RegulationPriority Review (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea), Orphan Drug (Australia)

Structure/Sequence

Sequence Code 9075908L

Source: *****

Sequence Code 9075927H

Source: *****

Clinical Trials associated with Isatuximab-IRFC

NCT06832865

/ Not yet recruitingPhase 2IIT

A Phase 2 Study of Elranatamab in Combination With Isatuximab (ELISA) in Relapsed and Refractory Multiple Myeloma

This is an open-label phase 2 study of elranatamab in combination with isatuximab administered subcutaneously in patients with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior lines of therapy and who have had previous treatment with both immunomodulatory drugs (IMiDs) and a proteasome inhibitor (PI). The subcutaneous injection method of isatuximab administration, including the device used to administer isatuximab, is investigational.

Start Date01 Aug 2026

Sponsor / Collaborator

The Massachusetts General Hospital

[+2]

NCT06517017

/ Not yet recruitingPhase 2IIT

Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma: A Phase 2 Multicenter Study

Historically, the frailest patients with multiple myeloma are under-represented in clinical trials, and have very high rates of treatment discontinuation, and early treatment mortality. The investigators hypothesize that a go-slow gentle approach to starting treatment in such patients, starting with just Isatuximab and dexamethasone with a gentle introduction to lenalidomide third cycle onwards, may improve treatment adherence and quality of life. The goal of this clinical trial is to learn if a go-slow approach to treating MM in ultra-frail patients may improve the ability to adhere to treatment and improve quality of life.

Start Date01 May 2025

Sponsor / Collaborator

University of Utah

[+1]

NCT06762769

/ Not yet recruitingPhase 2IIT

Isatuximab and Iberdomide As Immunotherapy for High Risk in Smouldering Myeloma

The study will test a new combination of 3 drugs: Isatuximab (Isa), Iberdomide (Iber) and Dexamethasone (Dex), in patients who have intermediate or high risk smouldering myeloma. Smouldering myeloma is an early form of myeloma which may progress to active multiple myeloma, but at a slow rate. Patients with smouldering myeloma do not usually receive any treatment but will have regular check-ups and observation. Some patients have a diagnosis of smouldering myeloma which has a higher risk of progressing to active myeloma.
The study will test if the combination of drugs is effective at preventing or delaying the disease progressing into active multiple myeloma. The study will also test if the combination is tolerated and accepted by patients.

Start Date31 Mar 2025

Sponsor / Collaborator

University College London

[+2]

100 Clinical Results associated with Isatuximab-IRFC

100 Translational Medicine associated with Isatuximab-IRFC

100 Patents (Medical) associated with Isatuximab-IRFC

439

Literatures (Medical) associated with Isatuximab-IRFC

03 Jun 2025·JOURNAL OF CLINICAL ONCOLOGY

Isatuximab Subcutaneous by On-Body Delivery System vs Isatuximab Intravenous Plus Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Phase 3 IRAKLIA Study.

Article

Author: Suzan, Florence ; Koch, Victorine ; Li, Fei ; Dimopoulos, Meletios-Athanasios ; Schjesvold, Fredrik ; LeBlanc, Richard ; Sémiond, Dorothée ; Leleu, Xavier ; Lu, Jin ; Goldschmidt, Hartmut ; Li, Chunrui ; Custidiano, Maria Del Rosario ; Zhang, Rick ; Stefanova-Urena, Maya ; Hus, Marek ; Ling, Silvia ; Ailawadhi, Sikander ; Gomez, Cesar ; Oriol, Albert ; Spencer, Andrew ; Cerchione, Claudio ; Parmar, Gurdeep ; Mateos, Maria Victoria ; Buck, Tondre T ; Hungria, Vania ; Moreau, Philippe ; Ishida, Tadao ; Beşışık, Sevgi Kalayoğlu ; Špička, Ivan ; Minařík, Jiří ; Berkovits, Alejandro ; Rajnics, Péter

PURPOSE:

To report results of the multicenter, open-label IRAKLIA trial (NCT05405166) of isatuximab subcutaneous (SC) versus intravenous (IV), plus pomalidomide and dexamethasone, in relapsed/refractory multiple myeloma (MM), the first Phase 3 MM trial using an on-body delivery system (OBDS).

METHODS:

Patients with ≥1 prior line of therapy were randomized 1:1 to isatuximab OBDS (1400 mg) or IV (10 mg/kg) weekly in Cycle (C)1, then every 2 weeks, plus pomalidomide (4 mg/day, Day [D]1-21) and dexamethasone (40 mg weekly [age ≥75: 20 mg]) and treated until progression, unacceptable toxicity, or patient request. Co-primary endpoints were overall response rate (ORR; non-inferiority margin, 0.839) and isatuximab C_trough (C6D1 predose; non-inferiority margin, 0.8). Non-inferiority of OBDS versus IV was demonstrated if both co-primary endpoints achieved non-inferiority.

RESULTS:

IRAKLIA randomized 531 patients (OBDS, n=263; IV, n=268). After 12 months median follow-up, ORR was 71.1% (OBDS) and 70.5% (IV; relative risk [95% CI]=1.008 [0.903-1.126]; lower CI exceeded non-inferiority margin). Mean (SD) C6D1 C_trough was 499 (259) μg/mL (OBDS) and 340 (169) μg/mL (IV). C_trough geometric mean ratio (90% CI) was 1.532 (1.316-1.784); lower CI exceeded non-inferiority margin. Grade ≥3 treatment-emergent adverse event incidences were 81.7% (OBDS) and 76.1% (IV); infusion reaction incidences were 1.5% and 25.0%. Injection site reactions occurred in 0.4% of OBDS injections (all grade 1-2); 99.9% of injections completed without interruption.

CONCLUSION:

IRAKLIA demonstrated efficacy and pharmacokinetic non-inferiority between isatuximab OBDS and IV. No unexpected safety signal was observed, with excellent local tolerability of isatuximab OBDS. Efficacy and safety were comparable to isatuximab IV in ICARIA-MM, except the lower OBDS infusion reaction rate. These results support potential use of the OBDS, designed to improve practice efficiency.

03 Jun 2025·NEW ENGLAND JOURNAL OF MEDICINE

Measurable Residual Disease-Guided Therapy in Newly Diagnosed Myeloma.

Article

Author: Avet-Loiseau, Hervé ; Rey, Philippe ; Arnulf, Bertrand ; Perrot, Aurore ; Lambert, Jérôme ; Touzeau, Cyrille ; Escoffre-Barbe, Martine ; Leleu, Xavier ; Macro, Margaret ; Moreau, Philippe ; Hulin, Cyrille ; Gounot, Romain ; Schiano, Jean-Marc ; Gay, Julie ; Mary, Jean-Yves ; Chaleteix, Carine ; De Prijck, Bernard ; Pieragostini, Andrea ; Garderet, Laurent ; Manier, Salomon ; Braun, Thorsten ; Corre, Jill ; Mohty, Mohamad ; Mariette, Clara ; Chalopin, Thomas ; Karlin, Lionel

BACKGROUND:

Measurable residual disease (MRD) is a major prognostic factor in newly diagnosed multiple myeloma. An assessment of an MRD-guided consolidation strategy in patients who are eligible for autologous stem-cell transplantation (ASCT) may be useful.

METHODS:

In this phase 3 trial, we randomly assigned transplantation-eligible patients with newly diagnosed myeloma who had completed induction therapy with isatuximab, carfilzomib, lenalidomide, and dexamethasone (Isa-KRd) to receive consolidation therapy according to their MRD status. Patients who were MRD-negative at 10^-5 sensitivity (i.e., <1 cancer cell per 100,000 normal cells, as assessed by next-generation sequencing were assigned to undergo ASCT and receive Isa-KRd for two cycles (ASCT group) or to receive Isa-KRd for six cycles (Isa-KRd group). Patients who were MRD-positive at 10^-5 sensitivity were assigned to undergo tandem ASCT (two ASCTs within a short period; tandem ASCT group) or to undergo ASCT and receive Isa-KRd for two cycles (single ASCT group). The primary end point was an MRD-negative status at 10^-6 sensitivity before maintenance therapy.

RESULTS:

Among 485 patients who were MRD-negative at 10^-5 sensitivity after induction, a premaintenance MRD-negative status at 10^-6 sensitivity occurred in 86% in the ASCT group and in 84% in the Isa-KRd group (adjusted relative risk, 1.02; 95% confidence interval [CI], 0.95 to 1.10; P = 0.64). Among 233 patients who were MRD-positive at 10^-5 sensitivity after induction, a premaintenance MRD-negative status at 10^-6 sensitivity occurred in 32% in the tandem ASCT group and in 40% in the single ASCT group (adjusted relative risk, 0.82; 95% CI, 0.58 to 1.15; P = 0.31); 15% of the patients in the tandem ASCT group did not undergo a second ASCT. During consolidation, disease progression occurred in 5 patients and death unrelated to disease progression occurred in 2 patients - all were in the Isa-KRd or tandem ASCT groups. No new safety signals were observed. The median follow-up was 16.8 months in the ASCT and Isa-KRd groups and 16.3 months in the tandem ASCT and single ASCT groups.

CONCLUSIONS:

Among patients who were MRD-negative at 10^-5 sensitivity after induction, the percentage with a premaintenance MRD-negative status at 10^-6 sensitivity was not significantly higher with ASCT than with Isa-KRd. Among patients who were MRD-positive status at 10^-5 sensitivity after induction, the percentage with a premaintenance MRD-negative status at 10^-6 sensitivity was not significantly higher with tandem ASCT than with single ASCT. (Funded by Intergroupe Francophone du Myélome and others; MIDAS ClinicalTrials.gov number, NCT04934475.).

01 Jun 2025·JCO Global Oncology

Global Access to Multiple Myeloma Therapies

Article

Author: Ayoobkhan, MD Fathima Shehnaz ; Atrash, Shebli ; McGuirk, Joseph P. ; Desai, Nihar ; Mushtaq, Muhammad Umair ; Naeem, Menahil ; Saif, Md Saiful Islam ; Logan, Emerson ; Mammadzadeh, Aytaj ; Anwer, Faiz ; Mohamed, Benlazar ; Mahmoudjafari, Zahra ; Hashmi, Shahrukh K. ; Hammad, Nada ; Abdallah, Al-Ola ; Ahmed, Nausheen ; Rana, Shabeeha ; Atallah, Rawan ; Shatnawi, Yara ; Popat, Rakesh ; Carneiro, Thiago Xavier

PURPOSE:

Initial reports indicate that access to contemporary therapies currently used in North America for the treatment of multiple myeloma (MM) varies internationally. No studies have quantitatively reported the extent of disparities in the access to MM therapies worldwide, with a goal to investigate access to MM therapies and barriers globally.

METHODS:

From June 18 to July 15, 2023, an electronic survey was distributed to 176 oncologists treating MM outside the United States. MM drugs were categorized by accessibility, with the cutoff for adequate access set at 60% of respondents affirming easy/moderate access.

RESULTS:

Ninety-five (54%) respondents from 33 countries completed the survey. Fifty-one percent of the respondents were from university-based academic programs, and 17% of the responders treated only plasma cell disorders. Most respondents had adequate access to noncellular MM therapies, except for isatuximab, ixazomib, selinexor, and elotuzumab. Among the cellular therapies, 17% had access to Chimeric Antigen Receptor T-cell therapy, whereas 23% had access to approved T-cell engagers (TCEs). Financial stress on patients and health care systems has emerged as a primary barrier to global inaccessibility of treatment drugs.

CONCLUSION:

Global access to novel MM therapies remains challenging, and we have identified barriers and suggested strategies to bridge this gap.

224

News (Medical) associated with Isatuximab-IRFC

03 Jun 2025

·www.globenewswire.com

Press Release: ASCO: new Sarclisa data support subcutaneous administration with on-body injector

ASCO: new Sarclisa data support subcutaneous administration with on-body injector New data from two clinical studies demonstrated that Sarclisa administered subcutaneously via an investigational on-body injector shortened treatment time to minutes with similar efficacy and safety compared to intravenous infusionStudies used Enable Injections’ enFuse® on-body injector, an automated hands-free injectorData will form the basis of global regulatory submissions across all currently approved lines of treatment Paris, June 3, 2025. New data from two clinical studies of the investigational use of Sarclisa administered subcutaneously (SC) via an on-body injector (OBI) (also referred to as an on-body delivery system) in relapsed or refractory multiple myeloma (R/R MM) support the potential use of this innovative delivery method to advance patient care, while upholding Sarclisa’s efficacy and safety profile. The results were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting and include full data from the IRAKLIA phase 3 study, the first to incorporate the use of an OBI in the treatment of MM, and demonstrate non-inferior efficacy and pharmacokinetics compared to Sarclisa intravenous (IV) infusion. Alyssa Johnsen, MD, PhDGlobal Therapeutic Area Head, Immunology and Oncology Development “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.” The OBI offers the potential to improve the overall patient experience in MM treatment. Recent studies and surveys suggest the use of an OBI may be associated with greater convenience, flexibility, and patient satisfaction compared to IV or manual SC administration methods.1 In addition, an OBI may also streamline the administration process for providers, potentially reducing the physical burden on nurses and enabling them to possibly move freely through the use of a hands-free device while monitoring the patient during injection. The IRAKLIA phase 3 study and the IZALCO phase 2 study presented at ASCO were conducted using Enable Injections’ enFuse® hands-free OBI, an automated injector designed to subcutaneously administer high-volume medicines beginning with the click of a button, to administer the hyaluronidase-free SC formulation of Sarclisa. The enFuse device uses a 30 gauge, hidden, and retractable needle that is smaller compared to some of the commonly used large-volume SC injection needles, which may support patient comfort. The safety and efficacy of Sarclisa SC administered with the OBI or manual administration are investigational and have not been approved for use by any regulatory authority. IRAKLIA phase 3 study IRAKLIA is a global, randomized, open-label, pivotal phase 3 non-inferiority study comparing Sarclisa SC administered via an OBI and Sarclisa IV, both in combination with pomalidomide and dexamethasone (Pd) in adult patients with R/R MM who have received at least one prior line of treatment. At the data cut-off of November 6, 2024, and a median follow-up of 12 months, the study demonstrated: Primary endpoints Objective response rate (ORR) with Sarclisa SC-Pd was 71.1% compared to 70.5% with Sarclisa IV-Pd, establishing non-inferiority (risk ratio [RR] 1.008; 95% confidence interval [CI]: 0.903-1.126; p=0.0006).Observed Sarclisa mean (standard deviation [SD]) concentration before dosing (C trough) at steady state (C6D1 pre-dose) with Sarclisa SC-Pd was 499 (259) ug/mL compared to 341 (169) ug/mL with Sarclisa IV-Pd, establishing non-inferiority (geometric mean ratio [GMR] 1.532; 90% CI: 1.316-1.784). Secondary endpoints Very good partial response (VGPR) or better rates were consistent between Sarclisa SC-Pd and Sarclisa IV-Pd at 46.4% and 45.9%, respectively (RR 1.011; 95% CI: 0.841-1.215; p<0.0001).Observed Sarclisa mean (SD) C trough at 4 weeks (C2D1 pre-dose) with Sarclisa SC-Pd was 421 (215) ug/mL compared to 302 (117) ug/mL with Sarclisa IV-Pd (GMR 1.302; 90% CI 1.158-1.465).Systemic infusion reactions (IR) were significantly lower with Sarclisa SC-Pd, occurring in only 1.5% of patients compared to 25% of those treated with Sarclisa IV-Pd (RR: 0.061; 95% CI: 0.022-0.164; p<0.0001). Of note, nearly all IRs occurring were grade 1 or 2 and resolved within one day. No patients in the Sarclisa SC-Pd arm discontinued treatment due to a systemic IR.Most Sarclisa SC-Pd-treated patients (70%) reported being satisfied or very satisfied with their injection compared to 53.4% in the Sarclisa IV-Pd arm, demonstrating the positive impact of this innovative method of administration on the patient experience (OR 2.036; 95% CI: 1.425-2.908; p=0.0001).99.9% of Sarclisa SC OBI injections were successfully delivered with no significant safety concerns related to the OBI.Progression-free survival (PFS) rates at 12 months were also similar, reaching 66.1% for patients treated with Sarclisa SC-Pd compared to 65.1% of patients treated with Sarclisa IV-Pd (HR 0.985; 95% CI: 0.726-1.338). The overall safety profile of Sarclisa SC-Pd observed in this study was consistent with the established safety profile of Sarclisa IV-Pd, but with a notably lower rate of systemic IRs. No new safety concerns were observed, except for low-grade local injection site reactions (ISRs) associated with SC administration that occurred with a low incidence (0.4%, n=19/5,145 injections). Nearly all ISRs were grade 1, except for one episode of grade 2. Xavier Leleu, MD, PhDHead of the Department of Hematology and Myeloma Clinic at the Hôpital La Mileterie and study investigator“Results from the IRAKLIA phase 3 study represent a potentially transformational advancement in the administration of multiple myeloma treatment. These data not only establish non-inferiority between Sarclisa administered both subcutaneously and intravenously across several key endpoints but reinforce the positive impact that this on-body injector could have on the patient treatment experience, as demonstrated by patient satisfaction scores.” In addition to the oral presentation at ASCO, the full data were simultaneously published in the Journal of Clinical Oncology. IZALCO phase 2 studyIn addition to the IRAKLIA phase 3 study, Sanofi also presented new data from the randomized, sequential, open-label, IZALCO phase 2 study evaluating the efficacy and safety of Sarclisa SC administered via manual push or an OBI, in combination with carfilzomib and dexamethasone (Kd) in adult patients with R/R MM who have received one to three prior lines of therapy. At a median follow-up of 10.1 months, the study demonstrated: ORR was 79.7% in patients treated with Sarclisa SC-Kd (95% CI: 68.8-88.2) validating the prespecified efficacy hypothesis. With a median follow-up of 10 months, VGPR or better rate in patients treated with Sarclisa SC-Kd was 62.2% and complete response (CR) or better rate was 21.6%.Only two patients treated with Sarclisa SC-Kd, or 2.7% of recipients, experienced a grade 2 or lower IR event with manual injection and no IR event occurred with OBI administration; approximately 1% of injections were associated with a local ISR.After treatment with both methods, most patients (74.5%) preferred the OBI versus 17% who preferred manual injection and 8.5% with no preference (p=0.0004; binomial test against the null hypothesis of ≤50% rate). The overall safety profile of Sarclisa SC-Kd observed in this study was consistent with the established safety profile of Sarclisa IV-Kd, with no new safety concerns observed. Advancing patient and provider-centric innovation in MM While SC administration is currently available for certain MM treatment regimens through a manual injection, administering large-volume medicines manually can present significant challenges, including a labor-intensive process for nurses, risk of strain and needlestick injuries, and potential need for larger needles that may compromise patient comfort and increase anxiety. Mehul Desai, PharmD, MBAVice President, Medical Affairs, Enable Injections “We believe multiple myeloma patients deserve a more convenient and comfortable treatment experience and recognize the crucial role providers play in delivering that care. Through our collaboration with Sanofi, we’ve aspired to advance an on-body injector that could transform the treatment experience for patients and providers alike. The results from the IRAKLIA and IZALCO studies represent a significant step toward our ambition and validate the potential of the on-body injector to deliver the same high standard of efficacy established with intravenous Sarclisa.” In addition to IRAKLIA and IZALCO, Sanofi is also evaluating Sarclisa SC administration via an OBI in the front-line treatment setting. The ISASOCUT phase 2 study conducted by the University of Poitiers, is evaluating Sarclisa in combination with bortezomib, lenalidomide and dexamethasone (VRd) in adult patients with newly diagnosed MM (NDMM) not eligible for autologous stem-cell transplant (ASCT), while the German-speaking Myeloma Multicenter Group (GMMG)-HD8 phase 3 study, conducted in collaboration with the GMMG and the German Multiple Myeloma Study Group Consortium (DSMM), is evaluating Sarclisa SC-VRd induction in NDMM patients who are eligible for ASCT. In addition, results from the IZALCO, IRAKLIA and ISASOCUT studies will be presented at the European Hematology Association Congress later this month. The IRAKLIA abstract was also hand-selected to be included in the 2025 Best of ASCO program, held later in the summer of 2025, following the ASCO Annual Meeting. The data from these studies, collectively, will form the basis for global regulatory submissions. Sarclisa administered subcutaneously via the on-body injector or manual administration is investigational and has not been approved for any use by any regulatory authority. The safety and efficacy of this formulation and delivery method have not been established. About the IRAKLIA and IZALCO studiesIRAKLIA is a randomized, open-label, pivotal phase 3 study evaluating the non-inferiority of Sarclisa SC formulation administered at a fixed dose SC via an OBI versus weight-based dosed Sarclisa IV in combination with Pd in adult patients with R/R MM who have received at least one prior line of therapy. The co-primary outcomes being assessed are ORR, defined as the proportion of patients with stringent CR, CR, VGPR, and partial response (PR) according to the 2016 IMWG criteria assessed by Independent Review Committee (IRC), and observed C trough at steady state (pre-dose at C6D1), defined as observed Sarclisa plasma concentrations. IZALCO is a two-part, randomized, sequential, open-label, phase 2 study evaluating the efficacy and safety of Sarclisa SC formulation administered SC via manual push or an OBI in adult patients with R/R MM who have received one to three prior lines of therapy. The primary objective is ORR, as assessed by IRC. The secondary objective is patient preference for the OBI versus manual administration of Sarclisa SC. About Enable Injections Based in the US (Cincinnati, OH), Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of enFuse. enFuse is an innovative wearable drug delivery platform that is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics. For more information, visit https://enableinjections.com. About SarclisaSarclisa (isatuximab) is approved in more than 50 countries, including in the US, EU, Japan, and China, across multiple treatment lines for MM. Based on the ICARIA-MM phase 3 study, Sarclisa is approved in the US, EU and Japan in combination with Pd for the treatment of patients with R/R MM who have received ≥two prior therapies, including lenalidomide and a proteasome inhibitor and have relapsed on the last therapy; this combination is also approved in China for patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. Based on the IKEMA phase 3 study, Sarclisa is also approved in more than 50 countries in combination with carfilzomib and dexamethasone, including in the US for the treatment of patients with R/R MM who have received one to three prior lines of therapy and in the EU for patients with MM who have received at least one prior therapy. In the US, EU, UK, and China, Sarclisa is approved in combination with VRd as a front-line treatment option in transplant-ineligible NDMM patients, based on the IMROZ phase 3 study. In Japan, Sarclisa is approved in combination with VRd as a front-line treatment option regardless of transplant eligibility. At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need. For more information on Sarclisa clinical studies, please visit www.clinicaltrials.gov. About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com Victor Rouault | +33 6 70 93 71 40 | victor.rouault@sanofi.comTimothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com Investor RelationsThomas Kudsk Larsen |+44 7545 513 693 | thomas.larsen@sanofi.com Alizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.comFelix Lauscher | +1 908 612 7239 | felix.lauscher@sanofi.com Keita Browne | +1 781 249 1766 | keita.browne@sanofi.comNathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.comTarik Elgoutni | +1 617 710 3587 | tarik.elgoutni@sanofi.com Thibaud Châtelet | +33 6 80 80 89 90 | thibaud.chatelet@sanofi.com Yun Li | +33 6 84 00 90 72 | yun.li@sanofi.com Sanofi forward-looking statementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this press release are the property of the Sanofi group with the exception of enFuse. Attachment Press Release

Phase 3Clinical ResultDrug ApprovalPhase 2ASCO

03 Jun 2025

·www.fiercepharma.com

ASCO: Sanofi shows investigational Sarclisa SC, delivered by on-body device, measures up to its IV formulation

Sanofi is working to gain approval of its subcutaneous version of multiple myeloma treatment Sarclisa, delivered by way of an on-body injector. Though they are both multiple myeloma drugs with the same mechanism of action, Sanofi’s Sarclisa has had difficulty competing with Johnson & Johnson’s powerhouse Darzalex, largely because it reached the market five years later.But one advancement that could help Sanofi close some of the gap is its on-body delivery system for its CD38 antibody.Tuesday, at the American Society of Clinical Oncology annual meeting in Chicago, Sanofi presented data from two trials that showed Sarclisa administered subcutaneously (SC) from an investigational on-body injector (OBI) reduced treatment time and produced similar efficacy and safety compared to intravenous (IV) infusion.These are the first two studies to test the use of an OBI in the treatment of multiple myeloma. The company added that the trials will back regulatory submissions in the first half of this year.“We believe the novel on-body injector represents a significant innovation that could improve and streamline the treatment process for both patients and providers,” Alyssa Johnsen, M.D., Ph.D., Sanofi’s global head of immunology and oncology development, said in a release.In the phase 3 IRAKLIA noninferiority study for patients who had received at least one prior line of treatment, Sarclisa SC in combination with pomalidomide and dexamethasone (Pd) provided a 71.1% objective response rate (ORR) compared to 70.5% ORR for Sarclisa IV-Pd with a 12 month follow-up.In the phase 2 IZALCO trial in multiple myeloma patients who had received at least one line of prior therapy, Sarclisa SC administered by way of a manual push or an OBI, in combination with carfilzomib and dexamethasone (Kd), delivered an 80% ORR, which validated the study’s prespecified efficacy hypothesis, Sanofi said.In both studies, Sanofi’s SC version was consistent with the established safety profile of Sarclisa IV. The subcutaneous formulation of Sarclisa is delivered by Enable Injections’ enFuse automated device, which gained its first FDA approval two years ago as an on-body delivery system for Apellis Pharmaceuticals’ paroxysmal nocturnal hemoglobinuria drug Empaveli.Patient comfort is enhanced by a 30-gauge retractable needle that is smaller than some of the large-volume SC injection needles, Sanofi said.While Sarclisa’s SC formulation has yet to be approved, J&J gained its SC nod for Darzalex Faspro in 2020, which has helped build its sales to $11.7 billion in 2024, compared to $471 million for Sarclisa. Darzalex was originally approved as a second-line treatment for multiple myeloma in 2015, while Sarclisa answered with its first nod in 2020. Darzalex gained its first-line nod in 2019, while Sarclisa answered with its first-line approval last year. The manual injection of large-volume treatments—such as Sarclisa and Darzalex—can “present significant challenges,” Sanofi said, adding that it is a labor-intensive process for nurses, with an added risk of “strain and needlestick injuries.” When larger needles are used, it can compromise patient comfort, the company added. Sanofi also is investigating Sarclisa SC administration by way of an OBI in newly diagnosed multiple myeloma patients.

Clinical ResultDrug ApprovalPhase 3ASCO

03 Jun 2025

·firstwordpharma.com

ASCO25: Sanofi details Sarclisa on-body injector data as it chases after Darzalex's lead

Sanofi presented positive clinical data Tuesday for a subcutaneous (SC) formulation of its multiple myeloma drug Sarclisa (isatuximab) at the American Society of Clinical Oncology (ASCO) annual meeting, offering hope for the French drugmaker's efforts to grab more market share from Johnson & Johnson's dominant Darzalex (daratumumab) franchise.While Darzalex generated $11.7 billion in sales last year compared to Sarclisa's $471 million, the new data suggest Sanofi's SC approach – using an on-body injector – could help level the playing field in a market for CD38-targeting drugs that Sanofi estimates will reach €16 billion ($18.2 billion) by 2030 (see – Spotlight On: J&J's Darzalex joins the $10 billion club).The Phase III IRAKLIA study, toplined earlier this year, showed that Sarclisa administered subcutaneously via Enable Injections' enFuse on-body injector achieved a 71.1% objective response rate (ORR) after a median follow-up of 12 months, compared to 70.5% for the current intravenous (IV) formulation, meeting the non-inferiority primary endpoint. IRAKLIA tested both versions in combination with pomalidomide and dexamethasone in adult patients with relapsed/refractory multiple myeloma who have received at least one prior line of treatment.Thin, retractable needleThe automated hands-free device uses a 30-gauge hidden and retractable needle that is thinner than commonly used SC injection needles. Sanofi said systemic infusion reactions in the study dropped significantly to just 1.5% of patients receiving the SC formulation versus 25% for IV administration.Patient satisfaction scores also favoured the SC approach, with 70% reporting they were satisfied or very satisfied compared to 53.4% for IV treatment. Progression-free survival rates at 12 months were similar between the two formulations at 66.1% and 65.1%, respectively.Meanwhile, data from the Phase II IZALCO study evaluating Sarclisa SC via manual push or an on-body injector in combination with carfilzomib and dexamethasone in patients who had received one to three prior lines of therapy showed a 79.7% ORR. When comparing delivery methods within the SC approach, 74.5% of patients preferred the on-body injector whereas only 17% favoured manual injection.Darzalex's five-year lead "We believe the novel on-body injector represents a significant innovation that could improve and streamline the treatment process for both patients and providers," said Alyssa Johnsen, Sanofi's global therapeutic area head for immunology and oncology development. The company has said the first regulatory submissions are expected this half.Sanofi's subcutaneous programme received financial backing from Blackstone Life Sciences, which committed up to €300 million ($341 million) in 2022 through a risk-sharing agreement that makes the investment firm eligible for royalties on future subcutaneous sales.The drugmaker is looking to challenge J&J's market domination in multiple myeloma with Darzalex, which was first approved in 2015. An SC version of J&J's drug, that uses Halozyme's ENHANZE drug-delivery technology and is sold under the name Darzalex Faspro (daratumumab/hyaluronidase-fihj), has been cleared since 2020. Unlike Darzalex Faspro, Sarclisa SC is hyaluronidase-free.Last month, an FDA advisory panel recommended that Darzalex Faspro be approved for a new indication – high-risk smouldering multiple myeloma.Despite J&J's head start, Brian Foard, Sanofi's head of specialty care, expressed confidence during a January earnings call in Sarclisa SC's competitive prospects. "We absolutely do not think it's too late. We absolutely believe we have all of the elements we need now to compete in the marketplace," Foard said. "We are investing behind this asset as we said before, and we believe it's going to be a multi blockbuster."

Clinical ResultDrug ApprovalPhase 3ASCOPhase 2

100 Deals associated with Isatuximab-IRFC

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KEGG	Wiki	ATC	Drug Bank
-	Isatuximab-IRFC	L01	DB14811

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Relapse multiple myeloma	Japan	Sanofi KK	29 Jun 2020
Multiple Myeloma	United States	Sanofi-Aventis U.S. LLC	02 Mar 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Residual Neoplasm	Phase 3	Belgium	Amgen, Inc.	08 Dec 2021
Residual Neoplasm	Phase 3	Belgium	Sanofi	08 Dec 2021
Residual Neoplasm	Phase 3	Belgium	Bristol Myers Squibb Co.	08 Dec 2021
Residual Neoplasm	Phase 3	France	Sanofi	08 Dec 2021
Residual Neoplasm	Phase 3	France	Amgen, Inc.	08 Dec 2021
Residual Neoplasm	Phase 3	France	Bristol Myers Squibb Co.	08 Dec 2021
Residual Neoplasm	Phase 3	Réunion	Bristol Myers Squibb Co.	08 Dec 2021
Residual Neoplasm	Phase 3	Réunion	Amgen, Inc.	08 Dec 2021
Residual Neoplasm	Phase 3	Réunion	Sanofi	08 Dec 2021
Smoldering Multiple Myeloma	Phase 3	United States	Sanofi-Aventis Deutschland GmbH	16 Jun 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05405166 (IRAKLIA, Company_Website) Manual	Phase 3	Multiple Myeloma	-	Sarclisa SC + pomalidomide + dexamethasone	nsiittdint(uknpoiotfx) = met its co-primary endpoints of non-inferior objective response rate (ORR) and observed concentration before dosing (C trough). qonqdzhnwm (lfowdtkoyx ) Met View more	Positive	09 Jan 2025
				Sarclisa IV + pomalidomide + dexamethasone
NCT04939844 (REST, ASH2024) Manual	Phase 2	Multiple Myeloma First line	51	Isatuximab+Bortezomib+Lenalidomide+Dexamethasone	sfxuxhjeyo(pfvfpmenuj) = glxkprxcrr mxwuiecnfm (ebnqjynytk ) View more	Positive	09 Dec 2024
NCT03319667 (IMROZ, ASH2024) Manual	Phase 3	Multiple Myeloma First line	446	Isatuximab, Bortezomib, Lenalidomide, and Dexamethasone (Isa-VRd)	iszferyamb(vsqknstjom) = fociqfccqo qqxlflokaq (mlimqumlbs ) View more	Positive	09 Dec 2024
				Bortezomib, Lenalidomide, and Dexamethasone (VRd)	iszferyamb(vsqknstjom) = etmukalext qqxlflokaq (mlimqumlbs ) View more
ASH2024 Manual	Not Applicable	Refractory Multiple Myeloma	83	isatuximab + pomalidomide + dexamethasone	pkpxcguwpa(jnxetkrmsd) = sceesbisyt nhcpkqawwp (wymezqgdfg ) View more	Positive	08 Dec 2024
				isatuximab + pomalidomide + dexamethasone (patients with intraosseous components)	yumvxycrli(tavrnmafmw) = stpqvuutvp bomcjqopkp (bohnejjkyg ) View more
NCT02332850 (ASH2024) Manual	Phase 2	Multiple Myeloma	50	IsatuximabCarfilzomibDexamethasone	vmmdhnqjkc(ldputurfge) = vsyzbwfyfv najrvxppaq (ubhydwqiki ) View more	Positive	07 Dec 2024
NCT03319667 (IMROZ, Pubmed \| N Engl J Med)	Phase 3	Multiple Myeloma First line	446	Isatuximab plus VRd	cecknkxzsw(muhqcsovah) = ozszvssioc usizubfmhx (ckconqohxs ) View more	Positive	31 Oct 2024
				VRd alone	cecknkxzsw(muhqcsovah) = zedbvlmfnh usizubfmhx (ckconqohxs ) View more
NCT04083898 (Pubmed \| Ann Hematol) Manual	Phase 1	Multiple Myeloma	15	Isatuximab bendamustineprednisone	mgmbrioyeg(mkglfferjh) = komihwwjzb ogsvbfferv (ccsswqcelk ) View more	Positive	04 Sep 2024
NCT04661033 (CTgov)	Phase 2	Warm autoimmune hemolytic anemia	8	Isatuximab SAR650984 (Part A: Cohort 1: Isatuximab 140 mg SC Q2W x2)	jsdlookrea = huljwrjaod uwuxidmpyb (oruhmvotvb, zykrtfxzry - qjloahcljh) View more	-	27 Aug 2024
				Isatuximab SAR650984 (Part A: Cohort 2: Isatuximab 280 mg SC Q2W x6)	jsdlookrea = onhbixywqa uwuxidmpyb (oruhmvotvb, pjjilfafwy - jymqtvhbui) View more
NCT04751877 (BENEFIT \| IFM2020-05, ASCO 12024 \| ASCO 22024) Manual	Phase 3	Multiple Myeloma First line	270	overall	gttdcqsmhq(qfbzajulgp) = snckhjzmdt iinjfoxddv (szplotbqle ) View more	Superior	24 May 2024
				Isatuximab (IlenalidomidealidexamethasonexambortezomibRd) with bortezomib	ypsmuzrvnp(uovztnzncv) = zpqsqkmjyu ukutwmmlik (oynzbrrmxw ) View more

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