AbbVie Seeks FDA Review of Etentamig for Relapsed or Refractory Myeloma

AbbVie announced Oct. 27 it had filed a biologics license application seeking a U.S. Food and Drug Administration (FDA) review for etentamig, an investigational therapy for adults with relapsed or refractory multiple myeloma.

The Phase 3 CERVINO trial used a 1:1 randomization for 393 patients assigned to etentamig or standard therapy selected by investigators. Participants had disease exposed to three treatment classes and had received at least two prior lines of therapy.

At the 11.4-month median follow-up, 74.0% of patients receiving etentamig had an overall response, compared with 45.7% receiving standard therapy. The progression-free survival hazard ratio was 0.40 (95% CI, 0.29 to 0.54; P<0.0001), corresponding to a 60% lower hazard of progression or death in the etentamig group.

Etentamig is an intravenous bispecific antibody designed to bind BCMA and CD3 while engaging T cells. It was administered monthly after one step-up dose. The comparison regimens were carfilzomib plus dexamethasone; elotuzumab with pomalidomide and dexamethasone; or selinexor with bortezomib and dexamethasone.

Pfizer also announced Oct. 27 that Elrexfio met its primary endpoint in a Phase 3 trial after at least one prior treatment line. Etentamig remains investigational.