Sarclisa under FDA priority review as first-line myeloma therapy

A similar application is under review in the EU

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by Andrea Lobo |

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The U.S. Food and Drug Administration (FDA) has granted priority review to Sanofi’s application of Sarclisa (isatuximab) in combination with standard of care for treating people newly diagnosed with multiple myeloma who aren’t eligible for a transplant.

Priority review is given to therapies that target serious medical conditions that outperform current treatments to make them available faster. The designation should shorten the regulatory review process to six months from the standard 10 months. A decision is expected in September. A similar application is under review in the European Union (EU).

If approved, Sarclisa would become the first anti-CD38 therapy, given along standard of care, for people with newly diagnosed, transplant-ineligible multiple myeloma, and the third indication of Sarclisa for multiple myeloma.

“The filing acceptances, as well as the FDA’s priority review designation, reinforce our confidence in Sarclisa as a potential best-in-class treatment and represent a critical step toward advancing this combination in a difficult-to-treat cancer,” Dietmar Berger, MD, PhD, Sanofi’s chief medical officer and global head of development, said in a company press release. “Despite recent advancements in multiple myeloma treatment, there remains a significant unmet need for new frontline therapies, particularly for transplant-ineligible patients who can face poor outcomes from the disease.”

Multiple myeloma is a form of blood cancer caused by the excessive production of defective plasma cells, a type of white blood cell that produces antibodies, in the tissue inside bones where blood cells are produced, or bone marrow.

Administered directly into the bloodstream, Sarclisa is an antibody-based therapy that targets the CD38 protein, which is found at high levels in myeloma cells, triggering their death.

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What prompted FDA’s priority review of Sarclisa?

The treatment is approved in the U.S. and EU in combination with Pomalyst (pomalidomide) and dexamethasone for adults with relapsed refractory multiple myeloma (RRMM) who failed to respond to at least two prior lines of therapy, including Revlimid (lenalidomide) and a proteasome inhibitor.

It’s also approved in combination with Kyprolis (carfilzomib) and dexamethasone in several countries, including the U.S., for RRMM patients who’ve received between one and three lines of therapy, and in the EU for patients who received at least one prior therapy.

The agency’s decision to grant priority review for the potential new indication was based on results from the Phase 3 IMRIOZ clinical trial (NCT03319667), which enrolled 446 adults across 21 countries with newly diagnosed multiple myeloma who were ineligible for standard autologous stem cell transplant due to old age or coexistent conditions.

The patients were randomly assigned to either Sarclisa (10 mg/kg), given with a combination of Velcade (bortezomib), Revlimid, and dexamethasone (known as VRd), or VRd treatment alone. The treatment was given until disease progression, an unacceptable safety profile, or a decision by the patient to stop it.

At a planned interim analysis, the study was found to have met its main goal of showing that the Sarclisa-VRd combo was significantly superior to standard VRd treatment at prolonging progression-free survival (PFS), that is, the time a patient lived without signs of disease progression.

Detailed trial data will be shared in an oral presentation at the 2024 American Society of Clinical Oncology Annual Meeting, which is starting this week in Chicago and online. The presentation will be titled “Phase 3 study results of isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) versus VRd for transplant-ineligible patients with newly diagnosed multiple myeloma (IMROZ).”

According to its abstract, at a median follow-up of 59.7 months, or nearly five years, median PFS hadn’t been reached in the Sarclisa-VRd group, meaning most patients hadn’t yet shown signs of disease progression. The standard care had a median PFS of 54.3 months, or about 4.5 years.

This indicated the Sarclisa-VRd combo was associated with a 40.4% lower risk of disease progression or death. Based on observed trends so far, median PFS for patients on this combo should reach 90 months, or about 7.5 years, according to the researchers.

Findings of key secondary goals will also be presented, including response rates and overall survival.

The safety and tolerability of the Sarclisa-VRd combo have so far been consistent with the established individual profile of Sarclisa and VRd.

The trial is expected to be completed in 2027.