anitocabtagene autoleucel (CART-ddBCMA) / Arcellx, Gilead - LARVOL DELTA

Gilead and Kite Showcase Continued Progress in Transforming Blood Cancer Care With New Cell Therapy Data at ASH 2025 (Businesswire) - "Updated Results from Phase 2 Pivotal iMMagine-1 Study of Anito-cel for Relapsed/Refractory Multiple Myeloma to be Presented Orally...Kite will also share new data on its next-generation bicistronic autologous CAR T-cell therapies, KITE-363 and KITE-753...A key presentation for Yescarta (axicabtagene ciloleucel) includes a joint analysis of 4-year follow-up data from ZUMA-7, which evaluated Yescarta as a second-line therapy in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) eligible for autologous stem-cell transplant (ASCT), alongside 2-year follow-up data from ALYCANTE that evaluated patients who were ASCT ineligible."

Clinical data • Acute Lymphocytic Leukemia • Burkitt Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Large B Cell Lymphoma • Mantle Cell Lymphoma • Multiple Myeloma

Arcellx Provides Third Quarter 2025 Financial Results (Businesswire) - "Collaboration revenue was $4.9 million and $26.0 million for the quarters ended September 30, 2025 and 2024, respectively....This decrease was primarily driven by completion of dosing and manufacturing of anito-cel in the iMMagine-1 trial in the fourth quarter of 2024....Research and development expenses were $35.1 million and $39.2 million for the quarters ended September 30, 2025 and 2024, respectively...This decrease was primarily driven by completion of dosing and manufacturing of anito-cel in the iMMagine-1 trial in the fourth quarter of 2024."

Commercial • Multiple Myeloma

Single-cell transcriptomics reveal mechanisms of efficacy and toxicity in anti-BCMA CAR-T cell therapies for multiple myeloma (ASH 2025) - "Understanding the biological basis for differences inefficacy and toxicity across anti-BCMA CAR T cell therapies is key to improving outcomes.MethodsWe performed a retrospective study of patients treated with cilta-cel (n=23), ide-cel (n=22), or anito-cel(n=14) at Massachusetts General Hospital with biobanked samples available. Additionally, limited effector CAR+ T cell expansionappears to drive poor cilta-cel outcomes, underscoring the importance of CAR T cell fitness andpersistence. These findings highlight a potential therapeutic window for optimizing cilta-cel outcomesthrough early monitoring and potential opportunities for clinical interventions."

CAR T-Cell Therapy • Clinical • IO biomarker • Hematological Malignancies • Multiple Myeloma • CD8

Population differences and comparative efficacy between ciltacabtagene autoleucel (cilta-cel) from the cartitude-1 study and anitocabtagene autoleucel (anito-cel) from the iMMagine-1 study in patients with relapsed / refractory multiple myeloma (RRMM) (ASH 2025) - P1/2, P3 | "Introduction: Cilta-cel is a BCMA-directed CAR T-cell therapy approved in the US, the EU, and othercountries for the treatment of adult patients (pts) with lenalidomide-refractory RRMM after at least 1prior line of therapy (pLOT), including a proteasome inhibitor and an immunomodulatory drug. There were significant differences in pt characteristics between CART-1 and iMM-1,particularly the number of pLOT. This MAIC approach allowed for an indirect treatment comparison,which demonstrated that pts who received cilta-cel were more likely to achieve deeper responsescompared to those treated with anito-cel. Due to the paucity of information, PFS and OS were not part ofthe analysis."

Clinical • Hematological Malignancies • Multiple Myeloma

Phase 2 registrational study of anitocabtagene autoleucel for the treatment of patients with relapsed and/or refractory multiple myeloma: Updated results from iMMagine--1 (ASH 2025) - P1, P2 | "Ongoing results from the Phase 2 iMMagine-1 trial demonstrate deep and durable efficacyand manageable safety in a heavily pre-treated, refractory 4L+ RRMM population. No delayed or non-ICANS neurotoxicities including no Parkinsonism, no cranial nerve palsies, no Guillain-Barré syndrome,and no IEC-associated enterocolitis have been observed across the Phase 1 or Phase 2 iMMagine-1studies to date. Updated data including safety and efficacy outcomes in all patients at a later data cut-offdate will be presented."

Clinical • IO biomarker • P2 data • Anemia • CNS Disorders • Gastrointestinal Disorder • Hematological Malignancies • Infectious Disease • Movement Disorders • Multiple Myeloma • Neutropenia • Parkinson's Disease • Thrombocytopenia

THE IMPACT OF CAR-T IN MULTIPLE MYELOMA (SIE 2025) - P3 | "In the absence of a randomized head-to-head comparison among ide-cel and cilta-cel, a retrospective, multicenter, analysis of 586 pts treated with either cilta-cel or ide-cel showed the superiority of Cilta-cel vs ide-cel in terms of response rates, PFS and OS, though associated with a more burdensome toxicity profile in terms of high-grade CRS, delayed neurotoxicity, and infections.7Anitocabtagene autoleucel (anito-cel, previously known as CART-ddBCMA) is an anti-BCMA CAR T-cell construct modeled to express a D-domain binder between the CD8 hinge-region and the transmembrane domain...Also, long-term safety data revealed a manageable profile, supporting BMS-986393 as a potential treatment for RRMM and further research (e.g., the ongoing phase II QUINTESSENTIAL study.10Interestingly, preliminary data from patients with 1-3 prior lines of therapy including a PI and an IMiD are also encouraging, with high rates of response that deepened over time and no new safety..."

Hematological Malignancies • Infectious Disease • Multiple Myeloma • CD8

Rare Glomerular Injury After Chimeric Antigen Receptor T Cell Therapy: Collapsing Glomerulopathy and Thrombotic Microangiopathy (KIDNEY WEEK 2025) - "Case Description A 65-year-old male with diabetes mellitus and multiple myeloma initially treated with lenalidomide, bortezomib, and dexamethasone, who achieved very good partial response followed by high dose melphalan and autologous stem cell transplant a year later. He continued maintenance lenalidomide until he was found to have recurrent disease by next-generation sequencing and started on daratumumab and carfilzomib. However, he had progression of disease, and decision was to proceed with CART-ddBCMA with Fludarabine and Cyclophosphamide lymphodepletion. Course complicated by CRS grade 1 (treated with tocilizumab and dexamethasone) and concern for IEC-associated hemophagocytic lymphohistiocytosis (IEC-HS) (treated with Anakinra and Siltuximab)...Our case suggests an additional mechanism of kidney injury through direct nephrotoxicity manifesting as collapsing glomerulopathy. Only one other case has been described in literature in which biopsy-proven collapsing..."

CAR T-Cell Therapy • IO biomarker • Acute Kidney Injury • Diabetes • Glomerulonephritis • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Hypotension • Immunology • Leukemia • Metabolic Disorders • Multiple Myeloma • Nephrology • Rare Diseases • Renal Disease

…Data from the iMMagine-1 (NCT05396885) presented at the 2025 International Myeloma Society Annual Meeting in Toronto, Canada (Pharmacy Times) - "The ORR was 97% (83/86), with a complete response or stringent complete response achieved in 62% (53/86). Among patients evaluable for MRD, (n = 58), 93.1% (54/58) reached MRD negativity at a sensitivity of at least 10⁻⁵, with a median time to MRD negativity of one month (range, 1–6). By Kaplan-Meier estimates, 12-month duration of response (DoR), progression-free survival (PFS), and overall survival (OS) rates were 75.6%, 78.5%, and 96.5%, respectively."

P2 data • Multiple Myeloma

Phase 2 Registrational Study of Anitocabtagene Autoleucel for Relapsed and/or Refractory Multiple Myeloma (RRMM): Updated Results from iMMagine-1 (IMS 2025) - P2 | "Ongoing results from iMMagine-1 demonstrate deep and durable efficacy and manageable safety in a 4L+ RRMM population. No delayed or non-ICANS neurotoxicities including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome have been observed across the Phase 1 or Phase 2 iMMagine-1 studies to date. Data including efficacy and safety in all treated pts will be presented."

IO biomarker • P2 data • CNS Disorders • Hematological Disorders • Hematological Malignancies • Movement Disorders • Multiple Myeloma • Parkinson's Disease

Anitocabtagene Autoleucel: Innovation in BCMA-Targeting Therapeutics (IMS 2025) - No abstract available

Multiple Myeloma Unpacked (ICML 2025) - P3 | "Several other phase II studies have explored the efficacy of triplet regimens incorporating Rd as a backbone, combined with agents such as elotuzumab [30], ixazomib [31], or carfilzomib [32] as well as quadruplet regimen including daratumumab and carfilzomib [33]...The landscape of induction treatment has evolved with the incorporation of the anti-CD38 monoclonal antibody daratumumab (D) into the triplet bortezomib-thalidomide-dexamethasone (VTd) and, more recently, bortezomib-lenalidomide-dexamethasone (VRd)...In transplant-ineligible patients, VRd [45], daratumumab-lenalidomide-dexamethasone (DRd) [46, 47] and daratumumab-bortezomib-melphalan-prednisone (DVMP) [48, 49] have been the standards of cares for years...The FDA approval of isatuximab-bortezomib-lenalidomide-dexamethasone (Isa-VRd), based on the results of the IMROZ study [38], which demonstrated the superiority of Isa-VRd over VRd in terms of MRD negativity and PFS, introduces a new SoC...Consequently,..."

IO biomarker • Hematological Malignancies • Multiple Myeloma • Oncology • Plasmacytoma • Smoldering Multiple Myeloma • B2M • CRBN • CTCs • XPO1

Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma (GEM-AnitoFIRST) (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: PETHEMA Foundation | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

Anitocabtagene autoleucel: Data update from P2 iMMagine-1 trial (NCT05396885) for 4L + r/r multiple myeloma in H2 2025 (Gilead) - Q2 2025 Results

P2 data • Hematological Malignancies • Multiple Myeloma • Oncology

A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Arcellx, Inc. | Initiation date: Jan 2025 ➔ Apr 2025

Trial initiation date • CNS Disorders • Immunology • Myasthenia Gravis • Oncology

Study of Anitocabtagene-autoleucel in Relapsed or Refractory Multiple Myeloma (iMMagine-1) (clinicaltrials.gov) - P2 | N=129 | Active, not recruiting | Sponsor: Kite, A Gilead Company | Recruiting ➔ Active, not recruiting | Trial completion date: May 2025 ➔ Dec 2026 | Trial primary completion date: May 2024 ➔ Dec 2026

Enrollment closed • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma (GEM-AnitoFIRST) (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: PETHEMA Foundation

New P2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

PHASE 2 REGISTRATIONAL STUDY OF ANITOCABTAGENE AUTOLEUCEL FOR RELAPSED AND/OR REFRACTORY MULTIPLE MYELOMA (RRMM): UPDATED RESULTS FROM IMMAGINE-1 (EHA 2025) - P2 | "Ongoing preliminary results from the Phase 2 iMMagine-1 trial demonstrate deep and durable efficacy and manageable safety in a high-risk 4L+ RRMM population. No delayed or non-ICANS neurotoxicities including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome have been observed across the Phase 1 or Phase 2 iMMagine-1 studies to date. Updated data including efficacy and safety in all treated pts will be presented."

IO biomarker • P2 data • Anemia • CNS Disorders • Hematological Disorders • Hematological Malignancies • Movement Disorders • Multiple Myeloma • Neutropenia • Oncology • Parkinson's Disease • Thrombocytopenia

Arcellx Announces Its Participation at TD Cowen’s 6th Annual Oncology Innovation Summit and Its Investor Event During EHA2025 (Businesswire) - "Arcellx...announced two upcoming investor events: (i) TD Cowen’s 6th Annual Oncology Innovation Summit: Tuesday, May 27, 2025 at 9:00 a.m. PT (Virtual); (ii) Management and Physician Presentation and Discussion of iMMagine-1 Pivotal Study Results During EHA2025: Friday, June 13, 2025 at 8:30 p.m. CEST (Virtual and In-Person, Milan, Italy)."

P2 data • Multiple Myeloma

Anitocabtagene autoleucel: Protection of compound patent in US and EU until 2038 (Gilead) - Annual Meeting Of Stockholders 2025

Patent • Oncology

Gilead and Kite Announce Presentation of…Updated Results in Multiple Myeloma…at 2025…EHA (Businesswire) - "At EHA, Kite and its partner Arcellx will present updated findings from the Phase 2 registrational iMMagine-1 study of anitocabtagene-autoleucel (anito-cel) in relapsed/refractory multiple myeloma during an oral presentation (Abstract #S201)."

P2 data • Multiple Myeloma

Arcellx Announces New Positive Data for Its iMMagine-1 Study in Patients with Relapsed and/or Refractory Multiple Myeloma (Businesswire) - P2 | N=110 | iMMagine-1 (NCT05396885) | Sponsor: Kite, A Gilead Company | "Overall response rate (ORR) was 97% (114/117) with a complete response/stringent complete response (CR/sCR) rate of 68% (79/117) and a very good partial response or higher (>VGPR) rate of 85% (100/117), per International Myeloma Working Group (IMWG) criteria as investigator-assessed. Of those evaluable for minimal residual disease (MRD) testing at the time of this data cut, 93.3% (70/75) achieved MRD negativity at a minimum of 10-5 sensitivity. Six-month progression-free survival (PFS) and overall survival (OS) rates were 91.9% and 96.6%, respectively, and 12-month PFS and OS rates were 78.8% and 95.2%, respectively. Median PFS and median OS have not been reached."

P2 data • Multiple Myeloma

Arcellx Provides First Quarter 2025 Financial Results and Business Highlights (Businesswire) - "...'We are on track to present updated data on all 117 patients dosed in iMMagine-1 at the European Hematology Association meeting on Saturday, June 14, 2025, in Milan. As we accelerate toward becoming a commercial organization with the planned launch of anito-cel in 2026, we added two Board members'....Minimal Residual Disease (MRD) negativity was added as a dual primary endpoint in addition to progression-free survival in the global Phase 3, randomized controlled iMMagine-3 clinical study. The iMMagine-3 study was initiated in the second half of 2024 at approximately 130 study sites across North America, Europe, and the rest of the world."

Clinical protocol • Launch • P2 data • Multiple Myeloma

Dr Bishop on the Rationale for Evaluating Anito-Cel in R/R Myeloma (OncLive) - P1 | N=40 | NCT04155749 | Sponsor: Kite | "...anito-cel was investigated in patients with relapsed/refractory multiple myeloma...the FDA guided the study, notably because the CAR T-cell therapy has a synthetic binder...At a median follow-up of 38.1 months, treatment-emergent adverse effects (TEAEs), the study’s primary objective, included no delayed or non–immune effector cell–neurotoxicity syndrome (ICANS) neurotoxicities occurred, including no observed cases of Parkinsonism, Guilliain-Barré syndrome, or cranial nerve palsies...Early efficacy findings from the study revealed that patients treated with anito-cel achieved an overall response rate of 100%, including 79% of patients achieving a complete response (CR) or stringent CR. Of note, 13% of patients achieved a very good partial response, with 8% demonstrating a partial response. Minimal residual disease negativity at a sensitivity threshold of 10–5 was achieved in 89% of evaluable patients."

P1 data • Multiple Myeloma

Overview of iMMagine-1 Trial: Phase 2 Registrational Study of Anitocabtagene Autoleucel for the Treatment of R/R MM (OncLive) - P2 | N=110 | iMMagine-1 (NCT05396885) | Sponsor: Kite, A Gilead Company | "The iMMagine-1 trial evaluates anitocabtagene autoleucel (anti-BCMA chimeric antigen receptor [CAR] T-cell therapy) in patients with R/R MM...High response rates were observed, even in penta-refractory patients, suggesting durable disease control in a population with limited treatment options; Depth of response correlated with improved progression-free survival, reinforcing the potential of BCMA-targeted CAR T therapy in later-line settings....Toxicities were consistent with prior CAR T therapies, including cytokine release syndrome and neurotoxicity, but were generally manageable; Further follow-up is needed to assess long-term safety and durability of responses."

P2 data • Multiple Myeloma

Anitocabtagene autoleucel: Data from P2 iMMagine-1 trial (NCT05396885) for 4L + R/R multiple myeloma in H2 2025 (Gilead) - Q4 2024 Results

P2 data • Hematological Malignancies • Multiple Myeloma • Oncology