March 02, 2020
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FDA approves Sarclisa regimen for adults with advanced multiple myeloma

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Richard Pazdur
Richard Pazdur

The FDA approved isatuximab-irfc in combination with pomalidomide and dexamethasone for the treatment of adults with multiple myeloma who received at least two previous therapies, including lenalidomide and a proteasome inhibitor.

Isatuximab-irfc (Sarclisa, Sanofi) is an IV-administered monoclonal antibody that binds to the CD38 receptor on the surface of multiple myeloma cells.

“Targeting cells has led to the development of important oncology treatments,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a press release. “[Although] there is no cure for multiple myeloma, Sarclisa is now another CD38-directed treatment option added to the list of FDA-approved treatments of patients with multiple myeloma who have progressive disease after previous therapies.”

Pazdur cited the 40% reduction in the risk for disease progression or death with isatuximab-irfc among patients in the randomized, phase 3 ICARIA-MM trial, results of which served as the basis for FDA approval.

Isatuximab-irfc plus pomalidomide and dexamethasone conferred a significant increase in ORR (P < .0001) compared with pomalidomide and dexamethasone alone.

The trial evaluated isatuximab-irfc in combination with pomalidomide (Pomalyst, Celgene) and dexamethasone among patients with relapsed or refractory multiple myeloma. The results were presented at last year’s ASCO Annual Meeting and previously reported by Healio.

Isatuximab-irfc plus pomalidomide and dexamethasone conferred a significant increase in overall response rate (60.4% vs. 35.3%; P < .0001) compared with pomalidomide and dexamethasone alone. The trial investigators also reported longer median PFS in the isatuximab-irfc group (11.5 months vs. 6.5 months; HR = 0.59; 95% CI, 0.44-0.81), with a median treatment duration of 41 weeks in the isatuximab-irfc group and 24 weeks in the pomalidomide/dexamethasone group.

The most common adverse reactions among patients who received isatuximab-irfc included neutropenia (96%), upper respiratory tract infection (57%), infusion-related reactions (39%), pneumonia (31%) and diarrhea (26%). Patients in the isatuximab-irfc group experienced higher rates of grade 3 or higher adverse events (86.8% vs. 70.5%), serious adverse events (61.8% vs. 53.7%), grade 3 or higher infections (42.8% vs. 30.2%), grade 3 or higher neutropenia (84.9% vs. 70.1%), and grade 3 or higher febrile neutropenia (11.8% vs. 2%). A smaller proportion of patients who received the isatuximab-irfc regimen discontinued treatment due to adverse events (7.2% vs. 12.8%) or died of adverse events (7.9% vs. 9.4%).

Richardson_Paul_80x106
Paul G. Richardson

“Most patients with multiple myeloma unfortunately relapse and become refractory to currently available therapies. Sarclisa used in combination with pomalidomide and dexamethasone offers an important new treatment option for patients in the United States living with this incurable disease,” Paul G. Richardson, MD, principal investigator of ICARIA-MM, clinical program leader and director of clinical research at Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute, and a HemOnc Today Editorial Board Member, said in a Sanofi-issued press release.

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“The pivotal ICARIA-MM trial was the first phase 3 study of a CD38 antibody in combination with [pomalidomide and dexamethasone] to present results demonstrating significant clinical benefit in this setting,” Richardson said. “The study enrolled a broad population of patients with relapsed and refractory multiple myeloma that is particularly difficult to treat and with poor prognosis, which is reflective of real-world practice.”

Isatuximab-irfc previously received orphan drug designation from the FDA and is being evaluated in other phase 3 trials for multiple myeloma, including as first-line therapy for patients with newly diagnosed multiple myeloma and as first line-therapy for those ineligible for transplant.

“Today’s FDA approval of Sarclisa provides a new treatment option for patients with difficult-to-treat multiple myeloma,” Paul Hudson, CEO of Sanofi, said in the company-issued press release. “We continue to evaluate Sarclisa in a comprehensive clinical program in multiple myeloma, as well as in other blood cancers and solid tumors.”