FDA Endorses Imugene’s Azer-cel for Pivotal Phase 3 in Hard-to-Treat Lymphoma

• FDA supports Phase 3 registrational study for azer-cel in third-line and later DLBCL
• Endorsed dosing regimen includes lymphodepletion and low-dose IL-2
• Dual endpoints – Overall Response Rate for accelerated approval, Progression Free Survival for full approval
• Clinical data show 82%-83% response rates in CAR-T relapsed and naïve patients