Johnson & Johnson (J&J) has received a positive recommendation from the UK’s National Institute for Health and Care Excellence (NICE) for TALVEY (talquetamab), for use within the NHS in England and Wales as a treatment option for relapsed and refractory multiple myeloma (RRMM).
Multiple myeloma is an incurable blood cancer affecting plasma cells in the bone marrow. When these cells become malignant, they proliferate rapidly and replace healthy cells, forming tumours. Approximately 6,200 new cases are diagnosed in the UK each year, and an estimated 33,000 people are currently living with the disease.
Symptoms may include bone pain, recurrent infections, fatigue, peripheral neuropathy, hypercalcaemia and renal impairment. There remains a significant unmet need, particularly for patients who are heavily pre-treated, as the risk of relapse increases with each successive line of therapy.
TALVEY is a bispecific antibody designed to bind to both myeloma cells and T cells. By redirecting T cells to the myeloma cells, the therapy activates an immune response that results in targeted tumour cell death.
Under the final draft guidance, TALVEY may now be offered as a monotherapy for adults with RRMM following three or more lines of prior treatment, including an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody, where the disease has progressed on the most recent therapy.
NICE’s recommendation is supported by data from the single-arm, open-label phase 1/2 MonumenTAL-1 study, which met both primary and secondary endpoints, demonstrating clinically meaningful responses across overall response rate, progression-free survival and overall survival.
“Given the relapsing and remitting nature of multiple myeloma, patients can face a challenging care journey,” said Amanda Cunnington, UK Senior Director of Patient Access, Johnson & Johnson Innovative Medicine.
“People with myeloma need access to as many treatments as possible at every stage of their disease, and this is especially important at the later stages when options are more limited.
“ Targeted medicines have the potential to help us get in front of cancer by delivering improved outcomes for patients versus standard of care therapies, and we look forward to today’s decision translating into uptake throughout England and Wales.”