FINAL ANALYSIS:
44 months median
follow-up
IKEMA: SARCLISA + CARFILZOMIB
AND DEXAMETHASONE (Kd)
IKEMA Trial Results: SARCLISA + Kd vs
Kd Alone
Unprecedented results:
~42 months mPFS with SARCLISA + Kd
Longest ever reported in a phase 3 trial that included lenalidomide-refractory patients1-6*
*Based on a review of published phase 3 trials that included lenalidomide-refractory patients with RRMM. Interpret with caution, as various factors, including patient population, differ between trials.1,7
PFS results were assessed by an IRC, based on central laboratory data for M-protein, and central radiologic imaging review using IMWG criteria. A preplanned interim analysis was conducted when 65% of 159 PFS events were observed. P value is not reported as this is a non-inferential analysis of the primary endpoint that was met at the time of the interim analysis.1,7
Superior PFS vs Kd at
interim analysis
(median follow-up of 20.7 months)1
SARCLISA + Kd: mPFS NR
Kd: mPFS 20.27 months1
HR=0.548
(95% CI: 0.37, 0.82; P=0.0032)1
Final analysis: A prespecified final analysis was conducted when 159 PFS events were observed, with a median follow-up of 44 months.2
IMWG=International Myeloma Working Group; IRC=independent response committee; mPFS=median progression-free survival; M-protein=monoclonal protein; NR=not reached; RRMM=relapsed or refractory multiple myeloma.
The median duration of treatment was 94 weeks with SARCLISA + Kd vs 62 weeks with Kd alone. The median time to next treatment was 44.91 months (95% CI: 31.61, NR) in the SARCLISA + Kd arm vs 25.0 months (95% CI: 17.94, 31.31) with Kd alone7,8
National Comprehensive Cancer Network® (NCCN®) recommends isatuximab-irfc (sarclisa) in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma as a Category 1 Preferred option in combination with carfilzomib and dexamethasone or with pomalidomide and dexamethasone9:
- ✓ For early relapses (1-3 prior therapies)†
- ✓ Option for patients refractory to either lenalidomide or bortezomib
NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Recommendation for isatuximab-irfc (SARCLISA) in combination with carfilzomib and dexamethasone based on results of interim analysis.
†After 2 prior therapies including lenalidomide and a proteasome inhibitor for isatuximab-irfc in combination with pomalidomide and dexamethasone.
NCCN=National Comprehensive Cancer Network® (NCCN®).
Watch an expert review the results for SARCLISA + Kd vs Kd alone
"The median PFS of the IKEMA trial reinforces my confidence in prescribing SARCLISA + Kd in my patients with multiple myeloma at first relapse."2
– Dr Joseph Mikhael, MD
Explore a patient case with high-risk factors who may be
appropriate for SARCLISA + Kd at first relapse1
Patients in the IKEMA trial achieved deep responses2‡
High rates of ≥VGPR were seen in IKEMA
As ORR did not reach statistical significance, ≥VGPR and CR were not
tested for significance7
Interim analysis (20.7 months median follow-up)1,7
- ORR:
- - 86.6% (95% CI: 0.81, 0.91) with SARCLISA + Kd
- - 82.9% (95% CI: 0.75, 0.89) with Kd alone
- - P=0.3859; 95% CI estimated using the Clopper-Pearson method
- ≥VGPR: 72.6% with SARCLISA + Kd vs 56.1% with Kd alone
- CR: 39.7% with SARCLISA + Kd vs 27.6% with Kd alone
- MRD-: 30% with SARCLISA + Kd (95% CI: 0.23, 0.37) vs 13% with Kd alone (95% CI: 0.08, 0.20)
The median time to first response among responders was 1.08 months in the SARCLISA + Kd arm and 1.12 months in the Kd arm.7
‡A
response of
≥VGPR.7
asCR, CR, VGPR, and PR were evaluated by the IRC using the IMWG response criteria. Results are based on a prespecified final analysis with a median follow-up time of 44 months.1,8
CR=complete response; PR=partial response; sCR=stringent complete response; VGPR=very good partial response.
6 out of 10 patients in CR achieved MRD- with SARCLISA + Kd8
Rate of MRD- by adaptive NGS at 10-5§
Interim analysis (20.7 months median follow-up): MRD- rate in the ITT population was 30% with SARCLISA + Kd (95% CI: 0.23, 0.37) vs 13% with Kd alone (95% CI: 0.08, 0.20)1,7
In IKEMA, achieving MRD- translated into prolonged PFS
PFS by MRD status and treatment arm at the final analysis7
PFS results were assessed by an IRC, based on central laboratory data for M-protein, and central radiologic imaging review using the IMWG criteria.1
The addition of SARCLISA to Kd also improved PFS in patients who remained MRD+ (HR=0.71, 95% CI: 0.50, 1.00)7
Study limitations
According to the FDA, using MRD to assess clinical benefit of a multiple myeloma treatment should only be assessed in patients who achieve a CR or sCR. In the IKEMA trial, MRD was assessed in patients who achieved ≥VGPR. Additionally, there was an amount of missing data that did not meet the FDA’s threshold for label inclusion. This analysis requires cautious interpretation and clinical significance of these data is unknown.
§Based on a sensitivity level of 10-5 by NGS in patients who achieved ≥VGPR.7
ITT=intent to treat; MRD+=minimal (or measurable) residual disease positive/positivity; NGS=next-generation sequencing.
See the importance of MRD-
and how it was assessed in the IKEMA trial
IKEMA Trial Summary Brochure
An informative brochure that includes the IKEMA trial results for SARCLISA + Kd vs Kd alone
