FDA Approves Addition of Sarclisa to Standard of Care for Relapsed/Refractory Myeloma

The Food and Drug Administration (FDA) approved Sarclisa (isatuximab) in combination with Kyprolis (carfilzomib) and dexamethasone, also known as Kd, to treat adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy, according to Sanofi, the agent’s manufacturer.

The treatment of this patient population has remained a challenge due to the disease’s poor prognosis, according to Dr. Peter C. Adamson, Global Development Head of Oncology and Pediatric Innovation at Sanofi. “With this approval, Sarclisa is now included in two standard-of-care regimens for the treatment of patients with multiple myeloma as early as first relapse. Today’s milestone further supports our ambition for Sarclisa to become the anti-CD38 of choice for patients with relapsed or refractory multiple myeloma,” he said in a press release.

The agency based its approval on data from the randomized, multicenter, open-label phase 3 IKEMA study, designed to evaluate the addition of Sarclisa to Kyprolis and dexamethasone in 302 patients with relapsed multiple myeloma.

The combination regimen reduced the risk for disease progression or death by 45% compared with Kyprolis and dexamethasone alone (the current standard of care for this patient population). The median progression-free survival (the time from treatment to disease worsening) was not reached with the addition of Sarclisa, according to the pre-planned interim analysis.

Moreover, there was no statistically significant difference in overall response rates between the combination and standard of care arms (86.6% versus 82.9%, respectively). The rate of complete responses was 39.7% and 27.6%, respectively, while the very good partial response rates were 33% and 28.5%.

The most common side effects in the combination and standard of care were upper respiratory tract infection (67% versus 57%), infusion-related reactions (46% versus 3.3%), fatigue (42% versus 32%), hypertension (37% versus 32%), diarrhea (36% versus 29%), pneumonia (36% versus 30%), dyspnea (29% versus 24%), bronchitis (24% versus 13%) and cough (23% versus 15%). Serious side effects in the Sarclisa combination therapy arm were pneumonia (25%) and upper respiratory tract infections (9%).

“In the Phase 3 IKEMA study, the addition of Sarclisa to (Kyprolis) and dexamethasone reduced risk of disease progression or death by 45%,” Dr. Thomas G. Martin, associate director of the Myeloma Program at The University of California, San Francisco, and professor of Medicine, Adult Leukemia and Bone Marrow Transplantation Program and co-leader of the Hematopoietic Malignancies Program at the Helen Diller Family Comprehensive Cancer Center, said in the release.

“This approval is an important advancement for patients whose disease has relapsed and reinforces the potential for Sarclisa to become a standard of care in relapsed or refractory multiple myeloma,” he added.

Of note, this is the second approval for Sarclisa, which is also approved in combination with pomalidomide and dexamethasone to treat adult patients with relapsed or refractory multiple myeloma who have received at least two prior therapies including Revllimiid (lenalidomide) and a proteasome inhibitor.

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