NICE approves next-gen treatment Talquetamab
Hundreds of people at fourth line in England and Wales can now access next-generation bispecific antibody, talquetamab (Talvey®).
The treatment targets myeloma in a new way compared to currently available bispecific antibodies and has been shown to deliver remission times of over 11 months.
Talquetamab can also be given fortnightly which offers more flexibility and respite between doses.
Up to 800 myeloma patients are expected to benefit from the new life-extending drug each year on the NHS in England and Wales.
NICE recommended talquetamab for myeloma patients who have had at least three previous treatments including an immunomodulatory agent such as lenalidomide (Revlimid®), a proteosome inhibitor such as bortezomib (Velcade®) and an anti-CD38 antibody like daratumumab (Darzalex®).
The treatment was initially not recommended by NICE because the committee felt that the data presented at the first meeting was too uncertain and that more data was needed to confirm cost-effectiveness.
Myeloma UK submitted more data and evidence to NICE’s appraisal committee and, along with clinicians and the pharmaceutical company behind the treatment, successfully made the case for talquetamab to be rolled out on the NHS.
Shelagh McKinlay, Director of Research and Advocacy, said:
“We’ve been making the case for this treatment to be approved for months and we couldn’t be happier to see it rolled out on the NHS in England and Wales.
“Talquetamab offers more flexibility and leads to a better quality of life. Its unique mechanism of action means it can fight myeloma in a completely different way to other currently available bispecific treatments. This is key because, as people live longer with myeloma, they gradually become resistant to existing drugs.
“This is a hard-earned victory for patients in England and Wales but there’s more work to be done and we will keep pushing for talquetamab to be approved in the rest of the UK. Until we have a cure, it is absolutely vital that people with myeloma are given as many options as possible to keep their disease under control, no matter where they live.”
Talquetamab was licenced in the UK based on results from the phase 1-2 MonumenTAL-1 trial. According to the latest data, around 70% of patients on talquetamab responded to treatment with almost 60% having a very good partial response, or better. The most common adverse events were cytokine release syndrome, taste changes, and infections. New data from the trial was shared as part of the appraisal and reported a median progression-free survival (PFS) of 11.2 months.
In the NICE appraisal talquetamab was compared to teclistamab (Tecvayli®) and the results from the indirect comparison presented suggest that talquetamab increases how long people live compared with teclistamab. Real-world evidence reviewed as part of the appraisal also supported this. The overall survival benefit was attributed to talquetamab’s unique targeting mechanism and the reduction in the number of infections patients experience.
Sue Harley, from Birmingham, was 54 when she was diagnosed with myeloma in 2017 after two years of increasingly debilitating back pain.
Her symptoms had initially been dismissed as osteoarthritis and old age and later misdiagnosed as metastatic breast cancer. By the time her cancer was finally caught she had lesions in her spine and there was clear evidence of old rib fractures.
Over the next six years, the grandmother-of-two received five treatments, including DVT, DT-PACE, and CAR-T cell therapy, but none managed to keep her cancer at bay for long.
That is, until she was offered talquetamab through a compassionate use scheme in September 2023.
Two years on, Sue is still in remission – her longest to date – and credits the drug for giving her her life back.
“It has absolutely given me my life back,” said Sue, now 63. “This is my longest remission. I’d come very close to two years after CAR-T but I relapsed in 2023. I feel fit and healthy, I’ve run two half-marathons since I’ve been on talquetamab. I go to the gym, I go for lunch, I’m in two book groups and I volunteer for a charity once a week. I look after my grandchildren – they’re a joy.
“My granddaughter is five and she started school this year and my grandson is just over six months old. When I was diagnosed, I didn’t know if I would live to see grandchildren, let alone live to see them grow up.
“It’s really good news. As patients all we want is to have options, to have a future ahead of us. This treatment is really manageable. It gives people a chance to live their lives, just like everybody else, to do normal things as well as exceptional things, if they want to.”
Q&A
What does this decision mean for people with myeloma?
The approval means eligible myeloma patients in England and Wales can now access to talquetamab on the NHS.
It gives patients whose myeloma has become resistant to previous myeloma treatments access to an innovative treatment which targets myeloma cells in a new way.
Who can access talquetamab?
Patients at fourth line and beyond who have previously been treated with an immunomodulatory drug, a proteosome inhibitor and an anti-CD38 monoclonal antibody can now receive talquetamab.
What is talquetamab?
Talquetamab is a new type of immunotherapy drug called a bispecific antibody.
It works by helping your T cells (a type of immune cell) find and kill myeloma cells.
Talquetamab attaches to a protein found on the surface of myeloma cells called GPRC5D and a protein found on the surface of T cells called CD3, forming a link between myeloma cells and the T cell.
It is the only available myeloma treatment that targets myeloma in this way.
What about patients in Scotland, Wales and Northern Ireland?
In Scotland, the Scottish Medicines Consortium (SMC) makes decisions about which treatments to fund through the NHS. We hope the SMC appraisal for talquetamab will start early next year.
In Northern Ireland, the Department for Health makes decisions on which treatments to fund through the NHS. They typically accept the guidance issued by NICE, approving the use of the treatment shortly after publication of a positive final decision.
When will talquetamab be available on the NHS?
A positive recommendation from NICE means clinicians can start prescribing the treatment to eligible patients. However, it may take some time for the treatment to become available. This depends on the treatment and hospitals’ capacity to deliver it.
The treatment should be made available to patients through the NHS within 90 days of the publication of the final decision.
Useful resources
- Myeloma Nurse Guide – Bispecific antibodies
- NICE Guidance: Talquetamab for treating relapsed or refractory multiple myeloma after 3 treatments
- MHRA: Talquetamab summary of product characteristics (SPC)
- MHRA: Talquetamab patient information leaflet (PIL)
- Digital Infosession: BCMA and GPRC5D antibodies in practice: Implementation and management for healthcare professionals
