On September 20, 2024, the Food and Drug Administration sanctioned isatuximab-irfc (Sarclisa, Sanofi-Aventis U.S. LLC) in conjunction with bortezomib, lenalidomide, and dexamethasone for people with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT).
Efficacy and Safety
The efficacy was assessed in IMROZ (NCT03319667), an open-label, randomized, active-controlled phase 3 trial involving patients with newly diagnosed multiple myeloma who were ineligible for ASCT. Enrollment was restricted to patients aged 80 years and below. A total of 446 patients were randomized in a 3:2 ratio to receive either isatuximab-irfc combined with bortezomib, lenalidomide, and dexamethasone (Isa-VRd) or bortezomib, lenalidomide, and dexamethasone (VRd).
The primary effectiveness endpoint was progression-free survival (PFS), evaluated by an independent review committee according to International Myeloma Working Group guidelines. IMROZ exhibited an enhancement in progression-free survival (PFS) in the Isa-VRd cohort, indicating a 40% reduction in the risk of disease progression or mortality (hazard ratio 0.60 [95% CI: 0.44, 0.81]; p-value 0.0009); the median PFS was not attained (NR) (95% CI: NR, NR) in the Isa-VRd cohort, while it was 54.3 months (95% CI: 45.2, NR) in the VRd cohort.
The predominant adverse events (≥20%) included upper respiratory tract infection, diarrhea, lethargy, peripheral sensory neuropathy, pneumonia, musculoskeletal discomfort, cataract, constipation, peripheral edema, rash, infusion-related reaction, insomnia, and COVID-19 infection.
The advised dosage of isatuximab-irfc is 10 mg/kg of real body weight, delivered via intravenous infusion. Refer to the prescribing material for dosage recommendations of the other medications.
Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. His career is marked by significant contributions to stem cell biology, developmental biology, and innovative research techniques.
Research Highlights
Dr. Mittal's research has focused on several key areas:
1) Cardiovascular Development and Regeneration: He studied coronary vessel development and regeneration using zebrafish models1.
2) Cancer Biology: At Dartmouth College, he developed zebrafish models for studying tumor heterogeneity and clonal evolution in pancreatic cancer.
3) Developmental Biology: His doctoral work at Keio University involved identifying and characterizing medaka fish mutants with cardiovascular defects.
4) Stem Cell Research: He investigated the effects of folic acid on mouse embryonic stem cells and worked on cryopreservation techniques for hematopoietic stem cells.
Publications and Presentations
Dr. Mittal has authored several peer-reviewed publications in reputable journals such as Scientific Reports, Cardiovascular Research, and Disease Models & Mechanisms1. He has also presented his research at numerous international conferences, including the Stanford-Weill Cornell Cardiovascular Research Symposium and the Weinstein Cardiovascular Development Conference.
In summary, Dr. Nishant Mittal is a dedicated and accomplished researcher with a strong track record in cardiovascular and cancer biology, demonstrating expertise in various model systems and a commitment to advancing scientific knowledge through innovative research approaches.
