Etentamig Improves Responses and Progression-Free Survival in Relapsed Multiple Myeloma

AbbVie announced that the investigational treatment etentamig improved response rates and progression-free survival compared with standard available therapies in patients with relapsed/refractory multiple myeloma. The findings come from the phase 3 CERVINO trial, which included 393 patients who had previously received a median of three lines of treatment.

Etentamig is an investigational treatment designed to help the immune system recognize and attack multiple myeloma cells. In the CERVINO trial, it met both primary goals of the study: objective response rate and progression-free survival.

An objective response means that a patient's cancer shrinks or disappears in response to treatment. Progression-free survival refers to how long patients live without their cancer getting worse or dying from any cause.

After a median follow-up of 11.4 months, 74% of patients who received etentamig responded to treatment compared with 45.7% of those who received standard available therapies. Etentamig also reduced the risk of disease progression or death by 60% compared with standard therapies.

The findings are topline results from the first planned efficacy analysis of CERVINO. Full results are scheduled to be presented at the 23rd International Myeloma Society Annual Meeting on Sept. 25, 2026, in Glasgow, Scotland.

How did etentamig affect response rates and progression-free survival?

The CERVINO trial found that patients receiving etentamig were more likely to respond to treatment than those receiving standard available therapies.

Overall, 74% of patients receiving etentamig responded to treatment compared with 45.7% of patients receiving standard available therapies. This means nearly three out of every four patients treated with etentamig experienced a response, compared with fewer than half of patients receiving standard available therapies.

The study also found a benefit in progression-free survival. Patients receiving etentamig had a 60% lower risk of their disease progressing or dying compared with patients receiving standard available therapies.

The progression-free survival benefit was observed across all prespecified subgroups evaluated in the study.

The trial also evaluated overall survival, which measures how long patients remain alive after entering a study. At 12 months, 87.9% of patients receiving etentamig were alive compared with 72% of those receiving standard available therapies.

However, the study's prespecified threshold for showing an overall survival benefit had not been reached at the time the data were analyzed. Therefore, the overall survival findings are not considered one of the trial's primary findings at this point.

What did the phase 3 CERVINO trial evaluate?

CERVINO is a global, randomized phase 3 trial evaluating etentamig against standard available therapies in patients with relapsed/refractory multiple myeloma.

The 393 patients included in the analysis had received a median of three previous lines of treatment. All patients had been exposed to a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 monoclonal antibody.

These are three major classes of multiple myeloma treatments. Patients in the study therefore had previously received several types of treatment before entering the trial.

Patients were randomly assigned to receive either etentamig or an investigator's choice of standard available therapy.

Those receiving etentamig were given one initial step-up dose followed by treatment once every four weeks. The step-up dose gradually introduces the treatment before patients move to the regular dosing schedule.

Patients assigned to standard available therapy could receive carfilzomib plus dexamethasone, elotuzumab plus pomalidomide and dexamethasone or selinexor plus bortezomib and dexamethasone.

The primary goals of the trial were to determine how many patients responded to treatment and how long patients lived without their disease getting worse or dying.

The study also evaluated overall survival, how deeply the cancer responded to treatment, whether patients had no detectable disease using a test for measurable residual disease, disease symptoms and physical functioning.

Etentamig is a bispecific T-cell engager that targets BCMA and CD3. BCMA is a protein found on the surface of malignant plasma cells in multiple myeloma. The treatment is designed to connect T cells, a type of immune cell, with multiple myeloma cells.

Etentamig remains investigational and has not been approved for use by global regulatory authorities. AbbVie plans to discuss the CERVINO results with global regulatory authorities to determine next steps.

What side effects were reported with etentamig?

The study also evaluated the safety of etentamig, including infections and immune-related side effects.

Grade 3 (severe) or 4 (life-threatening) infections, which are considered more severe, occurred in 27.7% of patients receiving etentamig compared with 19.2% of patients receiving standard available therapies.

Fatal infections occurred in 1.5% of patients receiving etentamig compared with 3.1% of patients receiving standard available therapies.

One side effect of particular interest with etentamig was cytokine release syndrome, or CRS. CRS is an immune reaction that can occur when certain cancer treatments activate immune cells. Symptoms can vary in severity.

Among patients receiving the single step-up dose, CRS occurred in 28.3% of patients. Most cases were grade 1, occurring in 23.9% of patients. No grade 3 or higher CRS events were reported.

The study also reported one case of immune effector cell-associated neurotoxicity syndrome, known as ICANS. ICANS is a neurological side effect associated with certain immune-based cancer treatments. The single reported case occurred in 0.9% of patients and was grade 1. No grade 2 or higher cases were reported.

Treatment-emergent side effects that resulted in patients stopping treatment occurred in 3.6% of patients receiving etentamig compared with 9.6% of patients receiving standard available therapies.

Etentamig is an investigational treatment and has not been approved by global regulatory authorities. AbbVie plans to discuss the CERVINO results with regulatory authorities to determine the next steps for the treatment.

References

1. “CERVINO: Phase 3 Results of Etentamig vs. Investigator's Choice of Standard Available Therapies in Triple-Class Exposed Relapsed or Refractory Multiple Myeloma (RRMM)” News Release. AbbVie, Sept. 3, 2026.

For more news on cancer updates, research and education, don't forget to subscribe to CURE®'s newsletters here.