Johnson & Johnson files EMA extension for TECVAYLI (teclistamab) for RRMM after ≥1 prior therapy
- Type II variation submitted to the EMA to extend TECVAYLI (teclistamab) monotherapy to adult RRMM patients after ≥1 prior therapy.
- Submission supported by Phase 3 MajesTEC-9 in 614 patients showing PFS HR 0.29 (71% reduction) and OS HR 0.60 (40% reduction) versus PVd or Kd.
- Study population was predominantly refractory to anti‑CD38 antibodies (85%) and lenalidomide (79%), with >90% refractory to last line of therapy.
- Safety described as clinically manageable with no new signals; infections addressed via monitoring, immunoglobulin therapy and antimicrobial prophylaxis.
Regulatory filing
Johnson & Johnson has submitted a Type II variation application to the European Medicines Agency seeking an indication extension for TECVAYLI (teclistamab) as monotherapy to treat adult patients with relapsed/refractory multiple myeloma who have received at least one prior therapy.
Clinical evidence
The submission is supported by data from the Phase 3 MajesTEC-9 trial (NCT05572515), a randomised study of teclistamab versus standard of care (pomalidomide, bortezomib and dexamethasone or carfilzomib and dexamethasone) in 614 RRMM patients. Results reported a 71% reduction in risk of disease progression or death (PFS HR 0.29; 95% CI 0.23–0.38) and a 40% reduction in risk of death (OS HR 0.60; 95% CI 0.43–0.83) in a population largely refractory to anti‑CD38 antibodies and lenalidomide.
Safety and monitoring
Teclistamab’s safety profile in MajesTEC-9 was described as clinically manageable and consistent with its known profile, with no new safety signals identified. The company notes infections can be managed with infection-management protocols including monitoring, immunoglobulin therapy and antimicrobial prophylaxis. The Independent Data Monitoring Committee recommended unblinding after the first pre-specified interim analysis.
Product and programme context
Teclistamab is an off-the-shelf bispecific antibody (BCMA×CD3) administered subcutaneously. The European Commission previously approved teclistamab in August 2022 for patients with ≥3 prior therapies and in August 2023 approved a reduced dosing frequency option after sustained complete response. Full MajesTEC-9 results will be presented at a future major medical meeting.
Source: J&J
