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.
POMALYST® (pomalidomide) + dex + isatuximab:
An approved triplet in RRMM.1
For adult patients with RRMM who had received
REVLIMID® (lenalidomide)* and a PI.
Trial Design.1,2
POMALYST + dex + isa was studied in a Phase 3, multicenter, randomized, 2-arm, open-label trial of 307 patients with RRMM who had received at least 2 prior therapies including REVLIMID and a PI. Patients were eligible for inclusion if they had an ECOG status of 0-2, platelets ≥75,000 cells/mm3, absolute neutrophil count ≥1 x 109/L, CrCl ≥30mL/min (MDRD formula), and AST and/or ALT ≤3x ULN. Patients were randomized 1:1 to receive either POMALYST + dex + isa (n=154) or POMALYST + dex (n=153). Treatment was administered in both groups in 28-day cycles until disease progression or unacceptable toxicity. Isa 10 mg/kg was administered as an IV infusion weekly in the first cycle and every 2 weeks after. POMALYST 4 mg was taken orally once daily on Days 1-21 of each 28-day cycle. Low-dose dex (oral or IV) 40 mg (20 mg for patients ≥75 years old) was given on Days 1, 8, 15, and 22 for each 28-day cycle. The efficacy of POMALYST + dex + isa was based upon PFS.
†20 mg for patients ≥75 years old.
Information about POMALYST + dex + isatuximab (isa) does not appear in the POMALYST full Prescribing Information. Please see the isatuximab-irfc full PI for a discussion of Important Safety Information at www.sarclisa.com.
Indication for POMALYST + dex + isa.
POMALYST + dex + isa 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.
CONTRAINDICATIONS FOR ISATUXIMAB-IRFC
Isatuximab-irfc is contraindicated in patients with severe hypersensitivity to isatuximab-irfc or to any of its excipients.
WARNINGS AND PRECAUTIONS FOR ISATUXIMAB-IRFC
Infusion-Related Reactions: Interrupt isatuximab-irfc and manage medically. Permanently discontinue for Grade ≥3 reactions.
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 (SPM): Monitor patients for the development of SPM, as per IMWG guidelines.
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.
THE MAJORITY OF PATIENTS STUDIED WERE REFRACTORY TO REVLIMID1
Patients had received a median of 3 prior lines of therapy
- Prior therapies included: PI (all patients), REVLIMID (all patients), stem cell transplantation (56%)
- Medium patient age was 67 years (range: 36-86); 58% of patients were male; 76% of patients were white and 14% were Asian
- 10% of patients had a history of COPD or asthma; 34% had renal impairments (CrCl <60mL/min/1.73 m2
- ISS Stage was I in 37%, II in 36%, and III in 25% of patients
- 20% of patients had high-risk chromosomal abnormalities: 12% of patients has del(17p), 8% had t(4;14), and 2% had t(14;16)
isa, isatuximab-irfc; IV, intravenous; PFS, progression-free survival; PI, proteasome inhibitor; ORR, overall response rate; RRMM, relapsed/refractory multiple myeloma.
*Please see full Prescribing Information, including Boxed WARNINGS, for REVLIMID.
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 randomized, multicentre, open-label phase 3 study. Lancet. 2019;394(10214):2096-2107.