• Approval is based on Phase 3 results demonstrating significant progression-free and overall survival benefits, with teclistamab reducing risk of disease progression or death by 71% and risk of death by 40%, compared with the standard of care¹
• Further expands treatment options for relapsed/refractory multiple myeloma, making teclistamab available in the second line setting through both combination and monotherapy approaches^1,2

Johnson & Johnson, a worldwide leader in multiple myeloma, announced that the European Commission (EC) has approved an indication extension of TECVAYLI^® (teclistamab) for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy. Building on the recent EC approval of teclistamab plus daratumumab, this indication extension introduces teclistamab monotherapy as an additional second-line treatment option for patients living with RRMM and reinforces the wider potential of teclistamab across both monotherapy and combination approaches for patients at first relapse.^1,2

Building momentum for teclistamab-based regimens at first relapse
Many patients with multiple myeloma relapse after first-line therapy, and treatment options are increasingly limited once the disease becomes refractory to established treatment classes.^3,4 Despite recent advances, there remains a critical need for additional effective immunotherapy options at first relapse, where treatment decisions can have a meaningful impact on long-term outcomes.^3,4

Expert and company perspectives on expanding treatment options with teclistamab
“Patients with relapsed or refractory multiple myeloma often experience shorter remissions and diminishing responses with each subsequent line of therapy, making effective treatment at first relapse increasingly important,” said Cyrille Touzeau, M.D., Ph.D., Professor, University Hospital of Nantes.* “The approval of teclistamab monotherapy gives physicians an additional immunotherapy option in the second-line setting, supported by significant improvements in both progression-free and overall survival. With nearly two-thirds of patients achieving a complete response or better, the results seen with teclistamab are encouraging and demonstrate the depth of response achieved in the study.”

“Building on the recent approval of teclistamab plus daratumumab, this European Commission further reinforces the strength of bispecific-based immunotherapy approaches as early as second line,” said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “Together, the MajesTEC-3 and MajesTEC-9 studies support the potential of teclistamab-based therapies to advance the treatment paradigm and improve outcomes for patients earlier in their disease journey.”

“Today's approval marks another important step in our ambition to bring innovative immunotherapies earlier in the treatment journey for patients with multiple myeloma,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. “With positive Phase 3 results from both MajesTEC-3 and MajesTEC-9, we continue to build evidence for teclistamab-based regimens across a broad second-line patient population. Together, these studies highlight the potential of teclistamab to become a foundational option at first relapse, while reinforcing our ambition to improve long-term outcomes for patients.”

Phase 3 monotherapy data demonstrated significant survival benefits compared with standard of care, supporting the use of teclistamab in second-line RRMM

The updated label will replace the current monotherapy indication and posology, and introduce a simplified dosing schedule with monthly dosing frequency from month 7 onwards. Eligible patients may also transition to monthly dosing as early as month 3, further optimising the dosing schedule and potentially reducing the treatment burden for patients.

The EC approval is supported by data from the Phase 3 MajesTEC-9 study (NCT05572515), evaluating the efficacy and safety of teclistamab, a bispecific T-cell engager, as a monotherapy versus pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with RRMM who have received one to three prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide.⁵

Significant improvements were observed in both progression-free survival (PFS) and overall survival (OS).¹ Treatment with teclistamab demonstrated a 71% reduction in the risk of disease progression or death (hazard ratio [HR], 0.29; 95% confidence interval [CI], 0.23-0.38; p<0.001) and a 40% reduction in the risk of death (HR, 0.60; 95% CI, 0.43-0.83; p = 0.002) compared with the standard of care.¹ Teclistamab’s 18-month PFS rate was 69.8% versus 26.9% for the standard of care, and the 18-month OS rate was 79.2% with teclistamab versus 68.6% for the standard of care.¹ Additionally, all key secondary endpoints showed significant improvement with teclistamab versus standard of care, including nearly two-thirds of patients achieving a complete response or better (≥CR; 65.9% vs. 16.8%; p<0.001).¹

Safety profile consistent with that established in prior studies

The safety profile for teclistamab in the study was consistent with its known safety profile.^1,6 The median duration of treatment on teclistamab was almost two times longer than standard of care (13.1 months vs. 7.0 months), with similar rates of adverse events (AEs) observed between teclistamab and standard of care (99.7% vs. 97.9%).¹ Grade 3/4 AEs occurred in 84.9% of teclistamab recipients versus 76.3% of PVd or Kd recipients, while Grade 5 AEs occurred in 6.5% versus 3.5%, respectively.¹ Infections were more frequent with teclistamab than with standard of care (Grade 3/4, 41.6% vs. 29.0%), and rates of Grade 3 or higher infections decreased over time.¹