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The Scottish Medicines Consortium (SMC) has accepted talquetamab (Talvey, Johnson & Johnson Innovative Medicine) for use within NHS Scotland to treat adults with relapsed and refractory multiple myeloma. 

The recommendation specifically applies to patients who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and whose disease has progressed on their last therapy.

The decision gives eligible patients in Scotland access to a first-in-class, G protein-coupled receptor class 5D (GPRC5D)-targeted bispecific antibody at a point in the treatment pathway when options are limited. 

Addressing an Incurable Disease

Multiple myeloma is a rare haematologic cancer that mainly affects individuals older than 60 years. Despite advances in treatment, it remains incurable, with most patients eventually experiencing relapse as resistance develops. The disease is caused by clonal proliferation of plasma cells in the bone marrow and can lead to complications such as bone pain, anaemia, renal impairment, hypercalcemia, recurrent infections, and neurologic complications. 

Talquetamab is an immunoglobulin G4 bispecific antibody that binds GPRC5D on multiple myeloma cells and the CD3 receptor complex on T cells. By engaging both targets, the drug redirects and activates T cells to kill GPRC5D-expressing myeloma cells.

Clinical Evidence and Dosing

The recommendation was supported by data from the phase 1/2 MonumenTAL-1 study, which evaluated 154 heavily pretreated patients receiving talquetamab at a dosage of 0.8 mg/kg every 2 weeks.

After a median follow-up of 31.2 months, the overall response rate was 70%. Stringent complete response was reported in 31% of patients, and complete response in 9.1%. Median duration of response was 17.5 months, and median progression-free survival was 11.2 months. Median overall survival had not been reached at the time of the September 2024 data cut.

Talvey is administered by subcutaneous injection at a recommended dosage of either 0.4 mg/kg once weekly or 0.8 mg/kg once every 2 weeks. Treatment is preceded by step-up dosing of 0.01 mg/kg on day 1, 0.06 mg/kg on day 3, and 0.4 mg/kg on day 5. For the every-2-weeks schedule, an additional 0.8 mg/kg dose is given on day 7. Treatment continues until disease progression or unacceptable toxicity. 

Safety Profile 

The toxicity profile of talquetamab requires proactive clinical management, particularly during step-up dosing and the first full doses. The most frequently reported adverse events included cytokine release syndrome (75%), non-rash skin-related events (74%), and taste changes (71%). Most cytokine release syndrome events occurred during step-up dosing or after the first full doses, with supportive treatment required in 71% of cases. Grade 3 or 4 haematologic adverse events were generally reversible and limited to the first few treatment cycles.

Patient and Charity Perspective

Myeloma UK welcomed the decision, saying talquetamab targets myeloma differently from currently available treatments and could offer patients greater flexibility. Gabrielle King, senior policy officer at the charity, called the acceptance “fantastic news” and said it could make a “huge difference” for people with myeloma in Scotland.

In evidence submitted to SMC, Myeloma UK said patients need treatments with novel mechanisms of action after previous therapies have failed. Patients who had received talquetamab said its side effects were manageable and that they would recommend it for use on the NHS. SMC also noted that fortnightly subcutaneous dosing was considered an advantage.

Healthcare Impact

Talquetamab was assessed as SMC2863 through a full submission, with additional context from the Cancer Medicines Outcomes Programme-Public Health Scotland report on bispecific antibody treatment for adults with relapsed and refractory multiple myeloma.

The decision represents a significant treatment advance for patients in Scotland who have exhausted multiple prior treatment lines and have limited remaining options. Myeloma UK said approximately 50 patients each year are expected to benefit from talquetamab in Scotland.

The drug will be made available under an approved NHS Scotland Patient Access Scheme, or at an equivalent or lower price.