{Reference Type}: Journal Article
{Title}: Isatuximab plus pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma in real-world: The retrospective IMAGE study.
{Author}: Decaux O;Fontan J;Perrot A;Karlin L;Touzeau C;Schulmann S;Manier S;Belhadj K;Trebouet A;Zunic P;Schiano De Colella JM;Castel B;Van De Wyngaert Z;Pica GM;Tiab M;Kuhnowski F;Bouketouche M;Rigaudeau S;Benramdane R;Tekle C;Lafore R;Gaucher M;Corre J;Leleu X;
{Journal}: Eur J Haematol
{Volume}: 113
{Issue}: 3
{Year}: 2024 Sep 7
{Factor}: 3.674
{DOI}: 10.1111/ejh.14225
{Abstract}: <B>BACKGROUND: </B>IMAGE is a retrospective cohort study of patients enrolled in early access programs (EAPs) in France with relapsed/refractory multiple myeloma (RRMM) receiving isatuximab with pomalidomide and dexamethasone (Isa-Pd).<BR><B>METHODS: </B>Patients aged ≥18 years with RRMM who received ≥1 dose of Isa under the EAPs between July 29, 2019 and August 30, 2020 were included. Effectiveness endpoints included progression-free survival (PFS) and response rates. Verbatim terms for adverse events (AEs) were coded using the Medical Dictionary for Regulatory Activities and not graded for severity.<BR><B>RESULTS: </B>A total of 294 and 299 patients were included in the effectiveness and safety populations, respectively. IMAGE included patients who received one prior line of treatment (10.2%) and were daratumumab-refractory (19.1%). At median follow-up of 14.2 months, median PFS in the effectiveness population was 12.4 months (95% CI 9.0-15.0). Overall response and very good partial response rates were 46.3% and 27.9%, respectively. Subgroup analyses reflected similar results. In the safety population, 26.4% of patients reported at least one AE; the most common any-grade AE was neutropenia (9.4%).<BR><B>CONCLUSIONS: </B>IMAGE demonstrated Isa-Pd had meaningful effectiveness in median PFS and depth of response and no new safety signals in a real-world context, consistent with clinical trial results.