A Phase 1 First-in-Human Study of TNB-383B, a BCMA x CD3 Bispecific T-Cell Redirecting Antibody, in Patients with Relapsed/Refractory Multiple Myeloma (https://www.myeloma.org/videos/phase-1-first-human-study-tnb-383b-bcma-x-cd3-bispecific-t-cell-redirecting-antibody)
Prognosis is poor for patients (pts) with relapsed/refractory multiple myeloma (RRMM; median overall survival: less than 1 year), indicating a clear need to identify agents with novel mechanisms of action. B-cell maturation antigen (BCMA) has recently emerged as a novel treatment target for MM due to its highly selective expression in plasma cells. TNB-383B, a BCMA x CD3 T-cell engaging bispecific antibody, was designed to overcome the toxicity limitations of existing BCMA therapies and has demonstrated promising results in an ongoing first-in-human phase 1 study in pts with RRMM . Herein, we report the updated efficacy and safety outcomes of this phase 1 study.
Conclusions
TNB-383B in pts with RRMM is well tolerated with an ORR of 79% observed at doses greater than or equal to 40 mg in the dose-escalation cohorts. Despite having a shorter follow-up period, this trend was also observed at doses greater than or equal to 40 mg in the combined dose-escalation/expansion cohorts (ORR: 64%). Enrollment into the dose-expansion arm is ongoing; updated data will be presented at the meeting.
ASH 2021: Abstract 900 (https://ash.confex.com/ash/2021/webprogram/Paper150757.html)