Allogene Therapeutics(US:ALLO) Newsfilter·2025-02-13 21:30Core Insights - Allogene Therapeutics has published data from its Phase 1 ALPHA and ALPHA2 clinical studies of cemacabtagene ansegedleucel (cema-cel) for relapsed/refractory large B-cell lymphoma, marking a significant advancement in allogeneic CAR T therapy [1][2] Study Overview - The ALPHA/ALPHA2 studies were single-arm, multicenter, open-label, Phase 1 trials involving 87 heavily pretreated patients with relapsed/refractory non-Hodgkin lymphoma treated between May 2019 and September 2022 [3] - The focus was on 33 CD19 CAR T-naive patients who received cema-cel manufactured for pivotal studies [3] Efficacy Results - The overall response rate (ORR) was 58% and the complete response (CR) rate was 42% across the study, with the pivotal study regimen achieving ORR and CR rates of 67% and 58% respectively [4][5] - Among patients achieving CR, the median duration of response (DOR) was 23.1 months, with median overall survival (OS) not reached [4][5] Safety Profile - The safety profile was manageable and consistent with approved autologous CD19 CAR T therapies, with no cases of graft-versus-host disease (GvHD), immune effector cell-associated neurotoxicity syndrome (ICANS), or high-grade cytokine release syndrome (CRS) reported [4][5] - Common treatment-emergent adverse events included neutropenia (85%), anemia (67%), and infusion-related reactions (58%) [6] Treatment Timing - The median time to treatment initiation was two days from enrollment, significantly shorter than the typical wait times for autologous CAR T therapies [6] Low Disease Burden Potential - In patients with low disease burden, the CR rate was 100% for those with baseline tumor burden <1000 mm² and 82% for those with normal lactate dehydrogenase levels, indicating cema-cel's promise in treating minimal residual disease (MRD) [7] Foundation for Future Trials - The ongoing ALPHA3 trial is evaluating cema-cel as a consolidation therapy for LBCL patients in remission but positive for MRD, aiming to predict and intervene before relapse [8][9] - The ALPHA3 trial is designed to establish cema-cel as a potential standard "7th cycle" of frontline treatment for patients with MRD following initial therapy [11] Product Information - Cemacabtagene ansegedleucel (cema-cel) is an investigational anti-CD19 AlloCAR T™ product, which received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for relapsed/refractory LBCL [10]