Subcutaneous isatuximab by on-body-injector plus bortezomib, lenalidomide, and dexamethasone in newly diagnosed transplant-ineligible multiple myeloma: ISASOCUT study
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: Isatuximab–bortezomib–lenalidomide–dexamethasone (Isa-VRd) has emerged as a standard of care for newly diagnosed multiple myeloma transplant-ineligible patients. A subcutaneous (SC) formulation of isatuximab delivered via an on-body injector (OBI) has been developed to facilitate treatment administration. ISASOCUT is a prospective, multicenter, phase 2 study evaluating the efficacy and tolerability of Isa SC-VRd administered via OBI. SC isatuximab (1400 mg) was given weekly during cycle 1, then on days 1 and 15 through cycle 12 in combination with VRd, followed by monthly isatuximab–lenalidomide until progression. The primary endpoint was the rate of ≥very good partial response (VGPR) at 8 months. Seventy-four patients were treated, with a median age of 73 years. At 8 months, the ≥VGPR rate was 88% (95% CI, 78–94). Minimal residual disease negativity was achieved in 36% at 10⁻⁵ and 28% at 10⁻⁶. At a median follow-up of 21.2 months, 14-month progression-free and event-free survival rates were 93.1% and 91.7%, respectively. The median relative dose intensity of isatuximab was 91.8%, with 99.3% of injections successfully completed. Infusion-related reactions occurred in 5% of patients, mostly low grade. ISASOCUT met its primary endpoint and supports SC isatuximab via OBI as a feasible alternative to intravenous administration.
Source: Blood Cancer Journal
Authors: Arthur Bobin, Lisa Durocher, Cyrille Touzeau, Nicolas Branche, Aurore Perrot, Mamoun Dib, Jean-Sébastien Blade, Thomas Chalopin, Lydia Montes, Julie Gay, Mourad Tiab, Margaret Macro, Titouan Cazaubiel, Frédérique Orisini Piocelle, Alberto Santagostino, Adrienne De Thomas De Labarthe, Marlène Ochmann, Christophe Roul, Reza Tabrizi, Muriel Newinger-Porte, Olivier Fitoussi, Mony Morisse Chenda, Rick Zhang, Douaa Dhahri, Murielle Roussel, Lionel Karlin, Mohamad Mohty, Philippe Moreau, Anaïs Schavgoulidze, Jill Corre, Thierry Facon, Cyrille Hulin, Salomon Manier, Stéphanie Ragot, Xavier Leleu
Institutions: Centre Hospitalier Universitaire de Poitiers, Centre Hospitalier Universitaire de Nantes, Centre Hospitalier Universitaire de Nîmes, Institut universitaire du cancer de Toulouse Oncopole, Centre Hospitalier Universitaire d'Angers, Service de Santé des Armées, Centre Hospitalier Universitaire de Tours, Centre Hospitalier Universitaire Amiens-Picardie, Centre Hospitalier de la Côte Basque, Centre Hospitalier Départemental Vendée, Centre Hospitalier Universitaire de Caen Normandie, Centre Hospitalier Universitaire de Bordeaux, Centre Hospitalier Annecy Genevois, Centre Hospitalier de Troyes, Les Hôpitaux de Chartres, Centre hospitalier universitaire d'Orléans, Centre Hospitalier de La Rochelle, Laboratoire d'hématologie, Groupe Hospitalier de la Région de Mulhouse et Sud Alsace, Polyclinique Bordeaux Nord Aquitaine, Sanofi (France), Centre Hospitalier Universitaire de Limoges, Hôpital Lyon Sud, Assistance Publique – Hôpitaux de Paris, Centre Hospitalier Universitaire de Lille
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $5,290
Funder: Sanofi
OpenAlex ID: W7220979471