Etentamig Reduces Risk of Progression or Death by 60% in Relapsed/Refractory Multiple Myeloma

Etentamig, an investigational B-cell maturation antigen (BCMA)–directed bispecific antibody, reduced the risk of disease progression or death by 60% compared with standard available therapies in patients with relapsed or refractory multiple myeloma, according to topline results from the phase 3 CERVINO trial (NCT06158841).¹

The trial met both of its primary end points: progression-free survival (PFS) and overall response rate (ORR). Etentamig produced an ORR of approximately 74.0%, compared with 45.7% among patients who received an investigator-selected standard regimen.¹ The findings support continued evaluation of etentamig as an off-the-shelf immunotherapy for patients whose disease has progressed after established drug classes.

CERVINO Evaluates Monthly Bispecific Antibody

CERVINO is a global, randomized, open-label phase 3 trial comparing etentamig monotherapy with standard available therapy. The study enrolled 393 adults with relapsed or refractory multiple myeloma who had received a median of 3 prior lines of treatment.¹

Eligible patients had prior exposure to a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Patients previously treated with a BCMA-directed therapy were excluded.²

Participants were randomly assigned to intravenous etentamig or an investigator-selected regimen. Standard therapy options included carfilzomib plus dexamethasone; elotuzumab, pomalidomide, and dexamethasone; or selinexor, bortezomib, and dexamethasone. Etentamig was administered at 60 mg once every 4 weeks.²

In addition to the 60% reduction in the risk of progression or death, the 12-month overall survival (OS) rate was approximately 87.9% with etentamig compared to 72.0% with standard therapy.¹ OS was among the trial’s secondary end points, along with complete response, very good partial response, minimal residual disease negativity, and changes in symptoms and physical functioning.²

Full efficacy and safety findings have not yet been presented in a peer-reviewed publication. The topline announcement did not provide median PFS, duration of response, rates of cytokine release syndrome, or other adverse event data. These data can be important for determining how etentamig compares with existing BCMA-directed bispecific antibodies.

Etentamig Targets BCMA and CD3

Etentamig, previously known as ABBV-383, is designed to engage BCMA on myeloma cells and CD3 on T cells, redirecting the immune response toward malignant plasma cells. The molecule contains 2 BCMA-binding domains intended to increase binding avidity and a low-affinity CD3-binding domain designed to limit cytokine release.³

Its silenced Fc region extends the molecule’s half-life, allowing administration once every 4 weeks from the beginning of treatment.³ This schedule could reduce the number of treatment visits compared with therapies requiring more frequent administration, although the effect on overall treatment burden must be evaluated alongside monitoring and supportive-care requirements.

Unlike autologous CAR T-cell therapy, a bispecific antibody does not require patient-specific cell collection and manufacturing. This distinction could allow treatment to begin sooner and make BCMA-directed therapy available at centers without the infrastructure required to deliver CAR T-cell products. The CERVINO trial did not enroll patients who were previously exposed to BCMA-targeted therapy, therefore, the current results do not establish etentamig’s efficacy following a BCMA-directed CAR T-cell therapy or another BCMA bispecific antibody.²

Pharmacy Considerations Remain Central

If approved by the FDA, etentamig would add another option to an increasingly complex relapsed multiple myeloma treatment landscape. Pharmacists would help evaluate prior treatment exposure, confirm regimen eligibility, and coordinate monthly infusions. Monitoring plans would also need to address the toxicities associated with T-cell–engaging therapy, including cytokine release syndrome, cytopenias, and infections.

The CERVINO results demonstrate a substantial improvement over physician-selected therapy in a heavily pretreated population. Still, the absence of complete safety findings limits conclusions about the benefit-risk profile. Longer follow-up will also clarify response durability and whether the early OS difference persists.

Etentamig remains investigational and is not approved by the FDA. The forthcoming presentation of complete CERVINO results will provide the data needed to assess its place among available bispecific antibodies and other immune-based treatments for relapsed or refractory multiple myeloma.

REFERENCES

1. Singh P. AbbVie’s blood cancer therapy lowers disease progression, death risk in trial. Reuters. September 3, 2026. Accessed September 21, 2026. https://www.reuters.com/business/healthcare-pharmaceuticals/abbvies-blood-cancer-drug-meets-late-stage-trial-goals-2026-09-03/

2. National Cancer Institute. Study assessing activity of intravenous etentamig monotherapy versus standard available therapies in adult participants with relapsed or refractory multiple myeloma. Accessed September 21, 2026. https://www.cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-03444

3. AbbVie advances oncology pipeline with start of multiple myeloma phase 3 clinical trial for investigational asset ABBV-383. News release. AbbVie. June 5, 2024. Accessed September 21, 2026. https://news.abbvie.com/2024-06-05-AbbVie-Advances-Oncology-Pipeline-With-Start-of-Multiple-Myeloma-Phase-3-Clinical-Trial-for-Investigational-Asset-ABBV-383

4. AbbVie Clinical Trials. Study M22-574: etentamig monotherapy versus standard available therapies in relapsed or refractory multiple myeloma. Accessed September 21, 2026. https://www.abbvieclinicaltrials.com/study/M22-574