Monday, Johnson & Johnson JNJ announced longer-term data from Phase 1/2 MajesTEC-1 study of Tecvayli (teclistamab-cqyv) showing deep and durable responses in patients with relapsed or refractory multiple myeloma (RRMM).
Results from the MajesTEC-1 study show that, at a median follow-up of 30.4 months, patients treated with Tecvayli at the recommended Phase 2 dose demonstrated an overall response rate (ORR) of 63%, with responses continuing to deepen and 46% of patients achieving a complete response (CR) or better.
For patients with a CR or better, median duration of response (mDOR), median progression-free survival (mPFS), and median overall survival (mOS) were not yet reached, and estimated 30-month DOR, PFS, and OS rates were 61%, 61% and 74%, respectively.
The safety profile remained consistent, with a notable decrease in new onset of severe infections over time.
Extended follow-up of patients from a MajesTEC-1 cohort, investigating the prophylactic use of tocilizumab for the reduction of cytokine release syndrome (CRS) in patients treated with Tecvayli, were also presented at ASCO.
Results show that a single dose of tocilizumab before Tecvayli in patients with RRMM (n=24) reduced the incidence of CRS with a 65% relative reduction versus the overall MajesTEC-1 population.
This approach is continuing to be evaluated in the Phase 2 OPTec study of Tecvayli in the community setting.
Data showed preliminary evidence that prophylactic tocilizumab potentially reduces the incidence of CRS, with no new safety concerns to date, and underscores the opportunity for outpatient administration.
Results from subgroup analysis from the MajesTEC-1 study of Tecvayli investigating patients with high-risk RRMM show that at a median follow-up of 30 months, patients who were aged 75 years or older demonstrated similar efficacy as the overall RP2D population with an ORR of 54%, 61% and 60% and a CR or better rate of 42%, 42%, and 48%, respectively.
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Price Action: JNJ shares are up 0.67% at $147.65 at the last check on Monday.
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