The National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance recommending talquetamab for use in the NHS across England and Wales. The bispecific antibody, marketed as Talvey, is indicated for adults with relapsed and refractory multiple myeloma (RRMM) who have received three or more prior lines of therapy, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.

Multiple myeloma is an incurable blood cancer, and most patients will experience relapse and require subsequent therapy. Relapses are more common with each treatment line, creating high unmet need among heavily pre-treated patients. The disease also has a significant psychological impact on patients and caregivers.

Shelagh McKinlay, director of research and advocacy at Myeloma UK, said: “We’ve spent months advocating for this treatment to be approved, and we couldn’t be happier to see it rolled out on the NHS in England and Wales. Talquetamab offers patients an alternative treatment option that could enable better tailoring to their needs compared to standard treatments. This is a hard-earned victory for patients in England and Wales, but there’s more work to be done. We will keep pushing for talquetamab to be approved in the rest of the UK. Until we have a cure, it is vital that people with myeloma have as many options as possible to keep their disease under control, no matter where they live.”

Talquetamab is a first-in-class bispecific antibody that binds GPRC5D on myeloma cells and CD3 on T-cells, activating T-cells to attack the cancer cells. GPRC5D is highly expressed in multiple myeloma, making it a strong additional therapeutic target.

Amanda Cunnington, UK senior director of patient access at Johnson & Johnson Innovative Medicine, said: “Given the relapsing and remitting nature of multiple myeloma, patients can face a challenging care journey. 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. We are delighted to be able to address this treatment need and provide an additional therapy option with a unique target for those eligible on the NHS. 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.”

The efficacy and safety of talquetamab were evaluated in the Phase 1/2 MonumenTAL-1 trial. Patients treated weekly at 0.4 mg/kg achieved an overall response rate (ORR) of 74.1%, with 51.5% maintaining response for at least nine months. Patients treated biweekly at 0.8 mg/kg achieved an ORR of 71.7%, with 76.3% maintaining response for at least nine months. Common adverse events included cytokine release syndrome, dysgeusia, hypogammaglobulinemia, nail disorders, musculoskeletal pain, anaemia, fatigue, weight loss, rash, and neutropenia. Treatment discontinuation due to adverse reactions was low, with immune effector cell-associated neurotoxicity syndrome (ICANS) occurring in 1.1% of patients.