- Allogene Therapeutics to present updated ALLO-316 Phase 1 and ALPHA3 Phase 2 trial data at ASCO 2025.
- ALLO-316 shows potential in solid tumors with positive safety and anti-tumor activity in RCC.
- ALPHA3 aims to improve LBCL treatment, enrolling 240 patients for first-line consolidation therapy.
Allogene Therapeutics, Inc. (NASDAQ: ALLO), a leader in allogeneic CAR T cell therapies, is set to present significant updates from two key clinical trials at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The event will take place from May 29 to June 2 in Chicago, Illinois, and will showcase advancements in cancer treatment strategies.
The first presentation will deliver updated results from the completed Phase 1 TRAVERSE trial of ALLO-316, which is the only allogeneic CAR T product demonstrating potential efficacy in solid tumors, specifically targeting CD70 in renal cell carcinoma (RCC). Previous data indicated a manageable safety profile and encouraging anti-tumor activity in patients who had been heavily pretreated with immune checkpoint inhibitors and VEGF-targeted therapies. Importantly, the Phase 1b expansion cohort, assessing 80 million CAR T cells, has now completed enrollment.
Concurrently, Allogene will highlight the pivotal Phase 2 ALPHA3 trial for cemacabtagene ansegedleucel (cema-cel) in large B-cell lymphoma (LBCL). This groundbreaking trial is notable for being the first to evaluate an allogeneic CAR T product as a first-line consolidation strategy aimed at eliminating minimal residual disease (MRD) following standard initial treatment. The trial targets 240 participants and utilizes advanced MRD detection technology, aiming to boost event-free survival rates compared to the current standard of care.
The ALPHA3 trial employs the Foresight CLARITYâ„¢ test powered by PhasED-Seqâ„¢ to identify MRD in patients at high risk for relapse. By addressing this unmet need, the study seeks to position cema-cel as a critical component of the initial treatment protocol for LBCL, representing a potential paradigm shift in how this aggressive form of cancer is managed.
