Isatuximab Combination Therapy Shows Statistically Substantial Improvements compared to pomalidomide and dexamethasone combination.
Sanofi reports that a crucial Phase 3 ICARIA—MM trial results revealing that isatuximab aided dexamethasone and pomalidomide (isatuximab combination therapy) has shown statistically substantial improvements compared to pomalidomide and dexamethasone (pom-dex) alone in patients ensuring relapsed/refractory multiple myeloma (RRMM). The results were presented at the recent ASCO meetings in Chicago.
The primary objective of the study was to demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose dexamethasone in the prolongation of Progression Free-Survival (PFS) as compared to pomalidomide and low-dose dexamethasone in patients with refractor or relapsed and refractory multiple myeloma (MM).
ICARIA-MM was a crucial Phase 3 open-label, randomized, multi-center study assessing isatuximab combined with pom-dex against pom-dex alone in patients enduring RRMM. Around 307 patients suffering from RRMM have been enrolled in the study at around 96 centers in 24 nations. Overall, patients were given a median of 3 prior lines of anti-myeloma treatments which includes minimum 2 sequential cycles of a proteasome inhibitor and lenalidomide given alone or in combination.
During the study, Isatuximab was dispensed via an intravenous infusion at a dose of 10mg/kg once weekly for 4 weeks and further every other week for 28-day cycles combined with pom-dex standard doses for the period of therapy.
Principal Investigator Jerome Lipper reportedly stated that Isatuximab added to pomalidomide and dexamethasone has resulted in remarkable 40% decrease in the risk of progression or demise in comparison with pomalidomide and dexamethasone alone. The result is significant because the study included a particularly relapsed, refractory and difficult-to-treat patient population, which was highly reflecting real-world practice, he added.
Isatuximab combination therapy has shown a statistically significant improvement in progression free survival, and the median progression free survival was longer in the isatuximab combination therapy arm than pom-dex alone.
What is Isatuximab?
Isatuximab is an experimental monoclonal antibody which targets a particular epitope on the CD38 receptor of a plasma cell. It is designed for the treatment of cancer. Developed by ImmunoGen and Sanofi with the development name SAR-650984, it was given orphan drug status for multiple myeloma by the FDA in December 2016.
Jerome Lipper, MD, clinical program leader, principal investigator, director of clinical research, Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute