Johnson & Johnson has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of an indication extension for TECVAYLI (teclistamab) in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.
Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody administered as a subcutaneous injection. It works by redirecting T-cells through dual targets — BCMA and CD3 — to activate the body’s immune system to fight cancer. Teclistamab is also being investigated in several combination studies.
According to the company, teclistamab and daratumumab work through complementary mechanisms, engaging multiple tumour and immune directed pathways. Daratumumab helps create a more favourable immune microenvironment while enhancing T-cell activation, strengthening teclistamab’s ability to destroy myeloma cells. The approach aims to improve patient outcomes by introducing immunotherapies at an earlier stage, when patients’ immune systems may be better able to respond.
Ester in’t Groen, EMEA Therapeutic Area Head, Haematology at Johnson & Johnson, said the CHMP opinion could help establish the off-the-shelf immunotherapy combination of teclistamab plus daratumumab as a new standard of care earlier in the treatment pathway for multiple myeloma.
Yusri Elsayed, Global Therapeutic Area Head, Oncology at Johnson & Johnson, said the company continues to focus on advancing combination-based immunotherapy approaches to improve patient care.
“By advancing innovative immunotherapies such as teclistamab and combining them with a well-established standard of care like daratumumab, we are building on our deep scientific expertise to deliver more integrated, combination-based approaches that can continue to raise expectations for patient care,” Elsayed said.
Study Results
The recommendation is supported by data from the Phase 3 MajesTEC-3 study, which assessed the efficacy and safety of teclistamab plus daratumumab subcutaneous (SC) formulation versus the investigator’s choice of daratumumab SC and dexamethasone combined with either pomalidomide or bortezomib (DPd/DVd) in patients who have received one to three prior lines of therapy.
After nearly three years of follow-up, results showed over 83 per cent reduction in the risk of disease progression or death among patients treated with the teclistamab-daratumumab combination compared with standard treatment.
More than 90 per cent of patients who remained progression-free at six months continued to remain progression-free at three years, indicating sustained disease control. The safety profile of the combination was reported to be consistent with the known profiles of both medicines.
Teclistamab received European Commission (EC) approval in August 2022 for adults with relapsed or refractory multiple myeloma who had received at least three prior therapies, including an immunomodulatory agent, proteasome inhibitor and anti-CD38 antibody, and whose disease had progressed on their last treatment. In 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5mg/kg every two weeks for patients achieving a complete response for at least six months.
Multiple Myeloma: Signs and Symptoms
Multiple myeloma is a blood cancer affecting plasma cells in the bone marrow. As abnormal plasma cells multiply, they crowd out healthy blood cells and can lead to bone damage and other complications. Signs and symptoms may include bone pain or fracture, fatigue, anaemia, elevated calcium levels, infections and kidney problems.
