Immuno-Oncology Resource Center

Immuno-Oncology Resource Center

May 19, 2020
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Regimen extends PFS in relapsed multiple myeloma

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The addition of isatuximab-irfc to carfilzomib and dexamethasone significantly prolonged PFS among patients with relapsed multiple myeloma, according to topline data released by the agent’s manufacturer.

Isatuximab-irfc (Sarclisa, Sanofi) is an IV-administered monoclonal antibody that binds to a specific epitope on the CD38 receptor on the surface of multiple myeloma cells.

The agent is approved in the United States for use in combination with pomalidomide (Pomalyst, Celgene) and dexamethasone for treatment of adults with relapsed or refractory multiple myeloma who received at least two prior therapies, including lenalidomide (Revlimid, Celgene) and a proteasome inhibitor.

The randomized phase 3 IKEMA trial included 302 patients with relapsed multiple myeloma who received one to three prior anti-myeloma therapies.

Researchers assigned patients to carfilzomib (Kyprolis, Amgen) twice weekly — with a starting dose of 20 mg/m2 and target dose of 56 mg/m2 — and standard dexamethasone with or without isatuximab-irfc. Isatuximab-irfc was administered via IV infusion at a dose of 10 mg/kg once weekly for 4 weeks, followed by every other week for 28-day cycles.

PFS served as the primary endpoint. Secondary endpoints included overall response rate, rate of very good partial response or greater, minimal residual disease, complete response rate, OS and safety.

The independent data monitoring committee recommended results be released early due to the significant reduction in risk for disease progression or death among patients assigned isatuximab-irfc.

Researchers observed no new safety signals.

Complete results will be submitted for presentation at a medical meeting and also will serve as the basis for regulatory submissions later this year, according to a Sanofi-issued press release.