Arcellx Announces New Positive Data for Its iMMagine-1 Study in Patients With Relapsed or Refractory Multiple Myeloma to be Presented During an Oral Presentation at the 66th ASH Annual Meeting and Exposition
Arcellx (NASDAQ: ACLX) announced new positive data from its Phase 2 pivotal iMMagine-1 study of anitocabtagene autoleucel (anito-cel) in patients with relapsed or refractory multiple myeloma. The study showed a 97% overall response rate and 62% complete response rate at a median follow-up of 9.5 months.
Key highlights include 93.1% minimal residual disease negativity among evaluable patients, and no delayed neurotoxicities observed in over 150 patients across Phase 1 and iMMagine-1 studies. The Phase 1 study demonstrated a 30.2-month median progression-free survival with median overall survival not reached. The safety profile showed 86% of patients had Grade ≤1 cytokine release syndrome, with 17% experiencing no CRS.
Arcellx (NASDAQ: ACLX) ha annunciato nuovi dati positivi dal suo studio pivotale di Fase 2 iMMagine-1 riguardante l'anitocabtagene autoleucel (anito-cel) in pazienti con mieloma multiplo recidivante o refrattario. Lo studio ha mostrato un tasso complessivo di risposta del 97% e un tasso di risposta completa del 62% con un follow-up medio di 9,5 mesi.
I punti salienti includono il 93,1% di negatività per malattia residua minima tra i pazienti valutabili, e nessuna neurotossicità ritardata osservata in oltre 150 pazienti nei studi di Fase 1 e iMMagine-1. Lo studio di Fase 1 ha dimostrato una sopravvivenza libera da progressione mediana di 30,2 mesi, con una sopravvivenza complessiva mediana non raggiunta. Il profilo di sicurezza ha mostrato che l'86% dei pazienti aveva sindrome da rilascio di citochine di grado ≤1, con il 17% che non ha manifestato CRS.
Arcellx (NASDAQ: ACLX) anunció nuevos datos positivos de su estudio pivotal de Fase 2 iMMagine-1 sobre anitocabtagene autoleucel (anito-cel) en pacientes con mieloma múltiple que ha recaído o es refractario. El estudio mostró una tasa general de respuesta del 97% y una tasa de respuesta completa del 62% con un seguimiento medio de 9,5 meses.
Los aspectos clave incluyen 93,1% de negatividad para enfermedad residual mínima entre los pacientes evaluables, y no se observaron neurotoxicidades retardadas en más de 150 pacientes en los estudios de Fase 1 e iMMagine-1. El estudio de Fase 1 demostró una supervivencia libre de progresión mediana de 30,2 meses, con una supervivencia general mediana no alcanzada. El perfil de seguridad mostró que el 86% de los pacientes tenía síndrome de liberación de citoquinas de grado ≤1, y el 17% no experimentó CRS.
Arcellx (NASDAQ: ACLX)는 재발성 또는 불응성 다발골수종 환자를 위한 anitocabtagene autoleucel (anito-cel)의 2상 주요 iMMagine-1 연구에서 긍정적인 새로운 데이터를 발표했습니다. 이 연구는 97%의 전체 반응률과 62%의 완전 반응률을 보였으며, 중앙 추적 관찰 기간은 9.5개월이었습니다.
주요 내용으로는 평가 가능한 환자 중 93.1%의 최소 잔여 질병 음성을 포함하며, 1상 및 iMMagine-1 연구에서 150명 이상의 환자에서 지연 신경독성이 관찰되지 않았습니다. 1상 연구는 30.2개월의 중앙 무병 생존 기간을 보여주었으며, 중앙 전체 생존 기간은 도달하지 못했습니다. 안전성 프로필은 86%의 환자가 등급 ≤1의 사이토카인 방출 증후군을 가졌고, 17%는 CRS를 경험하지 않았습니다.
Arcellx (NASDAQ: ACLX) a annoncé de nouvelles données positives issues de son étude pivotale de Phase 2 iMMagine-1 sur l'anitocabtagene autoleucel (anito-cel) chez des patients atteints de myélome multiple récidivant ou réfractaire. L'étude a montré un taux de réponse global de 97% et un taux de réponse complète de 62% avec un suivi médian de 9,5 mois.
Les points clés incluent 93,1% de négativité pour la maladie résiduelle minimale parmi les patients évaluables, et aucune neurotoxicité retardée observée chez plus de 150 patients dans les études de Phase 1 et iMMagine-1. L'étude de Phase 1 a montré une survie sans progression médiane de 30,2 mois, avec une survie globale médiane non atteinte. Le profil de sécurité a montré que 86% des patients avaient un syndrome de libération de cytokines de grade ≤1, avec 17% ne présentant pas de CRS.
Arcellx (NASDAQ: ACLX) hat neue positive Daten aus seiner wegweisenden Phase-2-Studie iMMagine-1 zu anitocabtagene autoleucel (anito-cel) bei Patienten mit rezidivierendem oder refraktärem multiplem Myelom bekannt gegeben. Die Studie zeigte eine Gesamtansprechrate von 97% und eine komplette Ansprechrate von 62% bei einer medianen Nachbeobachtungszeit von 9,5 Monaten.
Wichtige Punkte sind 93,1% Negativität für minimale Restkrankheit unter evaluierbaren Patienten, und es wurden keine verzögerten neurotoxischen Effekte bei über 150 Patienten in den Phase-1- und iMMagine-1-Studien beobachtet. Die Phase-1-Studie wies eine mediane progressionsfreie Überlebenszeit von 30,2 Monaten auf, wobei die mediane Gesamtüberlebenszeit nicht erreicht wurde. Das Sicherheitsprofil zeigte, dass 86% der Patienten eine Zytokinentzugsreaktion Grad ≤1 hatten, wobei 17% keine CRS erlebten.
- 97% overall response rate (ORR) in Phase 2 trial
- 62% complete response/stringent complete response rate
- 93.1% achieved minimal residual disease negativity
- 30.2-month median progression-free survival in Phase 1 study
- Strong safety profile with 86% of patients having Grade ≤1 or no cytokine release syndrome
- 8% of patients were treated as outpatients, indicating potential cost savings
- Three deaths occurred due to treatment-emergent adverse events
- 54% of patients experienced Grade ≥3 neutropenia
- 20% experienced Grade ≥3 thrombocytopenia
- 22% experienced Grade ≥3 anemia
Insights
The Phase 2 iMMagine-1 trial results for anito-cel are remarkably strong, showing a
The safety profile stands out with no delayed neurotoxicities observed in over 150 patients - a significant differentiator from other CAR-T therapies. The
The 30.2-month median progression-free survival from the Phase 1 study and strong durability signals in Phase 2 position anito-cel competitively in the RRMM treatment landscape. The
This pivotal trial data significantly derisks Arcellx's lead asset and strengthens its market position. The partnership with Kite/Gilead provides strong commercialization capabilities once approved. With a market cap of
The differentiated safety profile could drive market share gains versus competitors like J&J's Carvykti and BMS's Abecma. The potential for increased outpatient administration would provide economic advantages for treatment centers and improve accessibility. The progression into earlier treatment lines through the iMMagine-3 study could significantly expand the addressable market.
The robust efficacy data and clean safety profile position anito-cel favorably for FDA approval, with potential launch in 2025. This represents a major value inflection point for Arcellx shareholders.
-- Preliminary results from 86 patients enrolled in the Phase 2 pivotal iMMagine-1 study of anito-cel demonstrated
-- No delayed neurotoxicities have been observed to date with anito-cel, including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome in more than 150 patients dosed across the Phase 1 and iMMagine-1 studies --
-- 30.2-month median progression-free survival with a median follow-up of 38.1 months in the Phase 1 study of anito-cel; median overall survival not reached --
-- Company highlights additional presentations during the ASH Annual Meeting --
-- Company to host a live webcast event with an expert panel of clinicians on Monday, December 9, 2024 at 8 p.m. PT --
The Phase 2 iMMagine-1 data are from an October 31, 2024 data cutoff date, with a median follow-up of 9.5 months for the efficacy evaluable population. At the time of the data cut, 86 patients were evaluable for efficacy based on a follow-up of at least two months after treatment with anito-cel, and 98 patients were evaluable for safety based on a follow-up of at least one month after treatment with anito-cel. All patients received a single infusion of anito-cel (target dose of 115×106 CAR+ viable T cells). In the safety evaluable population, 85 of 98 patients (
Overall response rate (ORR) was
No delayed or non-ICANS neurotoxicities, including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome, have been observed to date in more than 150 patients dosed with anito-cel. Of the safety evaluable population,
Conclusions
Preliminary results from the Phase 2 iMMagine-1 study demonstrate deep and durable responses with a predictable and manageable safety profile in a high-risk fourth-line or higher (4L+) RRMM population, including triple- and penta-class refractory disease. Notably, no delayed or non-ICANS neurotoxicities, including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome, have been observed with anito-cel to date.
Ciara Freeman, M.D., Ph.D., Assistant Member, Department of Blood and Marrow Transplant and Cellular Immunotherapy, Moffitt Cancer Center said, “The data from the iMMagine-1 study demonstrate that this is a highly active product with impressive depth of responses achieved in patients with relapsed or refractory multiple myeloma. As a physician who treats many patients both inpatient and in the outpatient setting, the emerging safety profile of anito-cel is encouraging, in particular the absence of any delayed neurotoxicities reported to date. We are excited to begin enrolling patients in the iMMagine-3 study and in the near future having anito-cel as an approved treatment option.”
Arcellx’s Chairman and Chief Executive Officer, Rami Elghandour, said, “It’s exciting to reach this momentous milestone in our pivotal study and present these compelling data. These data, along with the data from our Phase 1 study, which demonstrated a 30.2-month median PFS and zero cases of delayed neurotoxicity or other non-ICANS neurotoxicity with all patients having more than two years of follow-up, continue to support our conviction that anito-cel has the potential to be a best-in-class treatment option for patients with RRMM. Additionally, with iMMagine-3 underway in earlier lines in a patient population representing an unmet clinical need, we expect to further position anito-cel as a differentiated CAR-T treatment option for RRMM. Separately, this year is Arcellx’s 10th anniversary! I’m grateful for the incredible people who make up the fabric of Arcellx and have poured themselves into developing this life-saving therapy for the patients most in need. And I'm proud of how we’ve done it, leaning into our diversity as a cornerstone of our culture, which underpins our success. I especially appreciate the partnership, collaboration, and trust of the Phase 1 and iMMagine-1 clinicians who helped enroll patients in these studies and allowed us to demonstrate the potential benefit of anito-cel. I’m also grateful to those who believed in us, our founding investors and scientists, our investors who helped us go public nearly three years ago in a challenging market, and those who have joined us along the way. To our colleagues at Kite, we thank you for your partnership. To everyone who’s been part of this incredible journey, thank you! We’re just getting started!”
ASH Presentation Details
Phase 2 Registrational Study of Anitocabtagene Autoleucel for the Treatment of Patients with Relapsed and/or Refractory Multiple Myeloma: Preliminary Results From the iMMagine-1 Trial (abstract #1031)
Speaker: Ciara Freeman, M.D., Ph.D., H. Lee Moffitt Cancer Center
Session Name: 655. Multiple Myeloma: Cellular Therapies: Unleashing Cell Therapies Against Myeloma
Session Date: Monday, December 9, 2024
Session Time: 4:30 p.m. - 6:00 p.m. PT
Presentation Time: 5:30 p.m. PT
Location: Marriott Marquis San Diego Marina, Pacific Ballroom Salons 24-26
Publication Number: 1031
Submission ID: 198499
Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) (abstract #4825)
Speaker: Michael R. Bishop, M.D., The University of
Session Name: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities
Session Date: Monday, December 9, 2024
Presentation Time: 6:00 p.m. - 8:00 p.m. PT
Location:
Publication Number: 4825
Submission ID: 201080
Health Related Quality of Life (HRQoL) in Relapsed/Refractory Multiple Myeloma (RRMM): A Systematic Literature Review (SLR) and Meta-Analysis (abstract #4721)
Speaker: Rahul Banerjee, M.D., Fred Hutchinson Cancer Center
Session Name: 653. Multiple Myeloma: Clinical and Epidemiological: Poster III
Session Date: Monday, December 9, 2024
Presentation Time: 6:00 p.m. - 8:00 p.m. PT
Location:
Treatment Patterns and Outcomes in Triple-Class Exposed Patients with Relapsed and Refractory Multiple Myeloma: Findings from the Flatiron Database (abstract #6962)
This abstract will be published in a supplemental issue of Blood in November 2024.
Webcast Event (New Start Time):
Arcellx will host a live webcast event with an expert panel of clinicians to discuss the clinical results on Monday, December 9, 2024 at 8 p.m. PT. The event will be accessible from the Investors section of the Company’s website at ir.arcellx.com. A webcast replay will be archived and available for 30 days following the event.
About Multiple Myeloma
Multiple Myeloma (MM) is a type of hematological cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone lesions, loss of bone density, and bone fractures. These abnormal plasma cells also produce excessive quantities of an abnormal immunoglobulin fragment, called a myeloma protein (M protein), causing kidney damage and impairing the patient’s immune function. Multiple myeloma is the third most common hematological malignancy in
About Anitocabtagene Autoleucel (anito-cel)
Anitocabtagene autoleucel (anito-cel, previously ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact binder known as the D-Domain. The small, stable D-Domain binder enables high CAR expression without tonic signaling and is designed to quickly release from the BCMA target. This combination may allow for the effective elimination of multiple myeloma cells without severe immunotoxicity. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the
About iMMagine-3, A Global Phase 3 Randomized Controlled Clinical Study
iMMagine-3 is a global Phase 3 randomized controlled study designed to compare the efficacy and safety of anitocabtagene autoleucel (anito-cel) with standard of care in patients with relapsed and/or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy, including an immunomodulatory drug (lMiD) and an anti-CD38 monoclonal antibody.
iMMagine-3 will enroll approximately 450 adult patients. Prior to randomization, investigator’s choice of standard of care (SOC) regimens include: pomalidomide, bortezomib, and dexamethasone (PVd); daratumumab, pomalidomide, and dexamethasone (DPd); carfilzomib, daratumumab, and dexamethasone (KDd); or carfilzomib and dexamethasone (Kd). Patients in the anito-cel arm will undergo leukapheresis and optional bridging therapy (with the SOC regimen selected by the investigator prior to randomization) followed by lymphodepleting chemotherapy (fludarabine 30 mg/m2/d and cyclophosphamide 300 mg/m2/d for 3 days) and one infusion of anito-cel (115×106 CAR+ T cells) on Day 1.
The primary endpoint is progression-free survival (PFS) per blinded independent review according to the 2016 IMWG uniform response criteria for multiple myeloma (MM) with the hypothesis that anito-cel will prolong PFS compared to SOC. Key secondary endpoints include complete response rate (CR/sCR), minimal residual disease negativity, overall survival, and safety.
The iMMagine-3 study was initiated in the second half of 2024 at approximately 130 study sites across
About Arcellx and Kite Collaboration
Arcellx and Kite, a Gilead Company, formed a global strategic collaboration and license agreement to co-develop and co-commercialize anito-cel for patients with relapsed and/or refractory multiple myeloma, (RRMM). Anito-cel is currently being developed in a Phase 2 registrational pivotal study and a global Phase 3 randomized controlled study for RRMM. Kite and Arcellx will jointly commercialize the anito-cel asset in
About Arcellx, Inc.
Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. Arcellx believes that cell therapies are one of the forward pillars of medicine and Arcellx's mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible. For more information on Arcellx, please visit www.arcellx.com. Follow Arcellx on X @arcellx and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements in this press release that are not purely historical are forward-looking statements, including, but not limited to, statements regarding the safety and efficacy of anito-cel, the promising clinical profile of anito-cel, the expectation of anito-cel to be a differentiated CAR-T treatment option for RRMM, the potential of anito-cel as an outpatient therapy, the potential of anito-cel to be a best-in-class treatment option for patients with RRMM, or the planned commercial development of anito-cel both inside and outside
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Investor Contact:
Myesha Lacy
Arcellx, Inc.
ir@arcellx.com
510-418-2412
Media Contact:
Andrea Cohen
Sam Brown Inc.
andreacohen@sambrown.com
917-209-7163
Source: Arcellx, Inc.
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