Adding isatuximab to a standard of care treatment of Pomalyst (pomalidomide) and low-dose dexamethasone prolonged the time without cancer progression in adults with relapsed or refractory multiple myeloma, according to results of a Phase 3 clinical trial.
“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 isatuximab’s developer Sanofi, said in a press release. “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 an antibody that targets the CD38 protein, a cell surface molecule highly expressed by multiple myeloma cells. After binding to its target, isatuximab not only causes cells to die, but also engages the immune system into fighting these cells.
The randomized Phase 3 trial, called ICARIA-MM (NCT02990338), was designed to investigate if isatuximab could delay disease progression or death among multiple myeloma patients who had failed prior lines of treatment.
The study included 307 patients whose disease had returned (relapsed) or did not respond to two or more prior therapies (refractory), including a minimum of two consecutive cycles of Celgene’s Pomalyst (marketed as Imnovid in Europe) and a proteasome inhibitor given alone or in combination.
A total of 96 centers in 24 countries participated in the Sanofi-sponsored study.
Isatuximab was delivered via intravenous infusion — once weekly in the first four weeks and every other week thereafter — in combination with standard doses of Pomalyst and dexamethasone. Treatment was given until patients experienced disease progression or signs of unacceptable toxicity.
In addition to progression-free survival, researchers also measured the overall response rate, overall survival, and duration of response. The safety profile of the combination therapy was also evaluated.
The findings will be submitted to an upcoming medical meeting and are planned to be the basis of regulatory submissions later this year.
According to Sanofi, ICARIA-MM is the first Phase 3 study combining a monoclonal antibody with Pomalyst and dexamethasone to treat relapsed or refractory multiple myeloma.
Sanofi is conducting other three Phase 3 trials assessing isatuximab in combination with standard treatments for patients with multiple myeloma. While the IKEMA study (NCT03275285) tests the combination in relapsed/refractory disease, the IMROZ (NCT03319667) and the GMMG HD7 (NCT03617731) trials focus on newly-diagnosed patients. All three trials are still enrolling participants. For more information, please click on the links to the studies.
Both the U.S. Food and Drug Administration and the European Medicines Agency granted isatuximab orphan drug designation for the treatment of relapsed or refractory multiple myeloma.