AbbVie files U.S. application for etentamig after response rate rises to 74.0%
Key Facts
AbbVie has submitted a biologics license application to the U.S. Food and Drug Administration for etentamig to treat adults with relapsed or refractory multiple myeloma, the company said. The filing follows positive Phase 3 results from the CERVINO study, which compared the drug with investigator-selected standard treatments in previously treated patients. The results showed an overall response rate of 74.0% with etentamig, compared with 45.7% with standard treatment, a statistically significant difference. This marks progress for the drug from trial results to regulatory review, but does not mean it has been approved. The drug remained investigational and unapproved for use by global regulators when the study results were announced.
On another efficacy measure, progression-free survival improved with etentamig compared with standard treatments, with a hazard ratio of 0.40. Median progression-free survival in the etentamig group had not reached an estimated value when the study results were presented, compared with 6.2 months in the standard-treatment group. The CERVINO analysis included patients who had received a median of three lines of therapy, placing the results in the context of patients who had undergone extensive treatment before entering the study. Median follow-up was 11.4 months, the period on which the reported analysis was based. Peter Voorhees, an investigator in the study, said the drug showed "clinically meaningful improvement in progression-free survival and response rates, along with a manageable safety profile."
Overall survival at 12 months was 87.9% with etentamig, compared with 72.0% with standard treatment, in an interim analysis that showed a hazard ratio of 0.48. However, the prespecified efficacy threshold for overall survival was not met at the data cutoff, an important limitation when considering the comparison alongside the response and progression-free survival results. The independent data monitoring committee recommended unblinding the study after the first planned interim efficacy analysis, following the observation of statistical benefit. Standard-treatment options included carfilzomib with dexamethasone, elotuzumab with pomalidomide and dexamethasone, or selinexor with bortezomib and dexamethasone. Investigators selected these regimens for comparison in the study.
Safety data showed differences between the study groups in infection rates by severity. Grade 3 or 4 infections occurred in 27.7% of etentamig recipients, compared with 19.2% with standard treatment, while grade 5 infections were less frequent with the drug, at 1.5%, compared with 3.1%. After the single step-up dose, cytokine release syndrome occurred in 28.3%; most cases were Grade 1, at 23.9%, and no cases of Grade 3 or higher were reported. One case of immune effector cell-associated neurotoxicity syndrome was also reported, Grade 1, at 0.9%. Adverse event-related treatment discontinuations were 3.6% with etentamig, compared with 9.6% with standard treatment.
AbbVie described etentamig as a BCMA- and CD3-targeting bispecific antibody administered once every four weeks after a single step-up dose. This schedule is part of the drug's development context, alongside the efficacy and safety results announced by the company. In its CERVINO results statement, the company said it planned to discuss the findings with global regulators to determine the drug's next steps. The full results were scheduled for presentation in a plenary session at the International Myeloma Society meeting on September 25, 2026; that date preceded the current licensing application announcement. In AbbVie trading, the company's shares closed at $286.74 on October 26, 2026, compared with a close of $285.64 on October 23, according to EL7 data.