Subcutaneous isatuximab by on-body-injector plus bortezomib, lenalidomide, and dexamethasone in newly diagnosed transplant-ineligible multiple myeloma: ISASOCUT study
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 primary endpoint was met, with a ≥VGPR rate of 88% (95% CI, 78–94, p < 0.001). 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.
Authors
- Anaïs Schavgoulidze (ORCID: https://orcid.org/0000-0002-5526-4279)
- Douaa Dhahri (ORCID: https://orcid.org/0000-0003-0141-1728)
- Lionel Karlin (ORCID: https://orcid.org/0000-0002-1185-4488)
- Jill Corre (ORCID: https://orcid.org/0000-0003-1580-6106)
- Titouan Cazaubiel (ORCID: https://orcid.org/0009-0007-5834-5318)
- Murielle Roussel (ORCID: https://orcid.org/0000-0002-4045-9428)
- Salomon Manier (ORCID: https://orcid.org/0000-0001-7653-711X)
- Nicolas Branche
- Xavier P Leleu (ORCID: https://orcid.org/0000-0002-9822-4170)
- Rick Zhang
- Julie Gay (ORCID: https://orcid.org/0009-0006-8923-6010)
- Cyrille Touzeau (ORCID: https://orcid.org/0000-0003-0275-2575)
- Muriel Newinger-Porte
- Arthur Bobin (ORCID: https://orcid.org/0000-0002-8416-391X)
- Thomas Chalopin (ORCID: https://orcid.org/0000-0002-9833-3115)
- Aurore Perrot (ORCID: https://orcid.org/0000-0003-0131-8689)
- Lydia Montes (ORCID: https://orcid.org/0000-0003-3854-4209)
- Christophe Roul
- Cyrille Hulin (ORCID: https://orcid.org/0000-0002-3749-5161)
- Philippe Moreau (ORCID: https://orcid.org/0000-0003-1780-8746)
- Olivier Fitoussi (ORCID: https://orcid.org/0009-0009-6401-6603)
- Mamoun Dib
- Mourad Tiab
- Jean‐Sébastien Blade
- Marlène Ochmann
- Alberto Santagostino
- Lisa Durocher (ORCID: https://orcid.org/0009-0001-0547-7874)
- Reza Tabrizi
- adrienne de thomas de labarthe
- Thierry Facon (ORCID: https://orcid.org/0000-0001-7705-8460)
- Margaret Macro
- Frédérique Orisini Piocelle
- Mohamad Mohty
- Stéphanie Ragot
- Mony Morisse Chenda
Institutions
- Sanofi (France) (FR)
- Centre Hospitalier Universitaire de Bordeaux (FR)
- Centre Hospitalier Universitaire de Lille (FR)
- Centre Hospitalier Universitaire de Nantes (FR)
- Service de Santé des Armées (FR)
- Université de Poitiers (FR)
- Hewlett-Packard (France) (FR)
- Lille’s Cardiology Hospital (FR)
- Centre Hospitalier Universitaire de Tours (FR)
- Centre Hospitalier Universitaire Amiens-Picardie (FR)
- Assistance Publique – Hôpitaux de Paris (FR)
- Institut universitaire du cancer de Toulouse Oncopole (FR)
- Centre Hospitalier Universitaire de Nîmes (FR)
- Centre Hospitalier Universitaire de Poitiers (FR)
- Centre Hospitalier Universitaire d'Angers (FR)
- Les Hôpitaux de Chartres (FR)
- Hôpital Lyon Sud (FR)
- Centre Hospitalier Universitaire de Caen Normandie (FR)
- Hôpital Nord (FR)
- Polyclinique Bordeaux Nord Aquitaine (FR)
- Centre Hospitalier Universitaire de Limoges (FR)
- Centre Hospitalier de Troyes (FR)
- Centre Hospitalier de la Côte Basque (FR)
- Centre d'Investigation Clinique de Nantes (FR)
- Centre Hospitalier Annecy Genevois (FR)
- Centre Hospitalier de La Rochelle (FR)
- Centre hospitalier universitaire d'Orléans (FR)
- Centre Hospitalier Départemental Vendée (FR)
- Groupe Hospitalier de la Région de Mulhouse et Sud Alsace (FR)
- Université de Caen Normandie (FR)
Publication Details
- Journal
- Blood Cancer Journal
- Published
- 2026-10-09
- DOI
- https://doi.org/10.1038/s41408-026-01634-4
- Primary Topic
- Multiple Myeloma Research and Treatments
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Sanofi