Sarclisa Escena (isatuximab subcutaneous) / Sanofi - LARVOL DELTA

…Patient-reported outcomes (PRO) and subgroup analysis from the phase 3 IRAKLIA trial (NCT05405166) presented in a poster session at the 23rd Annual International Myeloma Society (IMS) Meeting & Exposition (Cancer Network) - "At cycle 5, day 15, patients treated with subcutaneous isatuximab via OBI reported higher satisfaction (96.8% vs 70.8%) and greater time savings (83.1% vs 32.7%) than those treated with intravenous isatuximab, along with numerically lower rates of discomfort (13.8% vs 16.3%) and pain (6.9% vs 10.4%). In subgroup analyses based on the Patient Experience and Satisfaction Questionnaire Follow-Up, a higher proportion of patients in the OBI arm disagreed or strongly disagreed that the injection method was uncomfortable (78.7% vs 64.3% among satisfied patients) or painful (89.1% vs 72.0% among satisfied patients) compared with the intravenous arm. A higher proportion of patients in the OBI arm also disagreed or strongly disagreed that the medication resulted in adverse effects (73.2% vs 55.9% among satisfied patients)."

P3 data • Patient reported outcomes • Multiple Myeloma

Patients Prefer At-Home Isatuximab Injector Over IV, IRAKLIA Data Show (Pharmacy Times) - "This IMS 2026 presentation is a dedicated patient-experience and satisfaction analysis layered on top of that already-approved efficacy and safety package. Among patients who reported being satisfied with their injection method at cycle 5, more patients on the subcutaneous OBI arm than the IV arm disagreed that their injection method was uncomfortable (78.7% vs 64.3%) or painful (89.1% vs 72.0%), and more reported fewer perceived medication adverse effects (AEs; 73.2% vs 55.9%)...A separate at-home administration substudy within IRAKLIA further reinforced the practicality case: among patients eligible for at-home dosing by a health care provider starting at cycle 6, median injection time was comparable to in-clinic administration (12 vs 13 minutes), with a 100% completed injection rate and only 1 grade 1 injection-site reaction across 148 at-home injections analyzed."

P3 data • Patient reported outcomes • Multiple Myeloma

Patient-reported Outcomes and Healthcare Provider Perspectives on Subcutaneous Isatuximab Delivery via On-body Injector Versus Manual Injection: Results From the Phase 2 IZALCO Study in Relapsed/Refractory Multiple Myeloma. (PubMed, Clin Lymphoma Myeloma Leuk) - P2 | "These findings support Isa SC OBI as the preferred administration method for patients and HCPs."

Journal • P2 data • Hematological Malignancies • Multiple Myeloma • Oncology • Pain

Evaluation of Patient-Reported Outcomes and Subgroup Analysis with Subcutaneous Isatuximab Delivered via On-Body Injector Compared with Intravenous Delivery from the Phase 3 IRAKLIA Trial (IMS 2026) - P3 | "Introduction: The phase 3 IRAKLIA trial (NCT05405166) assessed isatuximab (Isa) delivered subcutaneously (SC) via an on-body injector (OBI; Isa SC OBI) vs Isa administered intravenously (Isa IV), with pomalidomide and dexamethasone (Pd), in patients (pts) with relapsed/refractory multiple myeloma (RRMM). In satisfied and neutral pt subgroups, more Isa SC OBI pts reported positive experiences vs Isa IV pts. At EOT, pts perceived more benefits than disadvantages with Isa SC OBI than with Isa IV. Our findings support the feasibility of the OBI as a novel method for SC delivery of Isa, in line with results from the overall IRAKLIA cohort."

Clinical • P3 data • Patient reported outcomes • Hematological Malignancies • Multiple Myeloma

Updated Safety of Isatuximab Subcutaneous At-Home Administration by On-Body Injector in Patients with Relapsed/Refractory Multiple Myeloma in the Phase 3 IRAKLIA Study (IMS 2026) - P3 | " In IRAKLIA, patients with RRMM aged ≥18 years with ≥1 prior line of therapy were randomly assigned 1:1 to Isa SC OBI ( 1400 mg; n=263 ) or Isa IV (10 mg/kg; n=268) weekly in Cycle (C)1, then every 2 weeks, + pomalidomide ( 4 mg/day, Day [D]1–21) + dexamethasone (40 mg [20 mg if aged ≥75 years] weekly) in 4-week cycles . Updated data from the ongoing IRAKLIA trial showed that at-home administration by an HCP is feasible and well tolerated. Median injection time and success rate are consistent with in-clinic use. These data support the safety of Isa SC OBI administration at home by an HCP in addition to in the clinic, enabling more flexible, accessible, and comfortable care for patients with multiple myeloma."

Clinical • P3 data • Hematological Disorders • Hematological Malignancies • Multiple Myeloma

Review of Nurse and Pharmacist Survey Evidence on an On-Body Injector and Implications for Isatuximab Subcutaneous via the On-Body Injector in Patients with Multiple Myeloma (IMS 2026) - "Nurses and pharmacists consistently expressed a preference for the preparation and administration of SC OBI vs SC manual injection. Preference was driven by the OBI’s potential for improved efficiency, time savings, a simpler preparation process, flexibility in the preparation location and a reduced risk of needlestick injuries. Limitations of this review include the differences in participant experience with the OBI across studies."

Clinical • Review • Hematological Malignancies • Multiple Myeloma

Safety and Reliability of Isatuximab Subcutaneous On-Body Injector: Results Across the Phase 3 IRAKLIA, Phase 2 IZALCO, and Phase 1B TCD15484 Trials (IMS 2026) - " Pts with RRMM in IRAKLIA (N=263) and the Phase 1b expansion cohort (N=22) received 1400 mg Isa SC OBI plus pomalidomide and dexamethasone (d). In IZALCO, RRMM pts (N=64) received 1400 mg Isa SC OBI + carfilzomib (K)-d...Preinfusion medications included montelukast (C1), steroids, acetaminophen, and H1 antihistamines... These findings support overall low rates of IRRs and ISRs across trials, with >6000 (99.9%) Isa SC OBI injections successfully delivered. Isa SC OBI shows reproducible safety and reliability in IRAKLIA, IZALCO and Phase 1b trials, supporting it as a novel administration option for pts with MM and its potential for future exploration in at-home administration."

Clinical • P1 data • P2 data • P3 data • Hematological Malignancies • Multiple Myeloma

Premedication Use and Infusion-Related Reactions in Patients Treated with Subcutaneous Isatuximab: A Pooled Post Hoc Safety Analysis (IMS 2026) - " Pts with RRMM in IRAKLIA (Isa SC: n=263; Isa IV: n=264) and the Phase 1b TCD15484 trial (Isa SC dose-expansion cohort: n=22; Isa IV: n=12) received 1400 mg Isa SC OBI or 10 mg/kg Isa IV plus pomalidomide and dexamethasone (d). In IZALCO, pts with RRMM (n=74) received 1400 mg Isa SC OBI or manual injection plus carfilzomib (K)-d...Premedications included montelukast (C1 only per protocol), steroids (excluding dexamethasone), acetaminophen, H1 antihistamines, and others...In C2, most pts received 2 unique premedications, acetaminophen (Isa SC: 99.0%; Isa IV: 97.5%) and diphenhydramine (or equivalent) (Isa SC: 91.9%; Isa IV: 93.3%); some pts continued montelukast beyond C1, with use declining each cycle... Isa SC injections without premedication were more frequent than Isa IV injections without premedication, and no IRRs occurred with Isa SC injections delivered without premedications. The results support Isa SC as a safe delivery option with low incidence of IRRs."

Clinical • Retrospective data • Hematological Malignancies • Multiple Myeloma

Patient Experience, Satisfaction and Preference with Isatuximab Subcutaneous On-Body Injector from the Phase 3 IRAKLIA and Phase 2 IZALCO Clinical Trials (IMS 2026) - P2, P3 | "Two key studies evaluated Isa SC OBI in patients with relapsed/refractory multiple myeloma (RRMM): the Phase 3 IRAKLIA trial (NCT05405166) compared Isa SC OBI with Isa intravenous (IV) plus pomalidomide (P) and dexamethasone (d), and the Phase 2 IZALCO trial (NCT05704049) compared Isa SC OBI with SC manual injection plus carfilzomib (K)-d. In IRAKLIA and IZALCO, Isa SC OBI recipients reported less injection discomfort and pain and greater satisfaction vs IV or SC manual injection recipients. The results support positive patient experience with Isa SC OBI in RRMM patients."

Clinical • P2 data • P3 data • Hematological Malignancies • Multiple Myeloma

Longitudinal Analysis of Minimal Residual Disease in the Phase 2 ISASOCUT Study of Subcutaneous Isatuximab-Vrd in Newly Diagnosed Transplant-Ineligible Multiple Myeloma (IMS 2026) - "Bortezomib 1.3 mg/m2 SC, biweekly for cycle 1 then weekly for 11 months. Starting doses cycle 13 onward, isatuximab fixed 1400 mg SC once monthly and lenalidomide 25 mg daily oral route... Updated results from ISASOCUT demonstrate deep and durable responses with Isa SC-VRd in NDMM TI patients, including high MRD-negativity rates and encouraging progression-free survival. Safety was manageable and consistent with the known profile of Isa-VRd. These findings support SC isatuximab as an effective and convenient alternative to intravenous administration and further reinforce Isa-VRd as a standard-of-care option in NDMM TI."

Minimal residual disease • P2 data • Residual disease • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Neutropenia • Thrombocytopenia • Transplantation

Isatuximab Plus Pomalidomide-Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma: Subgroup Analysis by Prior Anti-Cd38 Exposure from the Phase 3 IRAKLIA Trial (IMS 2026) - P3 | "In the Phase 3 IRAKLIA trial (NCT05405166), patients with relapsed/refractory MM (RRMM) received the anti-CD38 monoclonal antibody isatuximab (Isa) subcutaneously (SC) delivered via an innovative on-body injector (OBI) or intravenously (IV), with pomalidomide and dexamethasone (Pd)... Patients with RRMM ≥18 years with ≥1 prior line of therapy including lenalidomide and a proteasome inhibitor were randomized to receive Isa SC OBI (n=263) or Isa IV (n=268) weekly in Cycle 1, then every 2 weeks, with Pd... Isa + Pd demonstrated clinical benefit across anti-CD38–naïve, anti-CD38–exposed, and anti-CD38–refractory patients. A washout period > median of 20.2 mos resulted in outcomes comparable to those in anti-CD38–naïve patients, and outcomes were consistent between anti-CD38–exposed and anti-CD38–refractory patients after a > 9-mo washout period. Efficacy of Isa + Pd in patients with prior anti-CD38 exposure from the IRAKLIA trial presents an opportunity..."

Clinical • P3 data • Hematological Malignancies • Multiple Myeloma

Hematology-Oncologists' Perspectives on an On-Body Injector for Administration of Large-Volume Subcutaneous Drugs: Implications for Isatuximab Subcutaneous for Multiple Myeloma (IMS 2026) - "Heme-oncs who completed hands-on demonstrations with the OBI recognized clinical value, driven primarily by streamlined preparation workflows and hands-free administration capability. Most had a clear preference for the OBI over large-volume SC manual injections. Most expressed confidence in clinic staff's ability to prepare the OBI outside sterile hood environments or by patient chairside."

Hematological Malignancies • Multiple Myeloma

Efficacy and Safety of Isatuximab Subcutaneous Plus Carfilzomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma: Updated Results from the Phase 2 IZALCO Study (IMS 2026) - P2 | "The Phase 3 IRAKLIA trial in relapsed/refractory MM (RRMM) pts demonstrated noninferiority in efficacy and pharmacokinetics of Isa SC delivered via a wearable on-body injector (OBI) in combination with pomalidomide and dexamethasone (Pd) vs Isa IV Pd. These results continue to support the efficacy and safety of Isa SC delivered via manual injection or OBI, plus Kd. Pt satisfaction with Isa SC OBI remained consistently high after pt choice of injection method at C7D1. These efficacy and safety findings are consistent with those reported in the Phase 3 IKEMA study (Isa IV plus Kd)."

Clinical • P2 data • Hematological Malignancies • Multiple Myeloma

Evaluation of Patient-Reported Outcomes and Subgroup Analysis With Subcutaneous Isatuximab Delivered via on-Body Injector Compared With Intravenous Delivery From the Phase 3 IRAKLIA Trial (IMS 2026) - P3 | "Introduction: The phase 3 IRAKLIA trial (NCT05405166) assessed isatuximab (Isa) delivered subcutaneously (SC) via an on-body injector (OBI; Isa SC OBI) vs Isa administered intravenously (Isa IV), with pomalidomide and dexamethasone (Pd), in patients (pts) with relapsed/refractory multiple myeloma (RRMM). In satisfied and neutral pt subgroups, more Isa SC OBI pts reported positive experiences vs Isa IV pts. At EOT, pts perceived more benefits than disadvantages with Isa SC OBI than with Isa IV. Our findings support the feasibility of the OBI as a novel method for SC delivery of Isa, in line with results from the overall IRAKLIA cohort."

Clinical • P3 data • Patient reported outcomes • Hematological Malignancies • Multiple Myeloma

Efficacy and safety of isatuximab subcutaneous (SC) plus carfilzomib and dexamethasone (Isa-Kd) in patients with relapsed/refractory multiple myeloma (RRMM): Results of the phase 2 study IZALCO. (ASCO 2025) - P2 | "Results of a Phase 1b study demonstrated safety and efficacy of Isa SC administration via an on-body delivery system (OBDS; an investigational wearable injector), plus pomalidomide and dexamethasone in RRMM pts. The study met its primary endpoint, demonstrating efficacy and safety of Isa SC administration in combination with Kd, either by manual injection or OBDS. Our study findings are comparable to those reported in the Phase 3 study IKEMA with Isa IV. Pts expressed a clear preference for receiving Isa SC by an OBDS."

Clinical • P2 data • Hematological Malignancies • Multiple Myeloma • Oncology

IRAKLIA: SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM (clinicaltrials.gov) - P3 | N=531 | Active, not recruiting | Sponsor: Sanofi | Trial completion date: Mar 2027 ➔ Oct 2027

Trial completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Isatuximab plus pomalidomide-dexamethasone in relapsed/refractory multiple myeloma: Subgroup analysis by prior anti-CD38 exposure from the phase 3 IRAKLIA trial. (ASCO 2026) - P3 | "In the Phase 3 IRAKLIA trial (NCT05405166), patients with relapsed/refractory MM (RRMM) received the anti-CD38 monoclonal antibody isatuximab (Isa) subcutaneously (SC) delivered via an innovative on-body injector (OBI) or intravenously (IV), with pomalidomide and dexamethasone (Pd)... RRMM patients ≥18 years with ≥1 prior line of therapy including lenalidomide and a proteasome inhibitor were randomized to receive Isa SC (n=263) or IV (n=268) weekly in Cycle 1, then every 2 weeks, with Pd... Isa + Pd demonstrated clinical benefit across anti-CD38–naïve, anti-CD38–exposed, and anti-CD38–refractory patients. A washout period >median of 20.2 mos resulted in outcomes comparable to those in anti-CD38–naïve patients, and outcomes were consistent between anti-CD38–exposed and anti-CD38–refractory patients after a >9-mo washout period. Efficacy of Isa + Pd in patients with prior anti-CD38 exposure from the IRAKLIA trial presents an opportunity to address an..."

P3 data • Hematological Malignancies • Multiple Myeloma

Efficacy and safety of isatuximab subcutaneous plus carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma: results of the Phase 2 study IZALCO. (PubMed, Blood Cancer J) - P2 | "No impact of the SC delivery method was observed on efficacy, safety, pharmacokinetics, and immunogenicity of isatuximab given SC plus Kd, supporting the feasibility of using the OBI as a convenient method for isatuximab SC administration. Clinical trial information: ClinicalTrials.gov NCT05704049."

Journal • P2 data • Hematological Malignancies • Multiple Myeloma • Oncology

Global Access to Multiple Myeloma Medications (GLAMM-2 Study): Access and Barriers to Chemoimmunotherapies and Transplant (ASH 2023) - "Of the therapies listed, 6 were adequately available in LIC and HIC: cyclophosphamide, lenalidomide, pomalidomide, daratumumab, bortezomib, and ASCT (Table 1)...Conclusion While most therapies were available, novel therapies such as isatuximab, ixazomib, selinexor, and elotuzumab were less readily accessible...The financial burden on healthcare is a major limiting factor. USMIRC plans to investigate potential solutions and pursue global collaborative efforts to reduce disparities in therapies."

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Clinical Investigators'Selection of Induction and Maintenance Therapy for Patients With Newly Diagnosed Multiple Myeloma Eligible and Ineligible for Transplant (SOHO 2026) - " For a 65-year-old patient with standard-risk disease who was eligible for transplant, all 20 investigators opted for a 4-drug combination, with 17 of 20 turning to daratumumab (D) in combination with lenalidomide (R), bortezomib (V) and dexamethasone (d) (D-RVd). Among the anti-CD38 antibodies, daratumumab is used almost exclusively, likely because of its subcutaneous administration. However, if subcutaneous isatuximab becomes available, treatment selection may become more diversified. Maintenance therapy is employed for all situations—often indefinitely—and many CIs continue anti-CD38 antibodies in this setting."

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

Subcutaneous Isatuximab Administration By an on-Body Delivery System (OBDS) in Combination with Pomalidomide and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma: Phase 1b Expansion Study Results (ASH 2022) - P1b, P3 | "These updated results with longer follow-up of SC Isa administration via OBDS at the RP2D of 1400 mg showed a safety profile consistent with IV administration, with no IRs, excellent local tolerability and efficacy comparable to that observed in the phase 3 ICARIA study with IV Isa, in combination with Pd. Isa SC administration by OBDS is well tolerated, has a short duration of injection, and provides a convenient hands-free option with controlled delivery. Based on these results and OBDS performance, a non-inferiority phase 3 trial of Isa-SC with OBDS versus Isa-IV is ongoing (NCT05405166)."

Clinical • Combination therapy • P1 data • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Immune Modulation • Infectious Disease • Inflammation • Multiple Myeloma • Neutropenia • Oncology • CD38

Subcutaneous isatuximab administration by an on-body delivery system in combination with pomalidomidedexamethasone in relapsed/refractory multiple myeloma patients: interim phase 1b study results (IMW 2022) - P1b | "Introduction: Intravenous (IV) isatuximab (Isa) + pomalidomide-dexamethasone (Pd) is approved for treatment of relapsed/refractory multiple myeloma (RRMM) patients (pts). SC Isa administered by OBDS shows safety profile consistent with IV administration with no IRs and excellent local tolerability. Efficacy in SC cohorts was comparable to Phase 3 ICARIA results. PK results in OBDS pts were similar to those receiving SC1400."

Clinical • Combination therapy • P1 data • Anemia • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology

Bone Marrow Immune Signatures in Multiple Myeloma Are Linked to Tumor Heterogeneity and Treatment Outcome (ASH 2022) - P3 | "Anti-CD38 monoclonal antibodies increase efficacy when added to standard-of-care (SOC) regimens as reflected by minimal residual disease-negativity (MRD-neg) rates of >50 % after induction therapy in newly diagnosed MM (NDMM) patients treated with SOC plus isatuximab within the GMMG-HD7 trial (Goldschmidt et al...NDMM patients were treated with lenalidomide/bortezomib/dexamethasone (RVd) alone or in combination with isatuximab (isa-RVd, NCT03617731)...BME signatures at baseline and during treatment as defined by our reference atlas enable risk stratifications of MM patients and can identify patients at high risk for early relapse. Longitudinal monitoring of the BME can support clinical decision making, as a compromised CD8+ memory compartment in patients may impact on the efficacy of novel immunotherapies."

Clinical • Heterogeneity • IO biomarker • Bone Marrow Transplantation • Hematological Malignancies • Immunology • Multiple Myeloma • Oncology • Transplantation • CD4 • CD8 • NRAS

ISATUXIMAB SUBCUTANEOUS VIA AN ON-BODY DELIVERY SYSTEM VERSUS ISATUXIMAB INTRAVENOUS, PLUS POMALIDOMIDE AND DEXAMETHASONE, IN RELAPSED/REFRACTORY MULTIPLE MYELOMA: THE RANDOMIZED PHASE 3 IRAKLIA STUDY (EHA 2025) - P3 | "IRAKLIA met its co-primary endpoints, showing efficacy and pharmacokinetic non-inferiority of Isa SC OBDS compared with Isa IV, plus Pd. No new safety signal besides a low ISR incidence was observed, showing excellent tolerability of Isa SC OBDS. Far fewer infusion reactions and a higher patient satisfaction were also noted for Isa SC OBDS compared with Isa IV."

Clinical • P3 data • Hematological Malignancies • Multiple Myeloma • Oncology

Safety and Reliability of Isatuximab Subcutaneous On-Body Injector: Results Across the Phase 3 IRAKLIA, Phase 2 IZALCO, and Phase 1b TCD15484 Trials (SOHO 2026) - " Patients with RRMM in IRAKLIA (N = 263) and the phase 1b expansion cohort (N = 22) received 1400 mg Isa SC OBI plus pomalidomide and dexamethasone (d). In IZALCO, RRMM patients (N = 64) received 1400 mg Isa SC OBI plus carfilzomib-dexamethasone... These findings support overall low, self-limiting rates of IRRs and ISRs across trials, with >6000 (99.9%) Isa SC OBI injections successfully delivered. Isa SC OBI shows reproducible safety and reliability in the IRAKLIA, IZALCO, and phase 1b trials, supporting it as a novel administration option for MM patients and its potential for future exploration in at-home administration."

Clinical • P1 data • P2 data • P3 data • Hematological Malignancies • Multiple Myeloma • Oncology