Allogene Therapeutics Expands Cancer Drug Trial to South Korea and Australia

Allogene Therapeutics has expanded its pivotal Phase 2 ALPHA3 study to include clinical trial sites in South Korea and Australia. The biotechnology company is developing allogeneic CAR T-cell (AlloCAR T) products for cancer and autoimmune diseases.

The trial is evaluating cemacabtagene ansegedleucel (cema-cel) as a first-line consolidation treatment for patients diagnosed with large B-cell lymphoma (LBCL). With the addition of these new regions, the study will now enroll patients at over 80 global sites, up from more than 60 sites previously operating in North America.

"Expanding into South Korea and Australia allows us to leverage regions with established clinical research infrastructure and experienced investigators," said Dr. David Chang, President, CEO, and Co-Founder of Allogene. He added that these countries offer high-quality trial environments and efficient healthcare systems, which are expected to support continued enrollment and global development of cema-cel.

Earlier interim futility analysis data for cema-cel showed a significant reduction in minimal residual disease (MRD) compared to the standard-of-care observation arm. The ALPHA3 study is projected to enroll approximately 220 patients by the end of 2027, with positive results potentially supporting a Biologics License Application (BLA) submission.