What You Need to Know About the FDA's Approval of Sarclisa for Multiple Myeloma

The Food and Drug Administration (FDA) recently approved the targeted therapy Sarclisa (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex), in part, due to reducing the risk of disease progression and increasing the progression free survival rate for patients with multiple myeloma.

The approval of this combination is for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, however, the hope for Sarclisa is to be another frontline option for patients with multiple myeloma.

“In my view, (Sarclisa) has advantages for patients as a drug of choice for patients, because it's very easy to give,” Dr. Paul Richardson said in an interview with CURE®. Richardson, clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute, also explained that this drug is given through intravenous infusion and is faster than other multiple myeloma treatments. Sarclisa also inhibits the activity of the protein CD38 to help certain cells in the immune system attack cancer cells that are weakening it and sets itself apart from other multiple myeloma treatments such asDarzalex (daratumumab).

The approval for Sarclisa comes from data based on the ICARIA-MM study that looked at 307 patients with recurrent or treatment-resistant myeloma, who had taken at least two prior therapies, on Sarclisa and dexamethasone versus dexamethasone alone. Researchers found a statistically significant improvement in progression-free survival (the time from treatment to disease worsening or progression) in the Scarlisa and dexamethasone compared to the dexamethasone alone arm, 11.53 months and 6.47 months respectively. Moreover, Scarlisa in combination with dexamethasone had a greater overall response as well, 60.4% compared to 35.3% in the dexamethasone alone arm.

“We're able to show a substantial clinical benefit,” said Richardson, who was a principal investigator on the ICARIA-MM study. “(The) doubling of progression free survival, essentially from six months to 12 months with the use of the antibody. And I think what's important is that the antibody is different to daratumumab. It also binds different epitopes and works more on the apoptotic pathway of killing the myeloma than the daratumumab does, so it's qualitatively different.”

Common side effects for Sarclisa included drops in white blood cell or platelet levels, reactions at the infusion site, pneumonia, upper respiratory tract infections, diarrhea and anemia. Seven percent of patients in the trial discontinued due to grades 3-4 side effects and 3% of patients discontinued due to an infusion-related incident.

“It has a very low rate of infusion reactions and the amount of steroids needed with it is very low,” explained Richardson. “The side effect profile really revolved around a higher incidence of chest infections and suppression of blood counts, but all of those proved very manageable.”

Read CURE®’s original coverage of the approval.