The FDA has approved Sarclisa, together with Kyprolis and dexamethasone (Kd), in order to treat adult patients with the relapsed or refractory multiple myeloma (RRMM) who previously have taken 1 to 3 prior lines of therapy.
According to Thomas G. Martin, M.D., Associate Director, Myeloma Program, The University of California, San Francisco, Professor of Medicine, Adult Leukemia and Bone Marrow Transplantation Program and co-leader of the Hematopoietic Malignancies Program, “In the phase-III IKEMA-study, the addition of Sarclisa to Kyprolis(or carfilzomib) and dexamethasone helps in order to reduce the risk of disease progression or death by 45%.”
“Approval by FDA of the sarclisa (Isatuximab) is a remarkable landmark for such patients whose cancer has relapsed and strengthened the potential for this medicine in order to become an excellence of care in RRMM,” Thomas G. Martin added.
This marks the 2’nd FDA approval for Sarclisa (Isatuximab), which is also approved together with the pomalidomide and dexamethasone (pom-dex) in order to treat adults with RRMM who have taken at least 2-prior therapies including PI and Revlimid.
Peter C. Adamson, M.D., Global Development Head, Oncology and Pediatric Innovation at Sanofi stated that, “Treatment of patients with RRMM remains challenging and the prognosis for patients experiencing multiple relapses regrettably is poor.”
“With this breakthrough, the agent Sarclisa (Isatuximab) is now entered in 2-standard care regimens for treating multiple myeloma patients as primary as first relapse. This breakthrough further favours our ambition for Sarclisa (Isatuximab) in order to become the anti-CD38 of choice for patients with RRMM,” Peter C. Adamson added.
This FDA approval takes place on behalf of findings from the phase-III IKEMA-study, in which a total of 302 patients enrolled with relapsed MM across 69 centers spanning 16 nations.
In this carried out study, Sarclisa added to the Kyprolis and dexamethasone reduced the risk of disease progression or death by the 45% (hazard ratio 0.548, 95% CI 0.366 to 0.822, p=0.0032) vs standard of care Kyprolis and dexamethasone alone in multiple myeloma patients.
The median PFS for the Sarclisa (Isatuximab), Kyprolis and dexamethasone was not reached at the time of the pre-planned interim analysis. This study basically enrolled a difficult to treat patient group, including those who are elderly, have greater cytogenetic risk or renal impairment.
All-inclusive, the demographic and disease characteristics at the baseline were balanced between a couple of treatment populations.
Secondary endpoints of the IKEMA-trial evaluated the ORR for Sarclisa, Kyprolis and dexamethasone compared to Kyprolis and dexamethasone, CR) and VGPR.
The absence of statistically noteworthy distinctions in ORR have been noted, that persisted identical for one and all arm at the 86.6% for the Sarclisa, Kyprolis and dexamethasone vs 82.9% for Kyprolis and dexamethasone (p=0.3859).
The rate of CR was 39.7% in the Sarclisa, Kyprolis and dexamethasone arm and 27.6% in the Kyprolis and dexamethasone arm. The rate of VGPR was noted as 33% for patients taking Sarclisa, Kyprolis and dexamethasone and 28.5% for patients receiving Kyprolis and dexamethasone. At the time of the interim analysis, OS findings were still immature.
The most frequent side effects (reporting in 20% or more of patients) for Sarclisa (Isatuximab) vs the control arm were upper respiratory tract infection (67% versus 57%), infusion-related reactions (46% versus 3.3%), fatigue (42% versus 32%), hypertension (37% versus 32%), pneumonia (36% versus 30%), diarrhea (36% versus 29%), dyspnea (29% versus 24%), acute/chronic bronchitis (24% versus 13%), and cough (23% versus 15%).
Certain serious side effects, noted in over 5% of patients, taken regimen of Sarclisa, Kyprolis and dexamethasone were pneumonia (25%) and URTI (9%).