Investigational Therapy Extends Progression-Free Survival in Multiple Myeloma


Phase 3 trial evaluating isatuximab in combination with standard of care met the primary endpoint of prolonging progression-free survival.

Treatment with isatuximab in combination with standard of care improved progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma, according to recent data from a phase 3 trial.

There are more than 138,000 new cases of multiple myeloma worldwide each year. However, the disease remains largely incurable in a majority of the patients, representing a need for new therapies.

Isatuximab is an investigational agent that targets a specific epitope of CD38 that is capable of triggering multiple, distinct mechanisms of action believed to promote programmed tumor cell death and immunomodulatory activity. CD38 is a cell surface receptor target for antibody-based therapies in multiple myeloma and other malignancies.

ICARIA-MM was a randomized, multi-center, open label phase 3 study evaluating the benefit of isatuximab in combination with standard-of-care pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone alone. The study was the first to evaluate the benefit of adding a monoclonal antibody to standard of care for this patient population.

A total of 307 patients with relapsed/refractory multiple myeloma were enrolled in the trial across 96 centers spanning 24 countries. Participants received 2 or more prior anti-myeloma therapies, including at least 2 consecutive cycles of lenalidomide and a proteasome inhibitor given alone or in combination. Isatuximab was administered through an intravenous infusion at a dose of 10 mg/kg once weekly for 4 weeks, then every other week for 28-day cycles in combination with standard doses of pomalidomide and dexamethasone for the duration of treatment.

According to the findings, isatuximab in combination with standard of care prolonged PFS compared with pomalidomide plus dexamethasone alone. These results are expected to support regulatory submission later this year, according to Sanofi.

“We are excited by these results, which represent significant progress in our ambition to extend the lives of multiple myeloma patients,” John Reed, head of Research and Development at Sanofi, said in a statement. “We look forward to engaging with regulatory authorities with the goal of bringing this potential new treatment to patients as quickly as possible.”

Isatuximab is currently being evaluated in 4 ongoing phase 3 clinical trials for its use in combination with currently available standard treatments for patients with relapsed/refractory or newly-diagnose multiple myeloma.


Isatuximab Phase 3 trial meets primary endpoint of prolonging progression free survival in patients with relapsed/refractory multiple myeloma [news release]. Sanofi. Accessed February 5, 2019.

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