ASCO 2025: Subcutaneous Sarclisa with On-Body Injector Shows Promise in Multiple Myeloma Treatment
At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, Sanofi presented promising data from two pivotal clinical trials evaluating the investigational subcutaneous (SC) delivery of Sarclisa (isatuximab-irfc) via an innovative on-body injector (OBI) device in patients with relapsed or refractory multiple myeloma (R/R MM). The results reinforce the potential of this delivery method to preserve the drug’s therapeutic efficacy while improving convenience and comfort for patients and healthcare providers alike.
A Shift in Drug Delivery: The Case for On-Body Injectors
Sarclisa is currently approved in intravenous (IV) form in combination with standard regimens for treating adults with R/R MM. However, prolonged infusion times and the need for dedicated clinical infrastructure can create logistical and emotional burdens for patients undergoing repeated therapies.
The subcutaneous route—especially via an OBI—presents a transformative opportunity to alleviate these burdens. OBIs are compact, wearable devices designed to administer medications over a set period without requiring IV lines or manual injections. These systems can enable more autonomous treatment experiences, decrease the time patients spend in infusion chairs, and potentially reduce strain on clinic staff.
Sanofi’s investigational subcutaneous formulation of Sarclisa is administered using Enable Injections’ enFuse® on-body delivery system. The enFuse device features a retractable 30-gauge hidden needle and is engineered to handle large-volume injections. With a simple click, the wearable system initiates drug delivery, allowing patients to move freely during administration while providers can monitor injection progress hands-free.
IRAKLIA: First Phase 3 Study of an OBI in Multiple Myeloma
The highlight of Sanofi’s ASCO presentation was the full data readout from the global Phase 3 IRAKLIA study, the first clinical trial to incorporate an OBI for treating multiple myeloma. This randomized, open-label, non-inferiority study compared subcutaneous Sarclisa via OBI against the conventional intravenous formulation, both combined with pomalidomide and dexamethasone (Pd), in adult patients with R/R MM who had undergone at least one prior line of therapy.
As of the data cut-off on November 6, 2024, with a median follow-up of 12 months, the IRAKLIA trial met its primary endpoint of demonstrating non-inferior efficacy and pharmacokinetics between the subcutaneous and IV routes. These results mark a pivotal step toward expanding administration options for patients and providers.
While specific efficacy metrics and survival outcomes were not detailed in the ASCO abstract, the demonstration of comparable pharmacokinetics supports the argument that the subcutaneous formulation maintains systemic drug levels consistent with those achieved via intravenous infusion. This is a key requirement for securing regulatory approval and clinical adoption.
Secondary Findings: Tolerability and Administration Experience
Beyond efficacy, tolerability and patient satisfaction were critical elements of the IRAKLIA trial and its companion Phase 2 study, IZALCO. According to investigators, the subcutaneous formulation of Sarclisa was well-tolerated and did not reveal any unexpected safety signals. The adverse event profile remained consistent with previous data on Sarclisa’s use in multiple myeloma.
Investigators also noted that the enFuse on-body injector offers practical advantages. The needle gauge and hidden insertion may enhance patient comfort, while the hands-free nature of the device could reduce the physical strain on nursing staff, particularly in busy infusion clinics.
In focus group studies and surveys referenced in the presentation, patients expressed high levels of satisfaction with the on-body administration experience. Many preferred it over traditional IV infusions or manual subcutaneous injections due to perceived improvements in comfort, mobility, and treatment autonomy.
IZALCO Phase 2 Study: Further Validating the SC Approach
Sanofi also presented data from the IZALCO Phase 2 study, which provided additional support for the feasibility and safety of subcutaneous Sarclisa delivered via the on-body system. The trial evaluated injection tolerability, device usability, and pharmacokinetics in patients with R/R MM.
Although smaller in scale than IRAKLIA, the IZALCO study allowed investigators to closely examine the performance of the enFuse device in a real-world setting. The hands-free nature of the device and the simplified administration process were particularly well-received by healthcare professionals. The study also underscored the practicality of using the OBI in outpatient settings, potentially opening doors to home-based administration models in the future.
Expert Perspective: A Step Toward Reducing Treatment Burden
Dr. Alyssa Johnsen, MD, PhD, Global Therapeutic Area Head of Immunology and Oncology Development at Sanofi, emphasized the significance of these findings:
Our subcutaneous clinical program is rooted in our mission to address patient needs and reduce treatment burden in multiple myeloma. We believe the novel on-body injector represents a significant innovation that could improve and streamline the treatment process for both patients and providers. We are pleased to share these data, the first to evaluate an on-body injector with a multiple myeloma treatment, and look forward to potentially bringing this formulation and administration option to the multiple myeloma community.”
Her remarks underline the potential for this advancement to transform the standard of care in a disease where patients frequently face years of chronic therapy, frequent clinic visits, and treatment-related fatigue.
Regulatory Path Ahead
Though the subcutaneous administration of Sarclisa with the enFuse OBI remains investigational and has not yet received approval from any regulatory authority, the positive results from IRAKLIA and IZALCO could set the stage for a formal submission in the near future.
If approved, Sarclisa would become the first multiple myeloma treatment available via an OBI, marking a milestone in drug delivery innovation for hematologic malignancies. Such an advancement would not only modernize the way therapies are administered but also exemplify how pharmaceutical innovation can evolve to meet the real-world needs of patients and caregivers.
Redefining Treatment Experience
The move toward subcutaneous, on-body injection systems reflects a broader shift in oncology and chronic disease management. As healthcare systems increasingly prioritize patient-centered care, minimizing the logistical and emotional burdens of treatment is becoming just as important as prolonging survival.
For patients with multiple myeloma—a population that often experiences relapse and requires long-term treatment—the ability to safely receive therapy via a discreet, wearable device may represent a dramatic improvement in quality of life. Similarly, healthcare providers may benefit from time-saving efficiencies and more streamlined clinic workflows.
In sum, the ASCO 2025 presentation of Sarclisa’s subcutaneous formulation administered via the enFuse on-body injector signals a bold step forward in modernizing cancer care. By preserving efficacy while improving the treatment experience, Sanofi’s innovation could reshape the delivery paradigm for multiple myeloma and potentially serve as a blueprint for similar advancements across other therapeutic areas.
