28th June 2022 // Kat McGregor
Recently, there have been a lot of news stories about a new preventative COVID-19 treatment called Evusheld. As a result, people in the myeloma community are asking us questions about Evusheld and whether it will be suitable for myeloma patients.
Evusheld is a treatment that can help protect people with low immune systems against COVID-19.
It is a combination of two monoclonal antibody drugs called tixagevimab and cilgavimab. The drugs work by mimicking the antibodies your body would naturally produce in response to COVID-19 or a COVID-19 vaccine.
This means Evusheld can be used to protect patients who don’t respond to COVID-19 vaccines by giving people who can’t naturally produce antibodies a dose of synthetic antibodies to help them prevent infection.
The data to support its use comes from the global phase 3 PROVENT trial, which assessed its effectiveness in a range of non-vaccinated, clinically high-risk, or immunosuppressed patients.
The PROVENT trial shows that Evusheld has protective properties in this group of patients, reducing the risk of developing symptomatic COVID-19 by 77%. Furthermore, no one on the trial who received Evusheld became seriously ill from COVID-19, and people tolerated the treatment well.
It is for this reason that the Medicines & Healthcare products Regulatory Agency (MHRA) approved Evusheld as a protective treatment for people who are unlikely to mount an adequate immune response to COVID-19 vaccination or for whom COVID-19 vaccination is not recommended.
So why is Evusheld not available through the NHS and will myeloma patients get it?
Before a patient receives any treatment, we need to be confident that it will have a benefit. While the data from PROVENT confirms Evusheld’s protective capabilities, several questions need to be answered to confirm the benefit it would give to myeloma patients in the UK today.
The first question is whether Evusheld prevents the Omicron variant of COVID-19. Researchers collected data from the PROVENT trial before the Omicron variant emerged. Therefore, the PROVENT trial can’t tell us how well Evusheld protects people from today’s variants.
The second question is what constitutes an adequate immune response to COVID-19 vaccination, and how do we determine which “vaccinated” patients would get added protection from Evusheld. The PROVENT trial did not include anyone who had received any doses of the COVID-19 vaccine, and although there is newer data in vaccinated people, there is currently no data in patients who have received five doses as immunocompromised people in the UK have. Thus, we know that people with no antibodies benefit but can’t confirm how much it will benefit those who produce a low level of antibodies. It also doesn’t tell us whether Evusheld would provide the same level of protection as a booster dose.
Finally, the trial doesn’t tell us how many myeloma patients were included in the trial. Therefore it doesn’t tell us how effective Evusheld is for myeloma patients. When the researchers refer to immunosuppressed people or people with poor immune systems, they are not talking exclusively about myeloma patients or even blood cancer patients. They refer to any person who is listed as immunosuppressed on their electronic patient record. Therefore, the patients in the immunosuppressed group could include cancer patients on treatment, people with HIV or autoimmune diseases, and might not include any myeloma patients.
We do not yet know if or when Evusheld will be made available through the NHS. Nor do we know who will be entitled to the drug, as the COVID-19 Therapeutics Clinical Review Panel are still reviewing the available data assessing the safety and effectiveness of Evusheld.
Approval by the MHRA is only a decision based on the evidence submitted that a drug is considered safe and effective for specific use in a particular group of patients; it does not mean the treatment has been approved for use on the NHS.
We are not sure how people will be selected for this treatment, but the MHRA process approved Evusheld for use in adults unlikely to have an antibody response from COVID-19 vaccines and people who can’t have vaccines.
The PREPARE study revealed that 93% of myeloma patients had an antibody response after receiving just two doses of the COVID-19 vaccine.
From this myeloma-specific vaccine data, myeloma patients may not be eligible for Evusheld as the best protection is continuing COVID-19 vaccines.
The PREPARE study is continuing to monitor antibody response to COVID-19 vaccines and boosters.
It is encouraging to see an increasing number of treatments investigated as contenders to protect clinically high-risk groups from COVID-19. Still, the MHRA approval of Evusheld is unlikely to change things for most myeloma patients.
COVID-19 vaccines remain the best protection against COVID-19. Make sure you keep up to date with your COVID-19 boosters.
If you have symptoms and test positive for COVID-19, you could get COVID-19 treatments to help manage COVID-19 symptoms and reduce the risk of becoming seriously ill.