KOL Pulse -- Trial Profile

iMMagine-1 Trial

Anitocabtagene autoleucel (anito-cel) BCMA CAR-T for relapsed/refractory multiple myeloma -- Arcellx / Kite (Gilead)

R/R Multiple Myeloma BCMA CAR-T ASH 2024 / ASH 2025 Investigational -- BLA Filed
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Top KOLs Discussing iMMagine-1

Vincent Rajkumar
Vincent Rajkumar
@VincentRK
3,752 impressions
BiotechTV
BiotechTV
@BiotechTVHQ
2,348 impressions
BiotechTV
BiotechTV
@BiotechTV
2,294 impressions
Bertrand Delsuc
Bertrand Delsuc
@BertrandBio
2,034 impressions
Raj Chakraborty
Raj Chakraborty
@rajshekharucms
1,830 impressions
Juan Esteban Velez, MD
Juan Esteban Velez, MD
@JuanesVelezMD
1,237 impressions

iMMagine-1 Key Slides & Visuals

Official trial slides and relevant visuals shared by KOLs at ASH 2024 / ASH 2025. Click any image to expand or view on X.

Juan Esteban Velez, MD
Juan Esteban Velez, MD @JuanesVelezMD
CAR-T for RRMM Overview
1,237 impressions · 22 likes · 2025-02-08
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[Slide 1] 4825 Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Patients with Relapsed and/or Refractory Multiple Myeloma (RRMM): Efficacy and Safety with 38.1-Month Median Follow-up Michael R. Bishop, MD1, Jacalyn Rosenblatt, MD2, Binod Dhakal, MD, MS³, Noopur Raje, MD4, Daniella Cook, BS⁵, Mahmoud Gaballa, MD6, Estelle Emmanuel-Alejandro, BA7, Danielle Nissen, BS8, Kamalika Banerjee, MA9, Rebecca J. Chan, MD, PhD9, Ana Kostic, MD Christopher R. Heery, MD9, Tim Welliver, MD. PhD9, David Avigan, MD2, Andrzej J. Jakubowiak, MD, PhD10, and Matthew Frigault, MD. MS7 1. David and Etta Jones Center for Cellular Therapy. University of Chicago, Chicago L USA 2. Beth israel Medical Center, Harvard Medical School Boston MA USA 3. Division of Hematology and Oncology Department of Medical College Milwauke, Wt, USA: 4. Harvard Medical School Boston, MA USA 5. chusetts General Hospital Cancer Center Boston MA, USA 6. The University of Texas MD Anderson Cancer Center Houston TX, USA 7. Massechusetts General Hospital Boston MA USA 8. Medical Coffege of Wisconsin, Milasure W. USA 9. Arceilx, 2% Redwood City CA USA 10. Section of Onoslogy Department of Medicine, University of Chicago, Chicago L USA Introduction Results RRMM is characterized by progressively worse outcomes with each line of Figure 3: Patient Disposition Figure 5: Median PFS for All Patients is 30.2 Months (95% CI: 16.6-NE] Safety therapy1, and novel therapies are needed to provide durable responses in later- Enrolled eukapheresed Median PFS for CR/sCR Patients is 34.3 Months (95% CI: 24.2-NE] delayed or non ICANS neurotoxicities have been observed at median follow up of 38. months line patients. - Median Follow-up of 18. Months Range 25-54) including no incidence of Parkinsonism, no cranial nerve palsies, and no syndrome While BCMA CAR T-cell therapies have demonstrated compelling clinical activity One Successful Manufacture Anito-cel patient had Grade event post study treatment cardiac arrest due on study trag overdose) in patients with RRMM, outcomes continue to be limited particularly in patients - 100 All secondary primary malignancies (SPMs) were required to be reported irrespective of relatedness or timing Discontinued + Censored with high-risk disease characteristics - No SPMs of cell origin occurred Lymphodeptetion Hematologic SPMs myelodysplastic syndrome MDS were reported in patients as unrelated AEs by the Anitocabtagene autoleucel (anito-cel previously CART-ddBCMA) is an **39 investigator, and occurred the setting of disease progression patients heavily pre- treated with agents Total Desed Hypoxia/Heart allure - 80 known be associated with MDS autologous D Domain BCMA-directed chimeric antigen receptor (CAR) T-cell therapy being studied in patients with RRMM. **30 Table Associated Alls CRS and ICANS per ASTCT Criteria (N=38) CAR The BCMA-binding Domain is small, synthetic 8 kDa protein comprised of AE's DLI 100 cells DL2: T cells Total DL1, 100 10" CAR+ cells DLZ 10" CAR+ cells Safety Efficacy e=32 60 (N=38) 73 amino acids that fold into stable triple alpha helix bundle resulting - evaluable dosed in several key attributes described in Figure 115, Dose Escalation - patients PFS (%) CRS Grt G/2 Gr3 Gr4 Grt Gr2 Gr3 Gr4 Any Or Dose Escalation - --38 Max grade, (%) Expansion Cohort, **25 15(47%) 0.(0%) 3 (50%) 2(33%) (17%) 00(95%) This report presents efficacy and safety results with a median follow-up of 38. onset I 2 days months from the human Phase study of anito-cel in patients with 4L+ dose at 115 million cells (range, 112 million cells) 40 Arabon' max) 9 days) 9 days) RRMM Table 1: Patient and Disease Characteristics ICANS Grt Gr2 Gr3 Gr4 Grt Orz Gr3 Gre Any Figure 1: D-Domain Attributes Non-Antibody-Derived Synthetic Protein Max grade, (%) 3 (9%) (6%) 13%) 0 (0%) 0.00%) 0(0%) 1 (17%) 0 (0%) (10%) DL Total Small Domain construct Characteristics CAR+ cells CAR+ cells 20 onset jmin max) days 6 days) 7 days facilities high transduction (6*32) (w*34) I max) 17 days efficiency CAR positivity and CAR Age, median max) 56 76) density surface" All Subjects With CR/sCR Toxicity 19 (30%) 1(17%) 20 (53%) 0 Tockpumab (84%) 5(53%) Rapid Demain folding tack of Gonder I I 20(63%) (33%) 22(58%) Stability disulfide bonds, and a Place 0 6 12 18 24 30 36 42 48 54 60 emables - I -Domain CAR - White 20(00%) 4,67%) 22(64%) Time from Infusion (Months) black African American 3 (P%) 1,000 4(17%) Table Grade AEs per CTCAE after infusion (N+38) - - Asian (7%) 0(0%) 10%) n(%) n(%) structure Domale CARS have Other (7%) 100 10% - 14 33,(86.8%) Hypertension (7.9%) Structure - - signating - ECOG PS* Bivalent VHh D-Domain potentially more multiple Anemia 21.(55.3%) Preumonia 3 (7.9%) - - Res I (-25 kDa) kDa) 6(100%) 26 (68%) Estimated PFS Rate Patients (N-28) CRACR Patients (n+30) 17 AST* increased 2(6.3%) Prior Lines Therapy median - - (3.7) (3.18) 5-month 2 (%) Cardies arrest 2 (5.3%) (3-14) Methods 12 8 (21.1%) Celluits 2 (5.3%) refractory 6(100%) 30(100%) 5 (83%) 18 Febrie Pente refractory neutropenia 6(15.0%) Hypokalemia 2(5.3%) First-in-human Phase 1, multi-center, dose escalation trial in 4L+ RRMM Prior ASCT 25(78%) 4,67%) 29(70%) È Hyponetremes 2 (5.3%) Eligibility Time since diagnosis median 65years PFS Hypophosphatomisma 2 (6.3%) At least 3 prior lines of therapy including a PL IMD. and anti-CD38 antibody; (mm max) I Pain extremity 2 (5.3%) bridging therapy 20-(63%) 6(100%) I or triple-refractory disease following treatment with a PI, IMID, and anti-CD38 Figure 6: Median os for All Patients is Not Reached I I Sepsis* 2(5.3%) antibody as part of the same or different regimens - no - I - Median Follow of Months (Range: 25-54) Urinary tract infection 2(5.3%) and - - Measurable disease per at least of the criteria: serum M-protein 0 g/dL. unine M protein >200 mg/24 hours: involved serum free light chain >100 mg/L Figure 4: Best Overall Response Rate and MRD Negativity Conclusions 100 + Censored with abnormal K/A ratio; >1 extramedullary lesion on imaging, including at 100% ORR Anito-cel utilizes novel, synthetic, compact and stable Domain binder that facilitates high least lesion that is 21 cm and able to be followed by imaging assessments; 38 total patients (79%) achieved CR&CR or BMPCs >30% 12% transduction efficiency, CAR positivity, and CAR density on the T-cell surface. . 89% evaluable* patients wore MRD negative . 80 ECOG PS of or and adequate organ function minimum of sensitivity With median follow-up of 38. months, anito-cel achieved rapid, high response rates with long- term durable remissions in a refractory. heavily pre- treated population of whom 68% had high- Primary Endpoints: Incidence of TEAEs DLTs: establish the RP2D . word origoing 38 (39%): patients risk features: Select Secondary Endpoints BOR and ORR by IMWG Consensus Criteria11 median follow-up of months (%) EVUPK 60 CR achieved in 79% of patients Select Exploratory Endpoints: MRD negativity, DOR, PFS. os 2CR 79% 92% 79% os Median PFS of 30.2 months in an patients and 34.3 months in patients with 2CR Toxicity grading was performed per NCI CTCAE v 5.0. except for CRS and Median os not reached CANS which were graded per ASTCT consensus criteria time best Data cut-off: October 3. 2024 response 40 Similar efficacy and durable remissions were observed across high-risk subgroups CRNCR The anito-cel safety profile is predictable and manageable Figure 2: Phase Dose Escalation Study Design All Median time MRD regalivity of 10(09-56) No delayed or non-ICANS neurotoxicities including no Parkinsonism no cranial nerve Median duration response (95% 20 palsies, and no Guillain Barre syndrome were observed across the Phase and Phase 2 Chemotherapy (MMagine- 1)" dinical trials. Anito-cel efficacy & safety compares favorably with available treatments for RRMM, including for Apheresis Day 4. Table 2: Kaplan Estimated PFS Rates in All Patients & High-Risk Subgroups 0 RRMM bearing high-risk features Anito-cel is being developed with Kite's global bell therapy leadership infusion 0 6 12 18 24 30 36 42 48 54 60 CAR-T Day 0 24 Magine-1 NCT05396885) in the photal Phase trial evaluating anito-cel in patients with RRMM and X prior Patients n Time from Infusion (Months) months LOT including inhibitor, an IMD, and an anti- CD38 entibody Screening, (524) Dose AS B Escalation * " 13 1 . Consent, cells 12-month $ 75.9 72.2 Magine-3 is global, Phase trial comparing anito-cet to standard of care therapy patients Enrollment Optional I with RRMM after 1-3 prior LOT, including an anti- CD38 antibody and an IMID 1 500 CARY I Safety Follow- Patients Estimated Rate Therapy 24-manth PFS % %(96%C) Acknowledgments Expansion Cohort enrolled DL1 years post- S-nonth 05 are (92.8. The patients and their families cell infusion 10-manth 50.3 60.2 06 The staff caregivers, research coordinators and investigators at each participating institution 6 (330.65.3) (295,727) American - Therapy - FOR 06 zux - IN Ferment - Common I - DOR, - ECOD CANS MO estimated median reached 8 - - I = Card I I black - I : - , I I I NO. National - ! - 1 - I 20% - - Pear 3 15.1 I 204 AIR I the Presented at the American Society of Hematology 2024 Annual Meeting --- [Slide 2] iMMagine-1: Overall Response Rate and MRD Negativity Efficacy Evaluable Patients (N=86) ORR=97% 15% At a median follow-up of 9.5 months, ORR was 97% and sCR/CR rate was 62% 20% 93.1% (n=54/58) of evaluable patients were MRD negative at minimum of 10-⁵ sensitivity ≥VGPR 81% Evaluable 62% sCR/CR Patients Months (min - max) 62% Median time to first response 83 1.0 (0.9 7.3) Median time to MRD negativity of ≤10-⁵ 54 1.0 (0.9 6.4) Efficacy Evaluable Patients (N=86) Best Response: sCR/CR VGPR PR --- [Slide 3] PFS Rate (%) os Rate (%) (95% CI) (95% CI) 93.3% 96.5% 6-Month (84.4%, 97.2%) (89.6%, 98.9%) 78.5% 96.5% 12-Month (63.5%, 87.9%) (89.6%, 98.9%)
Kite, a Gilead Company
iMMagine-1 EHA 2025 Data
846 impressions · 9 likes · 2025-06-14
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[Slide 1] Abstract M X in PHASE 2 REGISTRATIONAL STUDY OF ANITOCABTAGENE AUTOLEUCEL FOR This abstract is embargoed until Thursday, June 12, 2025, 08:00 CEST. RELAPSED AND/OR REFRACTORY MULTIPLE MYELOMA (RRMM): UPDATED Presentation during EHA2025: All Oral presentations will be presented between Thursday, June 12 and Sunday, June 15, 2025 and will RESULTS FROM IMMAGINE-1 be accessible for on-demand viewing from June 18 to August 15, 2025 on the Congress platform. Gurbakhash Kaur Author(s): Gurbakhash Kaur, Ciara L. Freeman, Binod Dhakal, Richard T. Maziarz, Natalie Callander, Adam S. Sperling. Carolina D. Schinke, Andrzej J. Jakubowiak, Noa Biran, Abstract: S201 Douglas W. Sborov, Cindy Varga, Larry D. Anderson, Jr., Abhinav Deol, Abraham S. Kanate, Mehmet H. Kocoglu, Title: PHASE 2 REGISTRATIONAL STUDY OF ANITOCABTAGENE AUTOLEUCEL FOR RELAPSED AND/OR REFRACTORY Melhem M. Solh, Kamalika Banerjee, Krishna Rana, MULTIPLE MYELOMA (RRMM): UPDATED RESULTS FROM IMMAGINE-1 Ana Kostic, Enrigue Granados, Carolyn C. Jackson, Christopher R. Heery, Tim Welliver, Krina K. Patel, Type: Oral Presentation Matthew J. Frigault (Abstract release date: 05/14/25) EHA Library. Kaur G. 06/14/2025; Session title: Treatment of relapsed and/or refractory multiple myeloma (RRMM) 4159278; S201
Ben Derman
Ben Derman @bdermanmd
ASH24 CAR-T Highlights
804 impressions · 10 likes · 2024-12-11
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[Slide 1] LL&M winter symposium from + Lymphoma Leukemia k Myeloma Congress BCMA CAR-T in 2025 Other risks Relative risk of death from MAS/IEC-HS ICAHT myeloma 1 LOT Infections Early (2-3 LOT) Delayed neurotoxicity VS Refractory VS exposed Cranial nerve palsy Functional high-risk GBS Parkinsonian-like Access to CAR-T syndrome Any BCMA CAR-T is better Behavioral changes than NO CAR-T Do all patients need CAR-T in 2ⁿᵈ relapse? - No But CAR-T should be discussed in all patients - Yes IEC-HS = immune effector cell associated hemophagocytic lymphohistiocytosis-like syndrome; MAS = macrophage activation-like syndrome; ICAHT = immune effector cell-associated hematotoxicity; GBS = Guillain-Barré syndrome. llmwintersymposium.com --- [Slide 2] LL&M winter symposium from * Lymphoma Leukemia & Myeloma Congress Anito-Cel: A Highly Active BCMA CAR-T Anitocabtagene autoleucel (anito-cel) has a novel ddBCMA CAR-T design 100% ORR 100 + Censored 8% High-expression = Cell dose 13% 80 mPFS: 30.2 months Novel D-domain 60 Tonic stimulation PFS (%) ddBMCA stability Anito-cel Phase - 2VGP 40 2CR 79% 92% 79% 20 All Subjects — With CR/sCR 0 All Patients 0 6 12 18 24 30 36 42 48 54 60 4188 (N=38) Time from Infusion (Months) 4188 4188 All Subjects 38 34 28 24 19 12 6 3 2 1 0 sCR/CR VGPR #PR With CR/sCR 30 28 26 23 19 12 6 3 2 1 0 CD3C CD3C CD3C scFv Bivalent camelid VHh D-Domain (~25 kDa) (~25 kDa) (~8 kDa) No cases of delayed neurotoxicity - 38 patients - mFU: 34 months Bishop M, et al. Presented at: ASH; Dec 9, 2024; San Diego, CA. 4825. Ilmwintersymposium.com --- [Slide 3] LL&M winter symposium - + Complete Compress Predictors of Achieving MRD Neg - - NOw - 13 1.00 sBCMA at pre-infusion Cmax Measuring CAR-T in the Clinical Setting B OF I I I 0.75 1.0 P-0.516 P-0.019 I I 3 5- 0.00 0.5 0.29 0.0 P<0001 0.00 0 1 0 10 30 30 40 so «BCMA preinfusion, logo pot 10°cella/L 4. 2 Steel 7 1- J 1 10 3 C Day part CAB-T Months 2 0- CD4+ Tasive at apheresis* CD4+ TEM at apheresis IFN-Y at pre-infusion n-116 n=17 1 9=117 n=17 Regative Positive Negative Positive 50 P-0.013 00- P-0.000606 P-0.02 60- Blood naive CLCD4 CARJ, 40- BLOOD EM EMPLCD4 CAR-1, Lop. Serum into interferon gamma, npt 2 40 How to avoid "unfit" T-cells? Earlier CAR-T 20- X 20- 1. Treatments (eg alkylators?) T-cell deterioration 0- - - n-109 n-16 0. n=109 n-16 n=199 n-16 Rescue T-cells (CelMod?) Regative Positive Regative Positive Regative Positive Popat R, et al. Presented at: ASH; Dec 9, 2024; San Diego, CA. 1032. Mejia Saldarriaga, et al. Blood Adv. 2024;8(15): 3859-3869. Imwintersymposiun.com --- [Slide 4] LL&M winter symposium from * Lymphoma Leukemia & Myeloma Congress IMMagine-1 Anito-Cel - Efficacy ORR=97% Efficacy population: 86 patients 15% Median follow-up: 9.5 months Highly active: 20% ORR 97% Evaluable Patients Months (min max) sCR/CR 62% Median time to first response 83 1.0 (0.9 7.3) Fast acting: Median time to MRD negativity of ≤10⁻⁵ 54 1.0 (0.9 6.4) ≥VGPR Median time to 81% PFS Rate (%) 62% sCR/CR response 1 os Rate (%) (95% CI) (95% CI) 62% month 93.3% 96.5% 6-Month (84.4%, 97.2%) (89.6%, 98.9%) Deep responses: 78.5% 96.5% 12-Month Efficacy Evaluable Patients 93.1% MRD neg (63.5%, 87.9%) (89.6%, 98.9%) (N=86) 54/58 patients Best Response: sCR/CR VGPR PR Freeman C, et al. Presented at: ASH; Dec 9, 2024; San Diego, CA. 1031. Ilmwintersymposium.com
Rahul Banerjee, MD, FACP
Rahul Banerjee, MD, FACP @RahulBanerjeeMD
EHA 2025 iMMagine-1 Update
674 impressions · 9 likes · 2025-05-23
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[Slide 1] iMMagine-1: Immune-effector Cell-associated Neurotoxicity Syndrome (ICANS) ICANS Maximum ICANS Grade (N=117) N=117 Per ASTCT criteria 108 Median onset (min-max) 7 days (2-10ᵃ days) (92%) Median duration (min-maxᵇ) 4 days (1-12b days) Supportive Measures Tocilizumab 3% (3/117) 4 4 1 (3%) (3%) 0 0 (1%) Dexamethasone 5% (6/117) (0%) (0%) No ICANS Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 Anakinra 1% (1/117) Siltuximab 1% (1/117) 8% (9/117) of patients had ICANS of any grade; all cases resolved No delayed or non-ICANS neurotoxicities were observed, including no With the exception of n=1 Grade 1 ICANS (confusion) on day 31 post infusion that rapidly resolved incidence of Parkinsonism, no cranial nerve palsies, and no Guillain- b With the exception of n=1 max Grade 2 ICANS with 29-day duration to resolution Barré syndrome (n=117; median follow-up of 12.6 months, range: 5-29 months) Similarly, no delayed or non-ICANS neurotoxicities have been observed in the Phase 1 study (n=38; median follow-up of 38.1 months, range: 25-56 months) 1 Bishop MR, et al Blood (2024) 144 (Supplement 1) 4825 as presented in poster #4825 at ASH 2024 ASTCT American Society for Transplantation and Cellular Therapy --- [Slide 2] iMMagine-1: Cytokine Release Syndrome Maximum CRS Grade (N=117) Cytokine Release Syndrome (CRS) N=117 Per ASTCT criteria 82 Median onset (min-max) 4 days (1-17 days) (70%) Median duration (min-max) 2 days (1-9 days) Supportive Measures Tocilizumab 77% (90/117) 17 17 (15%) (15%) Dexamethasone 73% (85/117) 0 0 1 Anakinra 11% (13/117) (0%) (0%) (1%) Siltuximab 3% (4/117) No CRS Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 Vasopressor used 1% (1/117) Intubation/mechanical ventilation 1% (1/117) 85% (99/117) of patients had CRS Grade 1 or less, including 15% (17/117) with no CRS; the median onset was 4 days CRS management per protocol was in line with standard medical practice with no prophylactic administration of tocilizumab or dexamethasone % of patients with either no CRS or CRS that resolved by: For CRS onset in the first 48 hours, tocilizumab and dexamethasone were <7 days of anito-cel infusion: 80% (94/117) protocol recommended <10 days of anito-cel infusion: 97% (114/117) For CRS onset after the first 48 hours, if tocilizumab was administered at investigator discretion, dexamethasone was also recommended 71% (83/117) of patients either received no dexamethasone or a single 10 Grade 5 CRS occurred in a 76-year-old patient who had rapidly progressive mg dose of dexamethasone for CRS management disease between screening and baseline and did not respond to bridging therapy ASTCT Amencan Society for Transplantation and Cellular Therapy --- [Slide 3] iMMagine-1: PFS and OS Rates Estimated by Kaplan-Meier N=117 PFS Rate (%) os Rate (%) (95% CI) (95% CI) 91.9% 96.6% 6-Month (85.0%, 95.7%) (91.1%, 98.7%) 79.3% 95.2% 12-Month (68.6%, 86.7%) (88.7%, 98.0%) Median follow-up of 12 6 months (range 5 to 29 months) PFS, progression free survival; OS, overall survival --- [Slide 4] iMMagine-1: Treatment-Emergent Adverse Events (Non-CRS/Non-ICANS): Any Grade AEs ≥20% Grade 3/4 AEs after cell infusion after cell infusion (N=117) (N=117) The most common Grade 3 and higher treatment- emergent AEs (TEAEs) were cytopenias Hematologic Neutropenia 79 (68%) 77 (66%) Anemia 32 (27%) 28 (24%) No cases of immune effector cell-associated Thrombocytopenia 28 (24%) 28 (24%) enterocolitis have been reported Non-hematologic No replication competent lentivirus detected Fatigue 42 (36%) 3 (3%) Hypogammaglobulinemia 40 (34%) 1 (1%) Headache 35 (30%) 2 (2%) No secondary primary malignancies of T-cell origin or Hypophosphatemia 34 (29%) 2 (2%) hematologic malignancies were reported Nausea 32 (27%) 1 (1%) Diarrhea 32 (27%) 1 (1%) Three deaths occurred due to TEAEs (related and Hypertension 23 (20%) 12 (10%) unrelated to anito-cel) Hypokalemia 23 (20%) 2 (2%) - Retroperitoneal hemorrhage* secondary to biopsy complication Infections 61 (52%) 11 (9%) - Cytokine Release Syndrome Upper respiratory tract infection 15 (13%) 2 (2%) Urinary tract infection 8 (7%) 2 (2%) - Fungal infection COVID-19 7 (6%) 1 (1%) "At baseline prior to infusion the patient developed plasma cell leukemia, which was an exclusion critena. Evidence of Grade 4 hemophagocytic lymphohistiocytosis at time of death (only case to date) TEAE IS defined as, 1) any AE with onset date on or after the first anito-cel infusion until 90 days after the first anito-cel infusion regardless of causality assessment or until start of subsequent ti-myeloma therapy whichever is earlier or 2) any AE occurring at any time assessed by the investigator as related to anito- cel
Daniel Auclair
Daniel Auclair @AuclairDan
EHA 2025 Anito-cel D-Domain Safety
545 impressions · 5 likes · 2025-06-14
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[Slide 1] Kite A ARCELLX A GILEAD Company

iMMagine-1 Top Tweets

Top 10 by impressions -- click to view on X

Vincent Rajkumar
Vincent Rajkumar@VincentRK

#2 Anitocabtagene Autoleucel for Relapsed Refractory Myeloma: IMMagine-1 Trial results. #ASH24 @freemanlciaraMD @bhemato @GKaurMD @DrKrinaPatel #ASH24 New CAR-T for myeloma. Registration study. Impressive results.

👁 3,752 ♡ 39 ↻ 7 2024-11-28
BiotechTV
BiotechTV@BiotechTVHQ

#ASH24: @arcellx CEO Rami Elghandour discusses a data update of the iMMagine-1 Study for the company's BCMA CAR-T. The data showed a 62% CR/sCR at a median follow-up of 9.5 months. #ASH24 $ACLX

👁 2,348 ♡ 10 ↻ 4 2024-12-09
BiotechTV
BiotechTV@BiotechTV

#EHA2025: @arcellx CEO Rami Elghandour discusses the results presented today of the iMMagine-1 Study for the company's BCMA CAR-T. #EHA2025 $ACLX

👁 2,294 ♡ 7 ↻ 3 2025-06-14
Bertrand Delsuc
Bertrand Delsuc@BertrandBio

Arcellx $ACLX $GILD Announces New Positive Data for Its iMMagine-1 Study in Patients With RRMM to be Presented During an Oral Presentation at #ASH24 #BCMA #CART (--> $JNJ $LEGN) Phase 2 iMMagine-1 DCO 31-10-2024 - mFU 9.5mo - n=86 evaluable for efficacy

👁 2,034 ♡ 9 ↻ 0 2024-12-09
Raj Chakraborty
Raj Chakraborty@rajshekharucms

Anito-cel: Updated data from IMMagine-1 trial (n=58; ~10 months median f/u) ORR/>=CR: 95%/62% (comparable to cilta-cel). No delayed neurotoxicity, CN palsies, GBS, or Parkinsonian-like symptoms till date

👁 1,278 ♡ 12 ↻ 2 2024-11-24
Juan Esteban Velez, MD
Juan Esteban Velez, MD@JuanesVelezMD

Cart for RRMM, by @mmejia91 Need to search for prognostic factors as lymphocytosis >1.0 x 103/uL Must discuss for all patients in 2nd line (> OS in cartitude 4) New Cart coming as Anitocel and GPRC5D targets being explored #LLMWinter2025

👁 1,237 ♡ 22 ↻ 7 2025-02-08
Kite, a Gilead Company
Kite, a Gilead Company@KitePharma

We're excited to share that our partner @Arcellx presented new data from the pivotal Phase 2 iMMagine-1 study in relapsed/refractory multiple myeloma at #EHA2025 today.

👁 846 ♡ 9 ↻ 2 2025-06-14
Ben Derman
Ben Derman@bdermanmd

Didn't have time to post everything from #ASH24, but some additional highlights on the CAR T side of things. 1) Anito-cel: Poster 4825: Median PFS of 30 months from the phase 1, with high-risk disease performing at least as good as all-comers

👁 804 ♡ 10 ↻ 3 2024-12-11
Rahul Banerjee, MD, FACP
Rahul Banerjee, MD, FACP@RahulBanerjeeMD

9/ #EHA2025 #MMsm CAR-T: Not #ASCO25 per se but of course must add: S201 iMMagine-1 (@GKaurMD): Per press release, now n=117 anito-cel recipients (3+ prior LOT). MRD neg 70/117, 12-mo PFS 79%. I hope this gets approved ASAP!

👁 674 ♡ 9 ↻ 2 2025-05-23
Raj Chakraborty
Raj Chakraborty@rajshekharucms

2. iMMagine-1 Phase 2 trial of Anito-cel (@DrKrinaPatel): >=3 prior LoT, 86% triple-class refractory, 40% penta-refractory, ~40% with high-risk cytogenetics. >=CR rate~70% (79/117 patients) MRD-neg rate (10^-5) among evaluable patients (n=75): 93%

👁 552 ♡ 10 ↻ 2 2025-11-28

About the iMMagine-1 Trial

iMMagine-1 (NCT05469893) is a Phase 2 registrational study evaluating anitocabtagene autoleucel (anito-cel), an autologous BCMA-directed CAR-T cell therapy developed by Arcellx and Kite (a Gilead company), in patients with relapsed and/or refractory multiple myeloma who have received three or more prior lines of therapy. Anito-cel uses a novel, compact synthetic D-Domain binder (~8 kDa) instead of a traditional scFv, which may reduce tonic signaling and contribute to its differentiated safety profile. In the pivotal cohort of 117 triple-class exposed patients, anito-cel demonstrated an overall response rate (ORR) of 96% with a complete response/stringent complete response (CR/sCR) rate of 74%. MRD negativity rates were 95% at 10^-5 sensitivity and 78% at 10^-6. The safety profile was notable for low-grade CRS (83% Grade 0-1), very low ICANS (8%), and zero delayed neurotoxicities including no Parkinsonism or cranial nerve palsies. Anito-cel is investigational; a BLA has been filed with an anticipated PDUFA date of December 23, 2026. In February 2026, Gilead acquired Arcellx for up to $7.8 billion.

iMMagine-1 in the News

Trial Methodology & Results

Study Design

Phase 2, single-arm, registrational/pivotal study of anitocabtagene autoleucel (anito-cel), an autologous BCMA-directed CAR-T cell therapy using a novel synthetic D-Domain binder. Manufacturing turnaround of 17 days or less with 96%+ in-spec rate.

Population

117 patients with relapsed and/or refractory multiple myeloma, triple-class exposed (3+ prior lines of therapy). Approximately 40% penta-refractory, ~40% with high-risk cytogenetics.

Interventions

Anitocabtagene autoleucel (anito-cel), a BCMA-directed CAR-T cell therapy with a compact 8 kDa D-Domain binder that reduces tonic signaling. Single infusion following lymphodepletion.

Primary Endpoints

Overall response rate (ORR). Key secondary endpoints include CR/sCR rate, MRD negativity, duration of response, PFS, and OS.

Response & MRD Negativity

In 117 evaluable patients at a median follow-up of 15.9 months, anito-cel achieved an ORR of 96% (112/117) with a CR/sCR rate of 74% (86/117). MRD negativity was achieved in 95% of evaluable patients at 10^-5 sensitivity and 78% at 10^-6. Sustained MRD negativity (6+ months) was observed in 83% of MRD-evaluable patients. Median time to MRD negativity was approximately 1 month.

96% ORR, 74% CR/sCR, 95% MRD-neg

Source: Blood (ASH) →

Progression-Free Survival (PFS)

PFS rates at key timepoints: 82.1% at 12 months, 67.4% at 18 months, and 61.7% at 24 months. Phase 1 data demonstrated a median PFS of 30 months, with high-risk disease performing at least as well as all-comers. These durability signals are particularly notable in a triple-class exposed, heavily pretreated population.

24-month PFS: 61.7%

Source: Gilead/Kite Press Release →

Overall Survival (OS)

OS rates were 94% at 12 months, 88% at 18 months, and 83% at 24 months. These survival outcomes compare favorably in the context of heavily pretreated R/R multiple myeloma, though cross-trial comparisons should be interpreted with caution given the single-arm design.


Source: Gilead/Kite Press Release →

Safety & Tolerability

The safety profile of anito-cel was differentiated by remarkably low-grade toxicity. CRS occurred in 86% of patients but was overwhelmingly Grade 0-1 (83% of all patients). Only 8% experienced ICANS of any grade, with 92% having no ICANS events. Critically, there were zero delayed neurotoxicities -- no movement and neurocognitive treatment-emergent adverse events (MNTs), no Parkinsonism, no cranial nerve palsies, and no Guillain-Barre syndrome. One Grade 5 CRS event was reported.

Zero delayed neurotoxicities

Source: Blood (ASH) →

Clinical Implications

Anito-cel demonstrates competitive efficacy versus approved BCMA CAR-T therapies ciltacabtagene autoleucel (Carvykti) and idecabtagene vicleucel (Abecma), with a potentially differentiated safety profile characterized by the absence of delayed neurotoxicities. The 96% ORR, 95% MRD negativity rate, and 24-month PFS of 61.7% position anito-cel as a potential best-in-class BCMA CAR-T candidate. However, as this is a single-arm study, cross-trial comparisons are unreliable and randomized data against established CAR-T options would be needed to confirm superiority. Anito-cel remains investigational (BLA filed, PDUFA Dec 2026).

Key KOL Sentiments -- iMMagine-1

DoctorSentimentComment
Christopher Heery MD ● POSITIVE Congrats on a great presentation @GKaurMD https://t.co/gBgjGv64CZ
Daniel Auclair ● POSITIVE @GKaurMD presenting anito-cel IMMagine-1 at #EHA2025 . The innovative synthetic antigen binder D-domain in anito-cel resulted in an impressive safety profile (almost no CRS) with good activity #mmsm https://t.co/8flzKTnzJW
Kite, a Gilead Company ● POSITIVE We're excited to share that our partner @Arcellx presented new data from the pivotal Phase 2 iMMagine-1 study in relapsed/refractory multiple myeloma at #EHA2025 today. https://t.co/ZIdewOf1Fj
Arcellx ● POSITIVE Yesterday evening, we announced new positive data from our Phase 2 pivotal iMMagine-1 study of anitocabtagene autoleucel (anito-cel), in patients with relapsed or refractory multiple myeloma, demonstrating anito-cel's potential to be a best-in-class treatment option.
Yelak Biru ● POSITIVE Congratulations Dr. Kaur on this iMMagine-1 study result and presetatnion at #EHA2025 #EHA25 #mmsm @GKaurMD
Arcellx ● POSITIVE Attending #EHA2025? Learn the latest on our iMMagine-1 study of anitocabtagene autoleucel (anito-cel) in patients with #RRMM. We are excited to meet with #hematology physicians at the @EHA_Hematology Congress. #MedX #MedEd https://t.co/eTc8tYYcfp
BiotechTV ● NEUTRAL EHA 2025: @arcellx CEO Rami Elghandour discusses the results presented today of the iMMagine-1 Study for the company's BCMA CAR-T. #EHA2025 $ACLX
Daniel Auclair ● NEUTRAL @GKaurMD updating anito-cel IMMagine-1 study at #EHA2025. The innovative synthetic ligand-binding D-domain resulted in a robust safety profile with few AEs (including almost no CRS) and good activity #mmsm https://t.co/o2nNlNnegQ
BiotechTV ● NEUTRAL ASH 2024: @arcellx CEO Rami Elghandour discusses a data update of the iMMagine-1 Study for the company's BCMA CAR-T. The data showed a 62% CR/sCR at a median follow-up of 9.5 months. #ASH24 $ACLX
Bertrand Delsuc ● NEUTRAL Arcellx $ACLX $GILD Announces New Positive Data for Its iMMagine-1 Study in Patients With RRMM to be Presented During an Oral Presentation at #ASH24 #BCMA #CART (--> $JNJ $LEGN)
Moffitt Cancer Center ● NEUTRAL Join Ciara Freeman, PhD (@freemanlciaraMD) as she presents the preliminary results from the IMMagine-1 trial, a study of anticabtagene autoleucel for patients with relapsed and/or refractory multiple myeloma.
Juan Esteban Velez, MD ● NEUTRAL Cart for RRMM, by @mmejia91 Need to search for prognostic factors as lymphocytosis >1.0 x 103/uL Must discuss for all patients in 2nd line (> OS in cartitude 4) New Cart coming as Anitocel and GPRC5D targets being explored #LLMWinter2025
Samer Al Hadidi, MD,MS,FACP ● NEUTRAL #ASH24 #mmsm @ASH_hematology Oral myeloma: Anito cel , iMMagine-1 trial ORR 97%, CR or better of 62% PFS and OS data provided there were older pts overall
Rahul Banerjee, MD, FACP ● NEUTRAL #ASH25 @DrKrinaPatel iMMagine anito-cel data. if I'm doing my math right, this must be n > 150 with 10 months follow-up across both studies. no delayed neurotox or IEC-HS. I think this signal is real!!
Samer Al Hadidi, MD,MS,FACP ● NEUTRAL #ASH25 #mmsm @ASH_hematology Oral myeloma- iMMagine-1 /Anito-cel @DrKrinaPatel 15.9mo follow-up 96% ORR 74% sCR/CR 95% MRD-negative 83% sustained MRD negativity 6mo. 24mo PFS 62%, OS 83%. NO delayed neurotoxicity, Parkinsonism
Vincent Rajkumar ● NEUTRAL #2 Anitocabtagene Autoleucel for Relapsed Refractory Myeloma: IMMagine-1 Trial results. #ASH24 @freemanlciaraMD @bhemato @GKaurMD @DrKrinaPatel #ASH24 New CAR-T for myeloma. Registration study. Impressive results.
Rahul Banerjee, MD, FACP ● NEUTRAL 9/ #EHA2025 #MMsm CAR-T: Not #ASCO25 per se but of course must add: S201 iMMagine-1 (@GKaurMD): Per press release, now n=117 anito-cel recipients (3+ prior LOT). MRD neg 70/117, 12-mo PFS 79%. I hope this gets approved ASAP!
Samer Al Hadidi, MD,MS,FACP ● NEUTRAL #ASH24 #mmsm @ASH_hematology Oral myeloma: Anito cel , iMMagine-1 trial No delayed NT and no cranial palsy and no 2ry heme malignancies (short follow up) CRS split, there are pts with no CRS and G2 in 13% Data on ICANS 3 deaths reported
Samer Al Hadidi, MD,MS,FACP ● NEUTRAL #ASH24 #mmsm @ASH_hematology Oral myeloma: Anito cel , iMMagine-1 trial Anito cel Phase I data summarized and study schema
Myeloma Patients Europe ● NEUTRAL Gurbakhash Kaur presents the results of the phase 2 iMMagine-1 trial investigating anito-cel, a new BCMA #CART therapy: 97% of patients responded to the treatment and 93% achieved #MRD negativity #EHA2025
Moffitt Cancer Center ● NEUTRAL LIVE from #ASH24, in a packed out session Ciara Freeman, MD (@freemanlciaraMD) presents early trial results that show high success rates and manageable side effects for advanced multiple myeloma.
Ben Derman ● NEUTRAL Didn't have time to post everything from #ASH24, but some additional highlights on the CAR T side of things. 1) Anito-cel: Poster 4825: Median PFS of 30 months from the phase 1
San Francisco Biotechnology Network ● NEUTRAL #EHA25: Gilead, Arcellx continue to tout safety of multiple myeloma cell therapy anito-cel https://t.co/JwN9L5TFfe #biotech #news
Raj Chakraborty ● NEUTRAL Anito-cel: Updated data from IMMagine-1 trial (n=58; ~10 months median f/u) ORR/>=CR: 95%/62% (comparable to cilta-cel). No delayed neurotoxicity, CN palsies, GBS, or Parkinsonian-like symptoms till date
Raj Chakraborty ● NEUTRAL 2. iMMagine-1 Phase 2 trial of Anito-cel (@DrKrinaPatel): >=3 prior LoT, 86% triple-class refractory, 40% penta-refractory, ~40% with high-risk cytogenetics. >=CR rate~70% (79/117 patients) MRD-neg rate (10^-5) among evaluable patients (n=75): 93%