SUMMARY

• Janssen does not recommend any practices, procedures, or usage that deviate from the product labeling or are not approved by the regulatory agencies.
• MajesTEC-9 is an ongoing, phase 3, randomized, open-label, multicenter study comparing TECVAYLI with investigator’s choice of pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with relapsed or refractory multiple myeloma (RRMM) who previously received 1-3 prior lines of therapy (LOT) including an anti-CD38 monoclonal antibody (mAb) and lenalidomide.^1,2
  • The study is currently ongoing, and results are not available yet.

CLINICAL DATA - MajeSTEC-9 Study

MajesTEC-9 (MMY3006; clinicaltrials.gov identifier NCT05572515) is an ongoing, phase 3, randomized, open-label, multicenter study comparing TECVAYLI with investigator’s choice of PVd or Kd in patients with RRMM who previously received 1-3 prior LOT including an anti-CD38 mAb and lenalidomide.^1,2

Study Design/Methods

• The study is expected to enroll ~590 patients. Patients will be randomized 1:1 to receive either TECVAYLI (n=295) or investigator’s choice of PVd or Kd (n=295).²
• The study will include a screening phase, treatment phase, and follow-up phase. The total duration of the study will be up to 9 years.²
• The study design is presented in the figure: MajesTEC-9 Study Design.^1,2
• Key inclusion criteria: ≥18 years old, RRMM per International Myeloma Working Group (IMWG) criteria with evidence of progressive disease or failure to achieve a response to the last LOT, Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2, received 1-3 prior LOT including ≥2 consecutive cycles of an antiCD38 mAb and ≥2 consecutive cycles of lenalidomide.²
• Key exclusion criteria: prior B-cell maturation antigen (BCMA)-directed therapy.²
• Primary endpoint: progression-free survival (PFS) per IMWG criteria.²
• Key secondary and other endpoints: overall response rate (ORR; partial response or better [≥PR]), very good partial response or better (≥VGPR), complete response or better (≥CR), overall survival (OS), progression-free survival on next-line therapy (PFS2), time to next treatment (TTNT), adverse events (incidence and severity), change from baseline in health-related quality of life (HRQoL) outcomes, time to HRQoL improvement and worsening, proportion of patients with meaningful HRQoL improvement, pharmacokinetics (PK) and anti-drug antibodies, and outcomes in highrisk patient subgroups.²

LITERATURE SEARCH

A literature search of Ovid MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 05 June 2024.