AbbVie's dual-acting myeloma drug etentamig
AbbVie reported that its bispecific antibody etentamig met the primary endpoint in a Phase 3 trial for multiple myeloma, reducing progression or death risk
AbbVie announced that its dual-acting drug etentamig achieved the main goal of a Phase 3 clinical trial in patients with multiple myeloma who had received two or more prior lines of therapy. The trial showed that etentamig helped patients survive longer without disease progression compared to those receiving standard treatment regimens.
Etentamig is a bispecific antibody designed to bind both to tumor cells and T cells, thereby activating the immune system to attack multiple myeloma. The drug trails the first-in-class bispecific antibody Tecvayli from Johnson & Johnson by more than four years, with Tecvayli recording $462 million in sales during the first half of 2026.
The trial enrolled 421 participants with relapsed or refractory multiple myeloma, randomly assigning half to receive etentamig. At a pre-planned interim analysis, independent monitors observed a statistically significant difference between the treatment and control groups, leading to trial unblinding. A total of 393 patients were evaluable, with an average follow-up of 11 months from trial entry.
On efficacy, etentamig reduced the risk of disease progression or death by 60% compared to standard therapies. A response was observed in 74% of patients receiving etentamig, significantly higher than the 46% response rate in the standard therapy group.
Regarding safety, 28% of patients in the etentamig group experienced cytokine release syndrome (CRS), and only one case of immune effector cell-associated neurotoxicity syndrome (ICANS) was reported. This contrasts with higher rates seen in other bispecific antibodies: nearly three-quarters of Tecvayli patients developed CRS, over half of those on Pfizer’s Elrexfio experienced CRS, and 46% of patients on Regeneron’s Lynozyfic had CRS. Most CRS events in the etentamig trial were mild.
Peter Voorhees, a trial investigator and chief of the plasma cell disorders division at Atrium Health Levine Cancer Institute, stated that etentamig’s safety profile "has the potential to provide access across a range of treatment settings beyond specialized treatment centers and into outpatient and community-based settings," in a statement provided by AbbVie.
AbbVie said it will discuss the trial results with regulatory agencies and present the data later this month at the International Myeloma Society Annual Meeting.
