POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
IN A PIVOTAL TRIAL IN WHICH 93% OF PATIENTS WERE REFRACTORY TO lenalidomide
Longer median PFS with
POMALYST® (pomalidomide) +
dex + isatuximab-irfc (IsaPd)
vs POMALYST + dex (Pd).1,2
- Stratified by age (<75 years vs ≥75 years) and number of previous lines of therapy (2 or 3 vs >3) according to interactive response technology. PFS was assessed by an Independent Response Committee (IRC) based on central laboratory data for M-protein and central radiologic imaging review using the IMWG criteria.
More patients responded to IsaPd vs Pd.1,2
- sCR, CR, VGPR, and PR were evaluated by the IRC using the IMWG response criteria.
- Stratified by age (<75 years vs ≥75 years) and number of previous lines of therapy (2 or 3 vs >3) according to interactive response technology.
- Estimated using the Clopper-Pearson method.
- The median time to first response in responders was 35 days in the IsaPd group vs 58 days in the Pd group
- The median duration of response was 13.3 months (95% CI 10.6, NR) in the IsaPd group vs 11.1 months (95% CI 8.5, NR) in the Pd group
- At interim analysis (median follow-up of 11.6 months), median OS was not reached for either treatment group
POMALYST + dexamethasone + isatuximab-irfc Indication (IsaPd)
POMALYST + dexamethasone + isatuximab-irfc is indicated for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
Important Safety Information
WARNINGS AND PRECAUTIONS FOR ISATUXIMAB-IRFC
- Infusion-Related Reactions: In case of Grade ≥2, interrupt isatuximab-irfc and manage medically. Permanently discontinue for Grade 4 infusion-related reactions or anaphylactic reaction.
- Neutropenia: Monitor complete blood cell count periodically during treatment. Monitor patients with neutropenia for signs of infection. Isatuximab-irfc dose delays and the use of colony-stimulating factor may be required to allow improvement of neutrophil count.
- Second Primary Malignancies: Monitor patients for the development of secondary primary malignancies.
- Laboratory Test Interference:
- Interference With Serological Testing (Indirect Antiglobulin Test): Isatuximab-irfc may result in a false positive indirect antiglobulin test (indirect Coombs test). Type and screen patients prior to starting treatment. Inform blood banks that a patient has received isatuximab-irfc.
- Interference With Serum Protein Electrophoresis and Immunofixation Tests: Isatuximab-irfc may interfere with the assays used to monitor M-protein, which may impact the determination of complete response.
- Embryo-Fetal Toxicity: Can cause fetal harm.
Information about IsaPd does not appear in the POMALYST Prescribing Information (PI). Please see the isatuximab-irfc full PI for a complete discussion of Important Safety Information at www.sarclisahcp.com.
CI, confidence interval; CR, complete response; dex, dexamethasone; HR, hazard ratio; IMWG, International Myeloma Working Group; isa, isatuximab-irfc; IsaPd, POMALYST + dexamethasone + isatuximab-irfc; mPFS, median progression-free survival; NR, not reached; ORR, overall response rate; OS, overall survival; Pd, POMALYST + dexamethasone; PFS, progression-free survival; PR, partial response; sCR, stringent complete response; VGPR, very good partial response.
References: 1. Isatuximab-irfc [package insert]. Bridgewater, NJ: sanofi-aventis U.S. LLC. 2. Attal M, Richardson PG, Rajkumar SV, et al. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label phase 3 study. Lancet. 2019;394(10214):2096-2107.