RedirecTT-1 Trial: Talquetamab + Teclistamab for Multiple Myeloma with Extramedullary Disease

Talquetamab plus teclistamab combination therapy achieved a 79% overall response rate with 52% complete responses in triple-class exposed relapsed/refractory multiple myeloma (RRMM) patients with extramedullary disease (EMD), significantly outperforming historical monotherapy results. This dual bispecific antibody approach represents a new standard for EMD patients, a historically difficult-to-treat population with poor outcomes.

Study Design & Population

Phase 2 RedirecTT-1 EMD cohort (NCT04586426)

  • 90 patients with triple-class exposed RRMM and EMD
  • Median age 65 years, median 4 prior lines of therapy
  • 84% triple-class refractory, 36% pentadrug refractory
  • 20% prior anti-BCMA CAR-T therapy, 9% prior bispecific antibodies
  • EMD defined as ≥1 nonradiated soft tissue plasmacytoma ≥2 cm noncontiguous with bone

Key Findings

  • Overall response rate: 79% (95% CI: 69.0-86.8)
  • Complete response rate: 52%, with 70% achieving ≥VGPR
  • Median progression-free survival: 15.4 months with 1-year PFS of 61%
  • Median duration of response: 13.8 months
  • 1-year overall survival: 74.5%
  • ORR 83% in patients with prior anti-BCMA CAR-T therapy
  • 77.5% of responders successfully switched to monthly dosing schedule

Clinical Implications

  • Combination substantially outperforms monotherapy talquetamab (ORR 43.5%) and teclistamab (ORR 43.4%) in EMD
  • Efficacy comparable to CAR-T therapy outcomes in RRMM with EMD population
  • Monthly dosing schedule feasible for most responders after initial treatment cycles
  • Represents first dual-targeting bispecific approach showing superior outcomes in EMD

Limitations

  • Single-arm study design without direct comparator arm
  • Median follow-up of 12.6 months limits long-term durability assessment
  • Grade 5 adverse events in 11.1% of patients, with half being infections
  • High rate of grade 3/4 neutropenia (62%) and infections (37%)

Source: https://congress-distribution.ehaweb.org/from.storage?image=RZshABASE-rg9u-zI63Z1Kh31X_SKpL5hgyCcld6GAtb-5YSZmaL_aMkZaYR4txQ0

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