Johnson & Johnson has submitted a Type II variation application to the European Medicines Agency for an extension of indication for teclistamab in combination with subcutaneous daratumumab for adults with relapsed or refractory multiple myeloma who have received at least one prior therapy.
The company said the two immunotherapies act in a complementary way by targeting BCMA and CD38 to activate the immune system earlier in the treatment pathway. Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson Innovative Medicine, said: “There remains a critical need for off-the-shelf treatment options that can achieve deep and durable responses at second line, when immune function is better preserved.”
She added: “Teclistamab and daratumumab SC is the first off-the-shelf immunotherapy combination to demonstrate significant improvements in progression-free and overall survival in relapsed/refractory multiple myeloma as early as second-line treatment, compared to current standards of care.”
The application is supported by results from the phase 3 MajesTEC-3 study, which enrolled 587 patients. The trial compared teclistamab plus daratumumab SC with daratumumab SC and dexamethasone combined with either pomalidomide or bortezomib.
According to the company, the combination delivered an 83.4 percent reduction in the risk of disease progression or death at nearly three years of follow-up. More than 90 percent of patients who were progression-free at six months remained progression-free at three years. Rates of grade 3 or 4 treatment-emergent adverse events were similar across both study arms, with cytopenia and infection the most common severe events.
Jordan Schecter, Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine, said: “Johnson & Johnson is committed to redefining what’s possible in multiple myeloma. An integral part of this strategy involves using the right medicines as early as possible and combining and sequencing them to achieve the best outcomes.” He added: “Today’s submission to the EMA reinforces this approach.”
The company has also submitted a supplemental Biologics License Application to the US FDA, which has granted Breakthrough Therapy Designation for the combination.
