Developer seeks US approval of next-gen med for hard-to-treat myeloma

Abbvie is asking the U.S. Food and Drug Administration (FDA) to approve its next-generation therapy etentamig for people with multiple myeloma whose cancer has relapsed (returned) or failed to respond — when it’s then called refractory — following prior treatments.

The U.S.-based developer announced that it’s submitted an application to the FDA seeking the drug’s approval — a move that follows clinical trial findings from earlier this year that showed both strong response rates and progression-free survival among participants.

The company noted that, even with treatment advancements in recent years, infections and toxicity have proven to be serious issues for people with myeloma. Abbvie says its second-generation therapy may “address the biology of the disease” and “help support effective treatment delivery across diverse care environments” for individuals with this blood cancer.

“This milestone brings us a step closer to potentially delivering a novel, patient-centered treatment option with a manageable safety profile and the convenience of a monthly dosing schedule that can help meet the needs of people living with multiple myeloma wherever they receive care,” Daejin Abidoye, MD, Abbvie’s vice president and therapeutic area head for oncology, solid tumor and hematology, said in a company press release.

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In people with myeloma, plasma cells — a type of immune cell — grow out of control in the bone marrow. A range of treatments are available, but it’s common for myeloma to not respond or come back after an initial round of therapy.

“Multiple myeloma is a chronic blood cancer that can reshape a person’s life,” Abidoye said. “Patients deserve therapeutic options that are not only effective, but also support the realities of when, where and how they receive treatment.”

A long-lasting drug, etentamig can be given monthly

Etentamig belongs to a class of anticancer therapies called bispecific T-cell engagers. The therapy works by simultaneously binding to BCMA, a protein produced by plasma cells, and CD3, a protein found at the surface of a type of immune cell, known as T-cells, that can kill other cells.

By sticking to both proteins at the same time, etentamig is designed to help T-cells more effectively eliminate cancer cells. As a next-generation bispecific T-cell engager, the therapy is designed to help reduce the risk of cytokine release syndrome (CRS), a potentially serious immune reaction that can occur with this and other types of immunotherapies.

Etentamig, given in most clinical trials by infusion into the bloodstream, also stays active in the body longer, allowing for once-monthly dosing. Abbvie says that treatment schedule makes the drug well-suited for use in community-based care.

The application seeking the therapy’s approval was based on data from an ongoing, late-stage clinical trial CERVINO (NCT06158841). The Phase 3 study enrolled approximately 400 adults with relapsed or refractory myeloma who had received at least two previous lines of treatment. The participants were randomly assigned to receive either etentamig or their doctor’s choice of several standard treatment regimens.

The results showed that about three-quarters of patients given etentamig had a treatment response, basically meaning their cancer burden decreased after receiving the therapy. By contrast, fewer than half (46%) of participants given standard-of-care treatment had a response. This difference was statistically significant, meaning it’s unlikely to be due to chance, per the developer.

In addition, the risk of disease progression or death was significantly lower, by 60%, with etentamig relative to standard of care.

The most common safety issues reported among those given etentamig were low antibody levels and low counts of red blood cells and of neutrophils, a type of immune cell. The CRS rate was low with etentamig, reported in slightly more than one-quarter of patients, and mostly mild. There were no severe cases of CRS.

Severe or life-threatening infections were reported at higher rates in patients given etentamig than standard of care (28% vs. 19%), but fatal infections were less common with etentamig (1.5% vs. 3.1%).