Johnson & Johnson's Janssen announced that the FDA has granted accelerated approval to Talvey, a first-in-class novel bispecific antibody for heavily treated refractory multiple myeloma.
The approval hinged in the phase 2 study MonumenTAL-1, which enrolled 187 patients who hadn't received T-cell redirection therapy. The study found an overall response rate of more than 70% with durable responses, which included 32 patients previously treated with bispecific antibody or CAR-T therapy.
The drug is Janssen's second bispecific antibody approved for this type of cancer. Last year, the FDA granted accelerated approval to Tecvayli, which was the first bispecific B-cell maturation antigen-directed CD3 T-cell engager approved by the agency.
Talvey is designed to engage the CD3 receptor on T cells and target GPRC5D on multiple myeloma cells, and is administered via subcutaneous injections, allowing for dosing flexibility after an initial phase. Bispecific antibodies stimulate the patient's own T-cells to eliminate their cancer cells and have demonstrated positive outcomes.
Bispecific antibodies stimulate the patient's own T-cells to eliminate their cancer cells and have demonstrated positive outcomes. Other companies like Roche have inked their own deals to tap into their potential. In 2020, Roche signed a $2 billion cancer platform deal with Innovent Biologics to develop and commercialize bispecific antibodies and multiple cell therapies.
These drugs are not without their risks, however. Talvey comes with warnings about cytokine release syndrome and neurological issues. Earlier this year, Regeneron took a step back from one of its CD28 bispecific drug studies following the deaths of two patients.