Imugene CEO Leslie Chong talked with Proactive about the latest clinical progress for its cancer immunotherapy candidate azer-cel.
Chong shared compelling data from the company’s Phase 1B trial, showing an 81% response rate in relapsed/refractory DLBCL patients who had failed autologous CAR-T therapy. In addition, Imugene reported an 83% response rate in a niche patient group that is CAR-T naive — a population where no approved CAR-T therapy currently exists.
“These are profound results,” said Chong. “It really showcases azer-cel in multiple blood cancer types, not only in DLBCL but also in marginal zone and primary CNS lymphoma.”
Imugene is preparing for a key meeting with the US FDA in November to discuss the design and pathway for a pivotal Phase 2/3 study. Chong noted the significance of securing this FDA meeting, stating the company has “put together a beautiful briefing document” to support azer-cel’s development in both relapsed and CAR-T naive settings.
The company will also present updated azer-cel data at the American Society of Hematology (ASH) Annual Meeting in December, where it has been selected for a rare oral presentation — a strong indicator of peer recognition.
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