Dive Brief:
- AbbVie said its dual-acting drug for multiple myeloma met the main goal of a Phase 3 clinical trial, helping people who’ve progressed on two or more lines of therapy survive longer without progression than those who received standard treatment regimens, the company said Thursday.
- The drug, called etentamig, could be safer than rival drugs launched by Johnson & Johnson, Pfizer and Regeneron, with low rates of two kinds of serious immune responses common to other drugs of its type. AbbVie said its safety profile could enable greater use in community oncology centers because of reduced need for post-treatment patient monitoring.
- Etentamig is a type of drug called a bispecific antibody that can simultaneously bind to diseased tumor cells and T cells, triggering an immune response to fight multiple myeloma. It trails by more than four years the first drug in its class, J&J’s Tecvayli, which booked $462 million in sales through the first six months of 2026.
Dive Insight:
Immunotherapy has reshaped care across nearly every type of cancer, and the blood cancers like leukemia, lymphoma and multiple myeloma have been part of that transformation. In blood cancers, it first started with a type of engineered cell treatment called CAR-T therapy, and dual-acting bispecific antibodies have followed closely behind.
Bispecific antibodies have an advantage against CAR-T therapies, which require extensive re-engineering of patients’ own cells to fight cancer. But they still carry some of the same safety issues, specifically immune responses called cytokine release syndrome and a neurological condition called ICANS, which have required similar post-treatment monitoring protocols that patients who receive CAR-T therapies have to undergo.
Oncologists have been refining those monitoring protocols to enable more patients to bypass inpatient stays, such as giving them their own tools to monitor symptoms as well as preventive treatments. A drug with reduced side effects could have an edge, however.
AbbVie’s trial enrolled 421 people with multiple myeloma, and randomized half to get etentamig. Independent trial monitors detected a significant difference between the two groups at a pre-planned interim checkpoint, prompting investigators to unblind the trial, leaving 393 people evaluable at an average of 11 months after trial entry.
On efficacy, etentamig reduced the risk of progression or death by 60% compared with standard therapies, and stimulated a response in 74% of the enrollees who got it, significantly more than the 46% of those on standard therapies who responded, AbbVie said.
On safety, 28% got CRS in the etentamig group, and only one got ICANS. By comparison, in clinical trials nearly three-quarters of Tecvayli patients got CRS, along with more than half of people who received Pfizer’s Elrexfio and 46% of those who got Regeneron’s Lynozyfic. Most participants in AbbVie’s trial who developed CRS also only experienced a mild form of the immune response.
The profile gives etentamig “the potential to provide access across a range of treatment settings beyond specialized treatment centers and into outpatient and community-based settings,” said Peter Voorhees, a trial investigator and chief of the plasma cell disorders division at Atrium Health Levine Cancer Institute, in a statement provided by AbbVie.
AbbVie said it will discuss the trial results with regulators and present the data later this month at the International Myeloma Society Annual Meeting.
