This week the FDA approved the use of the anti-CD38 monoclonal antibody isatuximab (Sarclisa) in combination with carfilzomib (Kyprolis) and dexamethasone for relapsed or refractory myeloma patients who received 1-3 prior therapies.
The approval was based on the Phase III IKEMA trial which showed that IsaKd triple combination reduced the risk of myeloma progression or death by 45% compared to Kd alone. The study has not yet met the median progression-free survival at the time of study reporting.
The study also showed the following results:
IsaKd | Kd | |
Overall Response Rate | 86.6% | 82.9% |
Complete Response | 39.7% | 27.6% |
Partial Response | 33% | 28.5% |
Most common side effects were:
Side Effect | IsaKd | Kd |
Respiratory tract infection | 67% | 57% |
Infusion related reactions | 46% | 3.3% |
Fatigue | 42% | 32% |
Hypertension | 37% | 32% |
Diarrhea | 36% | 29% |
Pneumonia | 36% | 30% |
Dyspnea | 29% | 24% |
Bronchitis | 24% | 13% |
Cough | 23% | 15% |
The most serious side effects in the isatuximab combination therapy arm were pneumonia (25%) and upper respiratory tract infections (9%).
Thomas Martin, MD and associate director and co-leader of the Hematopoietic Malignancies Program of the myeloma program at the University of California San Francisco (UCSF) said:
“In the Phase 3 IKEMA study, the addition of Sarclisa to carfilzomib and dexamethasone reduced risk of disease progression or death by 45%. 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.”
Isatixumab was previously approved for use with pomalidomide and dexamethasone who had received at least two prior therapies (including lenalidomide and a proteasome inhibitor.)
about the author
Jennifer Ahlstrom
Myeloma survivor, patient advocate, wife, mom of 6. Believer that patients can help accelerate a cure by weighing in and participating in clinical research. Founder of HealthTree Foundation (formerly Myeloma Crowd).
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