The National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending elranatamab (Elrexfio) for the treatment of multiple myeloma.
The drug was initially approved in June on the NHS in England and Wales, but patients who had previously received a combination of isatuximab, pomalidomide, and dexamethasone or of pomalidomide plus dexamethasone were not eligible.
NICE has now lifted these restrictions such that elranatamab is recommended for patients with relapsed and refractory multiple myeloma who have received at least three lines of treatment, including an immunomodulatory agent (eg, pomalidomide), a proteasome inhibitor (eg, bortezomib), and an anti-CD38 antibody (eg, isatuximab), and whose cancer has progressed since their last treatment.
Elranatamab is not recommended for routine use in the NHS but can be made available via the Cancer Drugs Fund (CDF) with managed access whilst more evidence is being collected about its effectiveness.
“Multiple myeloma is a difficult to treat, rare, and devastating form of cancer that can be debilitating, painful, and has substantial impact on quality of life,” Helen Knight, director of medicines evaluation at NICE, said in a statement.
Just over 700 people in England will be eligible for the treatment, NICE said. Each year in the United Kingdom, approximately 5900 people are diagnosed with myeloma, according to Myeloma UK .
Caroline Donoghue, senior policy officer at the charity, hailed the announcement as “brilliant news”. “Elranatamab has shown very promising results in clinical trials and allowed some people who have never responded well to treatment to experience their very first complete remission,” she said in a statement.
Effectiveness Remains Uncertain
At present, pomalidomide plus dexamethasone is the main treatment used for multiple myeloma that has relapsed and is refractory after three or more lines of treatment. If this combination is not suitable, panobinostat plus bortezomib and dexamethasone can be used. If the multiple myeloma is refractory to five or more treatments, selinexor plus dexamethasone can be used. Indirect clinical trial comparisons with these treatments suggest elranatamab may increase how long people have before their condition worsens. But further evidence is needed since direct comparisons have not been conducted.
Elranatamab is a bispecific monoclonal antibody that binds to the B cell maturation antigen on plasma cells, plasmablasts, and multiple myeloma cells, as well as to the CD3 receptor on T cells. By attaching to specific multiple myeloma cancer cells and the immune system’s T cells, it brings them together to help the immune system destroy the cancer cells. Since it is administered subcutaneously, either in the abdomen or thigh, treatment may be more convenient for patients than the alternatives.
The key clinical evidence for elranatamab in the NICE assessment came from MagnetisMM-3, a phase 2, nonrandomised, open-label study in people with relapsed and refractory multiple myeloma that is refractory to at least one immunomodulatory drug, one proteasome inhibitor, and one anti-CD38 monoclonal antibody. According to the latest data from the trial, patients’ overall response rate was 61%, while the average remission was 17.2 months.
NICE concluded that the results from this study appear promising but stressed that the data are immature.
Dr Rob Hicks is a retired NHS doctor. A well-known TV and radio broadcaster, he has written three books and has regularly contributed to national newspapers, magazines, and online. He is based in the UK.