Dr. Richardson on the FDA Approval of Isatuximab in Relapsed/Refractory Myeloma

Paul G. Richardson, MD, clinical program leader and director of clinical research, Jerome Lipper Multiple Myeloma Center, and institute physician, Dana-Farber Cancer Institute, and RJ Corman Professor of Medicine at Harvard Medical School, discusses the implications of the FDA approval of isatuximab-irfc (Sarclisa) for use in combination with pomalidomide (Pomalyst) and dexamethasone in relapsed/refractory multiple myeloma.

On March 2, 2020, the FDA approved the triplet for use in adult patients with myeloma who have received ≥2 prior therapies, including lenalidomide (Revlimid) and a proteasome inhibitor. The approval was based on data from the phase III ICARIA-MM trial, in which the addition of isatuximab to pomalidomide and low-dose dexamethasone led to a greater than 40% reduction in the risk of disease progression or death compared with pomalidomide and dexamethasone alone in patients with relapsed/refractory multiple myeloma.

The triplet is effective in high-risk patients and it works quickly, which is important, says Richardson. The regimen has activity in patients with renal disease, and it can be given to patients who have some degree of pulmonary risk, which makes this an attractive option, adds Richardson. Furthermore, the regimen is administered on a weekly schedule for the first month and then every 2 weeks thereafter, which is convenient for patients. There is also a relatively short infusion time with the triplet, adds Richardson.

The advantage of isatuximab is that it has an antiapoptotic mechanism via an ectoenzymatic engagement of the epitope where the CD38 is expressed, which may make it more appealing for a patient who has received multiple lines of treatment, including daratumumab (Darzalex), concludes Richardson.