Isatuximab plus pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma in real‐world: The retrospective IMAGE study

• Published in: European journal of haematology 2024-09, Vol.113 (3), p.290-297
• Main Authors: Decaux, Olivier, Fontan, Jean, Perrot, Aurore, Karlin, Lionel, Touzeau, Cyrille, Schulmann, Samantha, Manier, Salomon, Belhadj, Karim, Trebouet, Adrien, Zunic, Patricia, Schiano De Colella, Jean‐Marc, Castel, Brice, Van De Wyngaert, Zoé, Pica, Gian Matteo, Tiab, Mourad, Kuhnowski, Frédérique, Bouketouche, Malek, Rigaudeau, Sophia, Benramdane, Riad, Tekle, Christina, Lafore, Radhia, Gaucher, Marianne, Corre, Jill, Leleu, Xavier
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - adverse effects; Antibodies, Monoclonal, Humanized - therapeutic use; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Cancer; Dexamethasone; Dexamethasone - administration & dosage; Dexamethasone - adverse effects; Dexamethasone - therapeutic use; Drug Resistance, Neoplasm; Female; Humans; isatuximab; Life Sciences; Male; Middle Aged; Multiple myeloma; Multiple Myeloma - diagnosis; Multiple Myeloma - drug therapy; Multiple Myeloma - mortality; Neutropenia; Patients; pomalidomide; real‐world; Recurrence; Response rates; Retrospective Studies; Thalidomide - administration & dosage; Thalidomide - analogs & derivatives; Thalidomide - therapeutic use; Treatment Outcome
• ISSN: 0902-4441; 1600-0609; 1600-0609
• DOI: 10.1111/ejh.14225

Background 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). Methods 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. Results 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%). Conclusion 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.