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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Multiple Myeloma |
| Drug: | Sarclisa (isatuximab-irfc) (CD38 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
New SARCLISA® (isatuximab for injection) Combination Now Approved by Health Canada for Adults with Relapsed and/or Refractory Multiple Myeloma
Published date:
10/13/2021
Excerpt:
Sanofi Canada is pleased to announce that Health Canada has approved SARCLISA® in combination with carfilzomib and dexamethasone (Kd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.
Secondary therapy:
carfilzomib
Source:
Published date:
03/31/2021
Excerpt:
SARCLISA is a CD38-directed cytolytic antibody indicated:...in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor...in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have
received 1 to 3 prior lines of therapy.
Secondary therapy:
carfilzomib; pomalidomide
Source:
Published date:
05/30/2020
Excerpt:
Sarclisa is indicated, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI) and have demonstrated disease progression on the last therapy.
Secondary therapy:
pomalidomide
Source:
Excerpt:
SARCLISA is a CD38-directed cytolytic antibody indicated, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
Secondary therapy:
pomalidomide
Source:
Published date:
09/14/2022
Excerpt:
THERAPY FOR PREVIOUSLY TREATED MULTIPLE MYELOMA...Isatuximab-irfc/carfilzomib/dexamethasone (category 1)
Secondary therapy:
carfilzomib
Source:
Title:
Isatuximab with pomalidomide and dexamethasone for treating relapsed and refractory multiple myeloma
Published date:
11/18/2020
Excerpt:
Isatuximab, plus pomalidomide and dexamethasone, is recommended for use
within the Cancer Drugs Fund as an option for treating relapsed and refractory
multiple myeloma in adults who have had lenalidomide and a proteasome
inhibitor, and whose disease has progressed on their last treatment...
Secondary therapy:
pomalidomide
Source:
Excerpt:
Multiple Myeloma: Therapy for previously treated multiple myeloma…Other Recommended Regimens… Isatuximab-irfc/carfilzomib/dexamethasone
Source:
Title:
Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma: updated results from IKEMA, a randomized Phase 3 study
Published date:
05/09/2023
Excerpt:
Consistent with the primary interim analysis, the addition of Isa to Kd prolonged PFS (HR 0.58, 95.4% CI: 0.42-0.79; median PFS 35.7 [95% CI: 25.8-44.0] vs 19.2 [95% CI: 15.8-25.0] months). PFS benefit was observed with Isa-Kd across subgroups, including patients with poor prognosis...These findings further support Isa-Kd as a standard-of-care treatment for relapsed multiple myeloma patients.
Secondary therapy:
carfilzomib
DOI:
10.1038/s41408-023-00797-8
Trial ID:
Source:
Title:
Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial
Published date:
06/04/2021
Excerpt:
The addition of isatuximab to carfilzomib–dexamethasone significantly improves progression-free survival and depth of response in patients with relapsed multiple myeloma.
Secondary therapy:
carfilzomib
DOI:
https://doi.org/10.1016/S0140-6736(21)00592-4
Trial ID:
Source:
Title:
CHMP recommends approval of Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone for the treatment of relapsed multiple myeloma
Published date:
02/26/2021
Excerpt:
CHMP recommends approval of Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone for the treatment of relapsed multiple myeloma...Recommendation based on data from Phase 3 IKEMA study in which Sarclisa combination therapy demonstrated a statistically significant improvement of progression free survival compared to standard of care carfilzomib and dexamethasone...
Secondary therapy:
carfilzomib
Source:
Title:
Depth of Response and Response Kinetics in the Icaria-MM Study of Isatuximab with Pomalidomide/Dexamethasone in Relapsed/Refractory Multiple Myeloma
Published date:
11/06/2019
Excerpt:
Median PFS was 11.53 months with Isa-Pd and 6.47 months with Pd (hazard ratio [HR] 0.596; 95% confidence interval [CI] 0.436-0.814). Tumor responses on Isa-Pd were more frequent and deeper than on Pd. Overall response rates (ORR) were 60.4% vs 35.3% (odds ratio [OR] 2.80; 95% CI 1.72-4.56; p<0.0001); at least very good partial response rates (≥VGPR) were 31.8% vs 8.5% (OR 5.03; 95% CI 2.51-10.59;
Secondary therapy:
pomalidomide
DOI:
https://doi.org/10.1182/blood-2019-129840
Trial ID:
Source:
Title:
Isatuximab Plus Carfilzomib and Dexamethasone Vs Carfilzomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma (IKEMA): Interim Analysis of a Phase 3, Randomized, Open-Label Study
Excerpt:
In this Phase 3 study (NCT03275285), pts with RRMM and 1-3 prior lines of therapy were randomized 3:2 and stratified by number of prior lines and R-ISS to receive Isa-Kd or Kd….PFS benefit was consistent across subgroups. ORR (≥partial response [PR]) was 86.6% Isa-Kd vs 82.9% Kd, one-sided p=0.1930....Addition of Isa to Kd provided a superior, statistically significant improvement in PFS with clinically meaningful improvement in depth of response.
Secondary therapy:
carfilzomib
Trial ID:
