Arcellx to Present Clinical Data for Its Phase 1 and iMMagine-1 Studies in Patients with Relapsed or Refractory Multiple Myeloma at the 66th ASH Annual Meeting and Exposition and Announces Progress in iMMagine-3 Study
Arcellx (NASDAQ: ACLX) announced clinical data from its Phase 1 and iMMagine-1 studies for anitocabtagene autoleucel (anito-cel) in relapsed/refractory multiple myeloma patients. The Phase 1 study showed a 30.2-month median progression-free survival with 38.1 months median follow-up. The Phase 2 iMMagine-1 study demonstrated 95% overall response rate and 62% complete response rate in 58 patients at 10.3 months median follow-up. No delayed neurotoxicities were observed in over 140 patients across both studies. The company also reported the first patient dosing in the iMMagine-3 study, manufactured by Kite.
Arcellx (NASDAQ: ACLX) ha annunciato dati clinici dai suoi studi di Fase 1 e iMMagine-1 per l'anitocabtagene autoleucel (anito-cel) in pazienti con mieloma multiplo relapsi/refrattario. Lo studio di Fase 1 ha mostrato una sopravvivenza libera da progressione mediana di 30,2 mesi con un follow-up mediano di 38,1 mesi. Lo studio di Fase 2 iMMagine-1 ha dimostrato un tasso di risposta globale del 95% e un tasso di risposta completa del 62% in 58 pazienti con un follow-up mediano di 10,3 mesi. Non sono state osservate neurotossicità ritardate in oltre 140 pazienti in entrambi gli studi. L'azienda ha anche riportato la prima somministrazione di farmaco nello studio iMMagine-3, prodotto da Kite.
Arcellx (NASDAQ: ACLX) anunció datos clínicos de sus estudios de Fase 1 e iMMagine-1 para anitocabtagene autoleucel (anito-cel) en pacientes con mieloma múltiple en recaída/refractario. El estudio de Fase 1 mostró una supervivencia libre de progresión mediana de 30.2 meses con un seguimiento mediano de 38.1 meses. El estudio de Fase 2 iMMagine-1 demostró una tasa de respuesta global del 95% y una tasa de respuesta completa del 62% en 58 pacientes con un seguimiento mediano de 10.3 meses. No se observaron neurotoxicidades tardías en más de 140 pacientes en ambos estudios. La compañía también informó sobre la primera dosificación de paciente en el estudio iMMagine-3, fabricado por Kite.
Arcellx (NASDAQ: ACLX)는 재발성 및 내성 다발성 골수종 환자를 위한 anitocabtagene autoleucel (anito-cel)에 대한 1상 및 iMMagine-1 연구의 임상 데이터를 발표했습니다. 1상 연구는 30.2개월의 중앙 무진행 생존 기간과 38.1개월의 중앙 추적 관찰 기간을 보였습니다. 2상 iMMagine-1 연구는 58명의 환자 중 10.3개월의 중앙 추적 관찰 기간 동안 95%의 전체 반응률과 62%의 완전 반응률을 입증했습니다. 두 연구 모두에서 140명 이상에서 지연된 신경독성이 관찰되지 않았습니다. 이 회사는 또한 Kite에서 제조한 iMMagine-3 연구에서 첫 번째 환자 투약을 보고했습니다.
Arcellx (NASDAQ: ACLX) a annoncé des données cliniques de ses études de phase 1 et iMMagine-1 concernant l'anitocabtagène autoleucel (anito-cel) chez des patients atteints de myélome multiple en rechute/réfractaire. L'étude de phase 1 a montré une survie sans progression médiane de 30,2 mois avec un suivi médian de 38,1 mois. L'étude iMMagine-1 de phase 2 a démontré un taux de réponse global de 95 % et un taux de réponse complète de 62 % chez 58 patients avec un suivi médian de 10,3 mois. Aucune neurotoxicité retardée n'a été observée chez plus de 140 patients dans les deux études. L'entreprise a également signalé la première administration chez un patient dans l'étude iMMagine-3, fabriquée par Kite.
Arcellx (NASDAQ: ACLX) hat klinische Daten aus seinen Phase-1- und iMMagine-1-Studien für anitocabtagene autoleucel (anito-cel) bei Patienten mit rezidivierendem/refraktärem multiples Myelom veröffentlicht. Die Phase-1-Studie zeigte eine mediane progressionsfreie Überlebenszeit von 30,2 Monaten mit einem medianen Follow-up von 38,1 Monaten. Die Phase-2-Studie iMMagine-1 demonstrierte eine Gesamteantwortquote von 95 % und eine vollständige Antwortquote von 62 % bei 58 Patienten mit einem medianen Follow-up von 10,3 Monaten. In beiden Studien wurden keine verzögerten neurotoxischen Reaktionen bei über 140 Patienten beobachtet. Das Unternehmen berichtete ebenfalls über die erste Dosierung eines Patienten in der Studie iMMagine-3, die von Kite hergestellt wird.
- Phase 1 study achieved 100% overall response rate with 79% complete response rate
- Phase 2 iMMagine-1 showed 95% overall response rate with 62% complete/stringent complete response rate
- 92% of evaluable patients achieved minimal residual disease negativity in Phase 2 study
- Strong safety profile with no delayed neurotoxicities observed in over 140 patients
- 30.2-month median progression-free survival in Phase 1 study
- Three deaths occurred due to adverse events in the Phase 2 study
- 62% of patients experienced Grade ≥3 neutropenia in Phase 2 study
- 26% of patients had Grade ≥3 thrombocytopenia and anemia
Insights
The Phase 1 and iMMagine-1 trial results for anito-cel show remarkable efficacy in treating relapsed/refractory multiple myeloma. Key highlights include a
The safety profile is particularly noteworthy, with most patients experiencing either no or mild cytokine release syndrome. The absence of delayed neurotoxicities differentiates anito-cel from competing CAR-T therapies. The successful manufacturing partnership with Kite and strong preliminary data position anito-cel favorably for potential FDA approval in the RRMM market.
This data strengthens Arcellx's market position in the competitive CAR-T therapy landscape. The superior safety profile and strong efficacy metrics could translate to significant market share gains, particularly given the
The robust survival data and high response rates in heavily pretreated patients suggest anito-cel could become a preferred option in later-line RRMM treatment, where current options show efficacy (
-- 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 --
-- Preliminary results from 58 patients enrolled in the Phase 2 pivotal iMMagine-1 study demonstrated
-- No delayed neurotoxicities have been observed to date with anito-cel, including no parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome across the Phase 1 and iMMagine-1 studies in the more than 140 patients dosed --
-- First patient dosed in iMMagine-3 study, manufactured by Kite; turnaround time in line with Kite's commercial products --
-- Company to host a live webcast event with an expert panel of clinicians on Monday, December 9, 2024 at 8:30 p.m. --
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)
As detailed in the abstract (#1031) as of June 1, 2024, 58 patients had received anito-cel infusion with ≥2 months of follow-up after infusion, with a median follow-up of 10.3 months (range, 2.0-17.8). The median age was 66 years (range, 38-77). Patients had received a median of four prior lines of treatment (range, 3-8) with 26 patients (
Investigator-assessed overall response rate (ORR) per International Myeloma Working Group (IMWG) criteria was
No delayed neurotoxicities, including no parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome have been observed to date. Forty-six patients (
Conclusions
Preliminary results from the first 58 patients in the Phase 2 iMMagine-1 study demonstrate deep and durable responses and manageable safety in a high-risk fourth line or higher (4L+) RRMM population including triple- and penta-class refractory disease. Notably, no delayed neurotoxicities, including no cranial nerve palsies, Guillain-Barré syndrome, or Parkinsonian-like symptoms have been observed with anito-cel to date. Updated Phase 2 data with a more recent data cut will be presented at the oral presentation during ASH.
Presentation details: |
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. |
Presentation Time: 5:30 p.m. |
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)
In the Phase 1 study, 40 patients were enrolled and 38 patients received anito-cel. All 38 patients demonstrated investigator-assessed clinical response per 2016 IMWG criteria, (ORR,
Presentation details: |
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. |
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)
Quantifying pre-treatment HRQoL burden is important as a reference for contextualizing baseline patient burden as emerging therapies for RRMM continue to evolve. This SLR synthesized studies that reported data for key multiple myeloma HRQoL instruments. It found that patients with RRMM had clinically meaningful impairments from population norms in important domains, such as Global Health Status and cognitive, physical, and emotional functioning. The SLR also found that pre-treatment HRQoL worsened with increasing lines of therapy.
Presentation details: |
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. |
Location: |
Treatment Patterns and Outcomes in Triple-Class Exposed Patients with Relapsed and Refractory Multiple Myeloma: Findings from the Flatiron Database (abstract #6962)
In order to understand the contemporary unmet need in the rapidly evolving treatment landscape for patients with triple-class exposed RRMM - those exposed to immunomodulatory drugs, proteasome inhibitors, and anti-CD38 monoclonal antibodies - in the 4L+ setting, a retrospective cohort study using the Flatiron Health electronic health record (HER) was conducted (sample size=594). This study found no clear standard of care in the 4L+ setting, and suboptimal health outcomes under the current treatment landscape (ORR=
This abstract will be published in a supplemental issue of Blood in November 2024.
Webcast Event:
Arcellx will host a live webcast event with an expert panel of clinicians to discuss the clinical results on Monday, December 9, 2024 at 8:30 p.m. PT. The event will be accessible from Arcellx's website at www.arcellx.com in the Investors section. 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. 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 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 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 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 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 Arcellx’s plans for the clinical development of its product candidates; anticipated announcements of additional data; anito-cel tolerability and toxicity trends; Arcellx’s competitive positioning; expectations regarding manufacturing time; the potential commrical launch of anito-cel, subject to FDA approval; and the potential impact of Arcellx’s product candidates and platforms on patients and cell therapy. The forward-looking statements contained herein are based upon Arcellx’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including those set forth in Part II, Item 1A (Risk Factors) in the Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the Securities and Exchange Commission (SEC) on August 8, 2024, and the other documents that Arcellx may file from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Arcellx assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.
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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.
FAQ
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