month overall survival (OS) was 87.9% for etentamig vs. 72.0% for SAT (HR, 0.48; 95% CI: 0.29–0.77; nominal P=0.0012); prespecified efficacy boundary for OS was not crossed at data cutoff...This was the first planned efficacy interim analysis of the CERVINO study and, based on the significant benefit, the Independent Data Monitoring Committee (IDMC) recommended unblinding the study....AbbVie plans to discuss the Phase 3 CERVINO results with global regulatory authorities to determine next steps for etentamig."

DSMB • P3 data: top line • Multiple Myeloma

PHASE 1 DOSE ESCALATION SAFETY AND EFFICACY OF ETENTAMIG IN PATIENTS WITH RELAPSED OR REFRACTORY LIGHT CHAIN AMYLOIDOSIS (EHA 2026) - P1/2 | "Only Grade 1 CRS events were observed. CRS, cytokine release syndrome; Q4W, every 4 weeks."

Clinical • P1 data • Amyloidosis • Hematological Disorders • Infectious Disease • Inflammation • Neutropenia

Etentamig intravenous: Data readout from P3 CERVINO trial (NCT06158841) for 3L multiple myeloma in 2026 (AbbVie) - Q2 2026 Results

P3 data • Hematological Malignancies • Multiple Myeloma • Oncology

Etentamig intravenous: Regulatory submission for 3L multiple myeloma in 2026 (AbbVie) - Q2 2026 Results: Regulatory approval for 3L multiple myeloma in 2027

Approval • Filing • Hematological Malignancies • Multiple Myeloma • Oncology

A Study to Evaluate Adverse Events and Change in Disease Activity With Injected Etentamig Plus Oral Pomalidomide Versus Standard Therapies in Adults With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P3 | N=520 | Not yet recruiting | Sponsor: AbbVie

Adverse events • New P3 trial • Hematological Malignancies • Multiple Myeloma • Oncology

A Study to Assess Change in Disease Symptoms in Adult Participants With Relapsed or Refractory Multiple Myeloma Intravenously (IV) Infused ABBV-383 or Receiving Standard Available Therapies (clinicaltrials.gov) - P3 | N=380 | Not yet recruiting | Sponsor: AbbVie

Monotherapy • New P3 trial • Hematological Malignancies • Multiple Myeloma • Oncology