AbbVie has announced positive topline results from a phase 3 study evaluating etentamig, an investigational BCMA x CD3 bispecific T-cell engager, versus standard available therapies (SAT) in patients with triple-class exposed (proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody) relapsed/refractory multiple myeloma (RRMM).
The study met its dual primary endpoints of objective response rate (ORR) and progression-free survival (PFS). Full results will be presented in a plenary session at the 23rd International Myeloma Society Annual Meeting, taking place 23-26 September in Glasgow, Scotland.
At the data cutoff, the phase 3 trial included 393 patients who had received a median of three prior lines of therapy. At the median follow-up of 11.4 months, etentamig demonstrated statistically significant and clinically meaningful efficacy with a manageable safety profile.
This was the first planned efficacy interim analysis of the study and based on the significant benefit, the Independent Data Monitoring Committee (IDMC) recommended unblinding the study.
