On January 6, the CDE website showed that AbbVie's clinical trial application for the infusion solution ABBV-383 was accepted, with the indication under development being multiple myeloma.ABBV-383 (TNB-383B) is a bispecific antibody targeting BCMA and CD3 jointly developed by AbbVie and TeneoOne. It employs a 2:1 design, maintaining cytotoxic capacity while reducing cytokine release.In June 2021, AbbVie exercised its option to acquire Teneone and ABBV-383, primarily based on the interim analysis data from the ongoing Phase I clinical trial for relapsed/refractory multiple myeloma (R/R MM) at that time.Interim results from the Phase I study of ABBV-383 showed that in the dose-escalation cohort with a median follow-up time of 6.1 months (n=24), the objective response rate (ORR) for TNB-383B at doses ≥40mg was 79%, with a very good or better partial response rate (≥VGPR) of 63% and a complete response rate (CR) of 29%. The median duration of response (DOR) for patients has not yet been reached.The most common treatment-related adverse events observed across all levels were cytokine release syndrome (CRS) (52%), fatigue (25%), and neutropenia (24%). At a dose of 60mg intravenously every 3 weeks (Q3W), the CRS rate was 67% (all grades), with grade ≥3 CRS occurring at a rate of 3% (1/39 subjects). No grade 4 or higher CRS was observed.Currently, ABBV-383 is undergoing Phase III clinical trials for multiple myeloma abroad. In addition, this product is also being developed for the treatment of AL amyloidosis. Among drugs targeting the same point,, Janssen's Teclistamab has been submitted for marketing approval in China, HuiElranatamab by Rui has advanced to Phase III clinical stage.Copyright © 2024 PHARMCUBE. All Rights Reserved.
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