AbbVie’s Etentamig Shows Strong Results in Phase 3 Blood Cancer Study

Key Points

• AbbVie’s experimental drug etentamig helped more patients with hard-to-treat multiple myeloma respond to treatment than standard therapies.
• The drug cut the risk of the cancer getting worse or causing death by 60% in the Phase 3 CERVINO trial.
• Etentamig is given once a month after an initial dose, which could make treatment more convenient for patients.
• AbbVie plans to share full results later this month and discuss the data with health regulators.

AbbVie (NYSE: ABBV) reported positive Phase 3 results for etentamig, an experimental treatment for people with relapsed or refractory multiple myeloma.

Multiple myeloma is a blood cancer that starts in plasma cells in the bone marrow. It can cause bone pain, fractures, infections, and other serious health problems. While treatments have improved, the disease is still not considered curable, and many patients eventually see their cancer return or stop responding to treatment.

The CERVINO study compared AbbVie’s etentamig with standard treatments in 393 patients whose multiple myeloma had come back or had not responded to earlier therapies.

More Patients Responded to Etentamig

After about 11 months of follow-up, 74% of patients who received etentamig saw their cancer shrink or improve. That compared with 45.7% of patients who received standard available treatments.

Etentamig also helped patients go longer without their disease getting worse. The treatment reduced the risk of cancer progression or death by 60% compared with standard therapies.

At one year, 87.9% of patients treated with etentamig were still alive, compared with 72.0% of patients receiving standard therapies. However, the study had not yet reached the level needed to confirm a statistically significant overall-survival benefit.

Treatment Is Given Once a Month

Etentamig is a type of immune-based cancer treatment. It is designed to help the body’s T cells, which are immune cells, find and attack myeloma cells.

The treatment targets a protein called BCMA that appears on myeloma cells. It also attaches to T cells, bringing the immune cells close enough to attack the cancer.

Patients receive one initial step-up dose before moving to monthly treatment. AbbVie said the schedule could make etentamig more convenient than therapies that require more frequent dosing or specialized treatment settings.

Side Effects Remain an Important Consideration

Immune treatments for multiple myeloma can trigger cytokine release syndrome, or CRS. CRS happens when the immune system becomes highly activated and can cause fever and other symptoms.

In the study, CRS occurred in 28.3% of patients receiving the initial etentamig dose. Most cases were mild, and no severe Grade 3 or higher CRS cases were reported.

One patient experienced a mild neurological side effect called ICANS. The trial did not report any moderate or severe ICANS cases.

Serious infections occurred more often with etentamig. Grade 3 or 4 infections occurred in 27.7% of etentamig-treated patients, compared with 19.2% of patients receiving standard therapies. Fatal infections occurred in 1.5% of patients receiving etentamig and 3.1% of patients receiving standard treatments.

AbbVie Prepares Full Data Release

An independent group that monitors clinical trials recommended that AbbVie unblind the CERVINO study after reviewing the planned interim results.

AbbVie plans to present the full findings at the International Myeloma Society Annual Meeting from September 23 to 26 in Glasgow, Scotland. The company also plans to discuss the results with health regulators.

Etentamig has not been approved for use. The treatment will need to undergo further review before it could become available to patients.