Allogene Therapeutics to Present Updated ALLO-316 Clinical Results in Kidney Cancer in Oral Presentation and ALPHA3 Trial-in-Progress Poster for Cema-Cel at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

Core Insights - Allogene Therapeutics is presenting updated data from the Phase 1 TRAVERSE trial of ALLO-316 at the 2025 ASCO Annual Meeting, focusing on advanced renal cell carcinoma (RCC) patients who have progressed after prior therapies [1][4] - The company is also showcasing a trial-in-progress poster for the pivotal Phase 2 ALPHA3 trial, which evaluates cemacabtagene ansegedleucel (cema-cel) as a first-line treatment for large B-cell lymphoma (LBCL) [1][4] ALLO-316 Overview - ALLO-316 is an allogeneic CAR T product targeting CD70, showing potential in solid tumors, specifically in advanced or metastatic CD70+ RCC [2][6] - The Phase 1 TRAVERSE trial has demonstrated a manageable safety profile and encouraging anti-tumor activity in heavily pretreated patients [2][7] - Enrollment is complete for the Phase 1b expansion cohort, which is assessing the safety and efficacy of ALLO-316 at a dose of 80 million CAR T cells [2][7] ALPHA3 Trial Details - The ALPHA3 trial is the first pivotal study to evaluate an allogeneic CAR T product as a consolidation strategy for eradicating minimal residual disease (MRD) in LBCL patients after first-line treatment [3][8] - The trial aims to improve first-line cure rates by identifying high-risk patients using a novel MRD test and enrolling approximately 240 patients [3][8] - Cema-cel is positioned as a potential "7th cycle" of frontline treatment for eligible patients with MRD following standard therapy [8] Regulatory Designations - Both ALLO-316 and cema-cel have received Regenerative Medicine Advanced Therapy (RMAT) designations from the FDA, indicating their potential to address unmet medical needs [7][5] - The ALPHA3 trial launched in June 2024, with cema-cel having previously received RMAT designation in June 2022 [5][7] Company Background - Allogene Therapeutics is a clinical-stage biotechnology company focused on developing allogeneic CAR T products for cancer and autoimmune diseases [9] - The company aims to provide readily available cell therapy on-demand, enhancing treatment accessibility and reliability for patients [9]