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

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

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. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Immunology • Myasthenia Gravis • Oncology

Anitocabtagene autoleucel: “Ph2 iMMagine-1 ASH Update”; Multiple myeloma (Gilead, 43rd Annual J.P. Morgan Healthcare Conference)

P2 data • Hematological Malignancies • Multiple Myeloma • Oncology

Anitocabtagene autoleucel: “Ph2 iMMagine-1 ASH Update”; Multiple myeloma (Gilead, 43rd Annual J.P. Morgan Healthcare Conference)

P2 data • Hematological Malignancies • Multiple Myeloma • Oncology

Prior ASCT May Impact Outcomes of CAR T-Cell Therapy in MM (Cancer Therapy Advisor) - P=NA | N=158 | "Researchers found that MM patients with a history of HDM/ASCT had significantly shorter progression-free survival (PFS) after BCMA-directed CAR T-cell therapy than patients who had not received HDM/ASCT. These findings were presented at the ASH Annual Meeting 2024...The CAR T-cell therapies patients received were idecabtagene vicleucel, ciltacabtagene autoleucel, and anitocabtagene autoleucel...There were no significant differences in response between the groups. The overall response rate was 83% in the transplant recipients and 88% in the patients who had not received a prior transplant (P =.37). Rates of complete response were 40% and 48%, respectively (P =.12)....Similarly, there was no significant difference in overall survival (OS) between the groups. The median OS was 34.2 months in transplant recipients and was not reached in patients who had not received a prior transplant (P =.43). The 18-month OS rates were 49% and 58%, respectively."

Clinical data • Hematological Malignancies • Multiple Myeloma • Oncology

Efficacy and Safety of Chimeric Antigen Receptor T-Cell Therapy in Relapsed and Refractory Multiple Myeloma – a Meta-Analysis (ASH 2024) - "We included 7 trials each of Ciltacabtagene autoleucel (cilta-cel) and Idecabtagene vicleucel (ida-cel) while 21 trials used different CAR-T cell therapies including GPRC5D, HDS269B, C-CAR088, HBI0101, CART-ddBCMA, ALLO-715, ARI0002h. This analysis has limitations with significant heterogeneity among studies. There were different CAR T-cell therapies with diverse designs of studies which limit the generalization of results."

CAR T-Cell Therapy • Retrospective data • Anemia • Bone Marrow Transplantation • Cardiovascular • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukopenia • Multiple Myeloma • Neutropenia • Oncology • Thrombocytopenia

Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells (clinicaltrials.gov) - P=N/A | N=1000 | Enrolling by invitation | Sponsor: Kite, A Gilead Company | N=700 ➔ 1000

Enrollment change • Hematological Disorders • Hematological Malignancies • Oncology

Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Patients with Relapsed and/or Refractory Multiple Myeloma (RRMM): Efficacy and Safety with 34-Month Median Follow-up (ASH 2024) - P2, P3 | "Methods : Pts with RRMM who had received ≥3 prior lines of therapy (LoT) were enrolled and received a single infusion of anito-cel following lymphodepletion chemotherapy (fludarabine 30 mg/m2 and cyclophosphamide 300 mg/m2 daily for 3 days). Follow-up is continuing and updated data will be presented. Further investigations of anito-cel are ongoing in 4L+ RRMM (iMMagine-1, NCT05396885) and in earlier lines (iMMagine-3, NCT06413498)."

Clinical • P1 data • CNS Disorders • Complement-mediated Rare Disorders • Hematological Malignancies • Movement Disorders • Multiple Myeloma • Oncology • Parkinson's Disease • B2M

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 (ASH 2024) - P2 | "Following leukapheresis, optional bridging, and anito-cel manufacturing, pts received lymphodepletion chemotherapy (fludarabine 30 mg/m2/d and cyclophosphamide 300 mg/m2/d for 3 days) and a single infusion of anito-cel (target dose of 115×106 CAR+ viable T cells). Notably, no delayed neurotoxicity, cranial nerve palsies, Guillain Barre syndrome, or Parkinsonian-like symptoms were observed in the Phase 1 study or in the Phase 2 iMMagine-1 study to date. Updated data with additional follow-up will be presented."

Clinical • IO biomarker • P2 data • Anemia • CNS Disorders • Complement-mediated Rare Disorders • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Movement Disorders • Multiple Myeloma • Neutropenia • Oncology • Parkinson's Disease • Thrombocytopenia

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 (Businesswire) - P2 | N=110 | iMMagine-1 (NCT05396885) | Sponsor: Kite, A Gilead Company | “Preliminary results from 86 patients enrolled in the Phase 2 pivotal iMMagine-1 study of anito-cel demonstrated 97% ORR and 62% CR/sCR at a median follow-up of 9.5 months; 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...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."

P1 data • P2 data • Multiple Myeloma

Anito-cel Data from Partner, Arcellx (Businesswire) - P2 | N=110 | iMMagine-1 (NCT05396885) | "preliminary results from 58 patients in the Phase 2 iMMagine-1 study...demonstrate a 95% objective response rate (ORR) and a 62% complete response / stringent complete response (CR/sCR) at a median follow-up of 10.3 months. Additional patients with a more recent data cut for the Phase 2 iMMagine-1 study will be presented in an oral presentation."

P2 data • Hematological Malignancies • Multiple Myeloma • Oncology

Arcellx…Announces Progress in iMMagine-3 Study (Businesswire) - "First patient dosed in iMMagine-3 study...The iMMagine-3 study initiated in the second half of 2024 at approximately 130 study sites across North America, Europe, and the rest of the world."

Trial status • Hematological Malignancies • Multiple Myeloma • Oncology

Anito-cel Data from Partner, Arcellx (Businesswire) - P1 | N=40 | NCT04155749 | Sponsor: Kite, A Gilead Company | "Key presentations for anitocabtagene autoleucel (anito-cel) include data from the Phase 1 study that demonstrate a 30.2-month median progression-free survival (PFS) with a median follow-up of 38.1 months and the median overall survival not yet reached."

P1 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 | Not yet recruiting | Sponsor: Arcellx, Inc.

New P1 trial • CNS Disorders • Immunology • Myasthenia Gravis • Oncology

Phase 1 Study Of Anitocabtagene Autoleucel For The Treatment Of Patients With Relapsed And/Or Refractory Multiple Myeloma: Results From At Least 1-year Follow-up In All Patients (IMW 2024) - "Adverse events with anito-cel, including CRS & ICANS, were manageable; no off-tumor tissue-targeted toxicity, delayed neurotoxicity nor Parkinsonian-like events were observed at time of data-cut. Efficacy analyses demonstrated 100% ORR, including 92% with VGPR or better & 76% with CR/sCR. Clinical responses were durable with an overall estimated 24-mo PFS rate of 56% with comparable responses seen in pts with 'high-risk' disease characteristics."

Clinical • P1 data • CNS Disorders • Hematological Malignancies • Movement Disorders • Multiple Myeloma • Oncology • Parkinson's Disease • B2M

iMMagine-3: A Phase 3, Randomized Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel (Anito-Cel) With Standard of Care in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) (IMW 2024) - P2, P3 | "Before randomization, investigators will select one of the following SOC regimens: pomalidomide (P), bortezomib (V), and dexamethasone (d; PVd); daratumumab (D), P, and d (DPd); carfilzomib (K), D, and d (KDd); or K and d (Kd)...Pts in the anito-cel arm will undergo leukapheresis and optional bridging therapy (with the selected SOC regimen at discretion of the investigator) followed by lymphodepleting chemotherapy (fludarabine 30 mg/m2/d and cyclophosphamide 300 mg/m2/d for 3 d) and one infusion of anito-cel (115×106 CAR+ T cells) on D1... iMMagine-3 is enrolling soon."

Clinical • IO biomarker • P3 data • Bone Marrow Transplantation • Gene Therapies • Hematological Malignancies • Multiple Myeloma • Oncology

Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Patients With Relapsed and/or Refractory Multiple Myeloma: Results From at Least 1-Year Follow-Up in all Patients (SOHO 2024) - "Adverse events with anito-cel were manageable and resolved; no delayed neurotoxicity, cranial nerve palsies, nor Parkinsonian-like events were observed at time of data-cut. Efficacy analyses demonstrated 100% ORR, with 76% ≥CR. Responses were durable with an estimated 24-month PFS rate of 56% and comparable outcomes in patients with high-risk disease."

Clinical • P1 data • Hematological Malignancies • Multiple Myeloma • Oncology • B2M

iMMagine-3: A Phase 3, Randomized Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel (Anito-Cel) With Standard of Care in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) (SOHO 2024) - P3 | "Before randomization, investigators will select a SOC regimen: pomalidomide, bortezomib, and dexamethasone; daratumumab, pomalidomide, and dexamethasone; carfilzomib, daratumumab, and dexamethasone; or carfilzomib and dexamethasone. iMMagine-3 is enrolling soon."

Clinical • P3 data • Hematological Malignancies • Multiple Myeloma • Oncology

iMMagine-3: A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma (clinicaltrials.gov) - P3 | N=450 | Recruiting | Sponsor: Kite, A Gilead Company | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

Arcellx Provides Second Quarter 2024 Financial Results and Business Updates (Businesswire) - "Recent Business Progress: The Company earned a $68 million clinical milestone payment from Kite Pharma, Inc., a Gilead Company, for iMMagine-1 enrollment. The Company submitted an abstract to present data for the iMMagine-1 study at the 66th ASH Annual Meeting and Exposition. Kite has initiated the global Phase 3 trial, iMMagine-3. This trial will evaluate anito-cel in patients exposed to an immunomodulatory (lMiD) drug and an anti-CD38 monoclonal antibody."

Financing • P2 data • Trial status • Multiple Myeloma

Arcellx Provides Second Quarter 2024 Financial Results and Business Updates (Businesswire) - "The U.S. Food and Drug Administration (FDA) cleared an Investigational New Drug (IND) application for anito-cel, Arcellx’s BCMA CAR-T therapy, for myasthenia gravis, a chronic autoimmune disease."

IND • Immunology • Myasthenia Gravis

PHASE 1 STUDY OF ANITOCABTAGENE AUTOLEUCEL FOR THE TREATMENT OF PATIENTS WITH RELAPSED AND/OR REFRACTORY MULTIPLE MYELOMA: RESULTS FROM AT LEAST 1-YEAR FOLLOW-UP IN ALL PATIENTS (EHA 2024) - "Adverse events with anito-cel, including CRS & ICANS, were manageable; no off-tumor tissue-targeted toxicity,delayed neurotoxicity or Parkinsonian-like events were observed at time of data-cut. Efficacy analysesdemonstrated 100% ORR, including 92% with VGPR or better & 76% with CR/sCR. Clinical responses weredurable with an overall estimated 24-mo PFS rate of 56% with comparable responses seen in pts with 'high-risk' disease characteristics."

Clinical • P1 data • CNS Disorders • Hematological Malignancies • Movement Disorders • Multiple Myeloma • Oncology • Parkinson's Disease • B2M

IMMAGINE-3: A PHASE 3, RANDOMIZED STUDY TO COMPARE THE EFFICACY AND SAFETY OF ANITOCABTAGENE AUTOLEUCEL (ANITO-CEL) WITH STANDARD OF CARE IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM) (EHA 2024) - P2 | "Prior torandomization, the investigator will select one of the following SOC regimens: pomalidomide (P), bortezomib(V), and dexamethasone (d; PVd); daratumumab (D), P, and d (DPd); carfilzomib (K), D, and d (KDd); or K andd (Kd)...Pts in the anito-celarm will undergo leukapheresis and optional bridging therapy (with the selected SOC regimen at discretion ofthe investigator) followed by lymphodepleting chemotherapy (fludarabine 30 mg/m2/d andcyclophosphamide 300 mg/m2/d for 3 days) and one infusion of anito-cel (115×106 CAR+ T cells) on Day 1... iMMagine-3 will be enrolling soon."

Clinical • IO biomarker • P3 data • Gene Therapies • Hematological Malignancies • Multiple Myeloma • Oncology