Scientists target high infection rates among myeloma patients in treatment
Study findings underscore need for 'evidenced-based strategies' to cut risk
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Infections affecting nearly three-quarters of people with myeloma taking part in clinical testing for the now-approved treatment Lynozyfic (linvoseltamab-gcpt) sparked evolving “infection protection” strategies in early clinical trials, according to a research team.
Now, that team — more than half of them employed by Regeneron Pharmaceuticals, which markets Lynozyfic — is sharing the results of their analysis of the factors driving those high infection rates, which, the scientists noted, are common with all treatments in this “typically elderly,” high-risk patient population. The researchers noted that “profiling the occurrence of infections and approaches for infection management are critical” for easing the treatment burden among people with hard-to-treat cancer.
Their analysis covered data from more than 100 patients enrolled in the Phase 1/2 LINKER-MM1 clinical trial (NCT03761108), and revealed that the infection risk was highest in the first months after starting Lynozyfic. The findings, the scientists say, underscore the need for careful monitoring and preventive measures to reduce the risk of infections.
Overall, per the team, the study “[highlights] the importance of evidence-based strategies for prevention, monitoring, and management of infections” in individuals with myeloma.
The study, titled “Infection risk and management in patients with relapsed/refractory multiple myeloma treated with linvoseltamab in the LINKER-MM1 study,” was published in Blood Cancer Journal. The work was funded by Regeneron, which employs eight of the study’s 13 authors.
A form of blood cancer, myeloma is marked by the uncontrolled growth of plasma cells, a type of immune cell. People with myeloma often have weakened immune systems due to both the underlying disease and the impacts of treatment. Consequently, infections are a major cause of health problems among myeloma patients.
High infection risk seen with Lynozyfic, other myeloma drugs
Lynozyfic is a type of myeloma therapy known as an anti-BCMA bispecific antibody. It works by sticking to a plasma cell protein called BCMA and, at the same time, sticking to receptors on cancer-killing immune cells called T-cells, which activate the T-cells to kill the plasma cell. In the U.S., Lynozyfic is conditionally approved for certain adults with myeloma that has come back or failed to respond to prior treatments. It’s given by an intravenous infusion, or directly into the bloodstream.
The drug’s approval was based on data from the ongoing LINKER-MM1 trial, which launched in 2019 and will run through 2033. It’s still recruiting participants at certain sites in the U.S., Europe, and Asia.
In this new study, scientists analyzed data from the clinical trial to better understand how infections impacted myeloma patients undergoing Lynozyfic treatment. This was a post hoc analysis, meaning the data used were from completed portions of the trial.
The researchers noted that, “as anti-BCMA bispecific antibodies such as [Lynozyfic] become integral treatment options for [hard-to-treat myeloma], it is important to better characterize infection events and risks to inform data-driven prevention and management strategies.”
Altogether, their analysis covered data from 117 patients treated with the now-approved 200 mg dose of Lynozyfic. The participants’ median age was 70, and slightly more than half were male.
Overall, infections were reported in about three-quarters of those treated, with serious infections affecting nearly half (45%). Respiratory infections and coronavirus were the most common infection types, and the median duration of an infection was about two weeks.
Infections led to delays or interruptions in Lynozyfic treatment for about half of the participants, and nearly 1 in 10 discontinued treatment because of them.
The median time from the start of Lynozyfic to the first infection was slightly more than two months. Importantly, according to the researchers, statistical analyses showed that infections were most common immediately after treatment began. Infection rates dropped considerably after about six months of follow-up.
Closely monitoring infections and taking proactive measures for [infection] prevention and treatment are especially critical in the early months of treatment, considering the proportionately higher risk of infections and greater rate of treatment discontinuation due to infection in this period.
“These data show a trend for reduced infection risk after the first 6 months of treatment, although the risk was not completely eliminated, necessitating continued vigilance and use of anti-infective medications,” the researchers wrote.
Additional analyses indicated that the risk of infection tended to be lower in patients who received immunoglobulin replacement therapy (IgRT) within the first few months of Lynozyfic treatment. IgRT is a type of anti-infective therapy that works by infusing a patient with antibodies that can protect the body from viruses and bacteria. Based on these findings, the researchers advised IgRT as part of infection-preventing measures for patients starting Lynozyfic.
Overall, the scientists noted the importance of “knowledge-based surveillance and management of infections” for people with myeloma undergoing treatment.
“Closely monitoring infections and taking proactive measures for [infection] prevention and treatment are especially critical in the early months of treatment, considering the proportionately higher risk of infections and greater rate of treatment discontinuation due to infection in this period,” the team wrote.
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