Under-the-skin myeloma therapy shows strong responses in Phase 2 trial
Study found 88% had a very good partial response or better at 8 months
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A Phase 2 trial of a four-drug regimen including Sarclisa Escena (isatuximab-irfc) showed promising treatment responses in people ages 65 and older with newly diagnosed myeloma who were not eligible for a stem cell transplant. An estimated 93.1% of patients were alive without disease progression at 14 months, and the safety findings were consistent with the regimen’s known profile.
Findings from the investigator-initiated trial, called ISASOCUT (NCT05889221), helped support the U.S. approval of Sarclisa Escena earlier this year. Full results have now been published in Blood Cancer Journal in a paper titled “Subcutaneous isatuximab by on-body-injector plus bortezomib, lenalidomide, and dexamethasone in newly diagnosed transplant-ineligible multiple myeloma: ISASOCUT study.” The study was funded by Sanofi, which develops the therapy.
Under-the-skin treatment offers another option for myeloma
Myeloma is a form of blood cancer in which plasma cells, a type of immune cell, grow out of control in the bone marrow. A stem cell transplant can help some patients achieve long-term remission, but the treatment is intensive, and many people with myeloma are not eligible for it.
Sarclisa Escena is an antibody-based treatment that targets CD38, a protein found on myeloma cells. It is injected under the skin using either an on-body injector or a syringe and infusion set. Sarclisa Escena contains the same active drug as Sarclisa, which is given through an infusion into a vein.
Sarclisa is used with Velcade (bortezomib), Revlimid (lenalidomide), and the corticosteroid dexamethasone as a standard treatment for newly diagnosed myeloma patients who are not eligible for a stem cell transplant. In ISASOCUT, researchers evaluated the safety and effectiveness of this four-drug combination using the under-the-skin formulation, Sarclisa Escena, instead of intravenous Sarclisa. The study was sponsored by the Centre Hospitalier Universitaire of Poitiers in France.
The study included 74 patients, all of whom received the four-drug regimen with Sarclisa Escena delivered through an on-body injector. The median age was 73.
After eight months, 88% of patients had a very good partial response or better, indicating a substantial response to treatment. Roughly one-third of participants achieved minimal residual disease (MRD) negativity, meaning tests found no remaining myeloma cells at the level they could detect.
Most patients remain free of disease progression at 14 months
The median total follow-up time was just shy of two years. As of the latest follow-up, four participants in the study had experienced disease progression, and five had died. The estimated progression-free survival rate at 14 months was 93.1%, meaning that an estimated 93.1% of patients were alive without disease progression at that time.
Safety data from the study showed that 92% of patients experienced severe adverse events, mainly involving low blood cell counts. The researchers said the safety findings were consistent with the known profile of the four-drug regimen. The researchers also noted that reactions at the injection site occurred in 30% of patients and were mostly mild, while infusion-related reactions were uncommon, occurring in 5%.
Overall, the results were consistent with earlier studies using intravenous Sarclisa, suggesting that Sarclisa Escena may offer similar treatment benefits with a more convenient way to administer the drug. However, ISASOCUT did not directly compare the two formulations.
“ISASOCUT met its primary endpoint and supports [Sarclisa Escena administered by an on-body injector] as a feasible alternative to intravenous administration,” the team concluded.
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