Investigational combination of first-in-class bispecifics TALVEY® and TECVAYLI® shows deep and durable responses in heavily pretreated multiple myeloma patients with extramedullary disease

Group 1 - The Phase 2 RedirecTT-1 study results show a high overall response rate (ORR) of 78.9% in patients with triple-class exposed relapsed/refractory multiple myeloma (RRMM) who have extramedullary disease (EMD) [1][2][3] - The investigational combination of TALVEY® (talquetamab-tgvs) and TECVAYLI® (teclistamab-cqyv) demonstrates deep and durable responses, with 54.4% of patients achieving complete response or better [2][3][4] - The study enrolled 90 patients, with 84.4% being triple-class refractory and 35.6% penta-drug refractory, indicating a heavily pre-treated population [2][3][4] Group 2 - The combination therapy resulted in 61% of patients being progression-free and alive at one year, with a median follow-up of 13.4 months [2][3][4] - Among responders, 66.2% maintained their response, with a median duration of response of 13.8 months [2][3][4] - The safety profile of the combination was consistent with previous reports, with low rates of discontinuation due to adverse events [2][3][4] Group 3 - TALVEY® received FDA approval in August 2023 as a first-in-class GPRC5D-targeting bispecific antibody for RRMM patients who have received at least four prior lines of therapy [3][4] - TECVAYLI® was approved in October 2022 as an off-the-shelf antibody for RRMM patients who have received at least four prior lines of therapy [5][6] - Both TALVEY® and TECVAYLI® have transformed treatment options for relapsed or refractory multiple myeloma, addressing significant unmet needs in this patient population [2][3][5]