Allogene Therapeutics to present updated ALLO-316 results at ASCO meeting

Allogene Therapeutics (ALLO) announced that it will present updated data from the completed Phase 1 TRAVERSE trial of ALLO-316 in an oral presentation at the 2025 American Society of Clinical Oncology Annual Meeting, taking place May 29-June 2 in Chicago, Illinois. The trial evaluated ALLO-316 in patients with advanced or metastatic renal cell carcinoma who had progressed following immune checkpoint inhibitor and VEGF-targeted therapies. In addition, a trial-in-progress poster is also being presented to highlight the ongoing pivotal Phase 2 ALPHA3 trial, which is evaluating cemacabtagene ansegedleucel as part of first-line treatment for patients with large B-cell lymphoma.ALLO-316 is an allogeneic, “off-the-shelf” CAR T product targeting CD70 and is the only allogeneic CAR T product to demonstrate potential in solid tumors. Data from the Phase 1 TRAVERSE trial previously showed a manageable safety profile and encouraging anti-tumor activity in heavily pretreated patients with advanced or metastatic CD70+ RCC. Enrollment is now complete in the Phase 1b expansion cohort, which evaluated the safety and efficacy of ALLO-316 at dose level 2 following a standard lymphodepletion regimen of cyclophosphamide and fludarabine. The ALPHA3 trial is the first pivotal study to evaluate an allogeneic CAR T product as a consolidation strategy aimed at eradicating minimal residual disease following 1L treatment in LBCL. It is assessing cema-cel in patients with MRD after standard 1L chemoimmunotherapy, such as R-CHOP, with the goal of improving 1L cure rates. The trial identifies patients at high risk for relapse after 1L treatment by utilizing Foresight CLARITY, powered by PhasED-Seq, a novel Investigational Use Only test for MRD. This randomized trial will enroll approximately 240 patients and is designed to demonstrate a meaningful improvement in event free survival in patients treated with cema-cel relative to patients who receive the current standard of care.