Affimed Says FDA Grants Fast Track Designation For AFM13 With AlloNK To Treat R/r Hodgkin Lymphoma

(RTTNews) - Immuno-oncology company Affimed N.V. (AFMD) announced that the FDA has granted fast track designation to the combination of its innate cell engager (ICE) AFM13 with AlloNK for the potential treatment of relapsed/refractory (r/r) Hodgkin lymphoma (HL).

The combination treatment is entering Phase 2 development and will be investigated in Affimed's LuminICE-203 study (NCT05883449), which received IND-clearance earlier this year. The study also includes an exploratory cohort of CD30-positive peripheral T-cell lymphoma patients.

The FDA's decision is based on available data showing the potential of the AFM13 and AlloNK combination therapy to overcome current limitations in the treatment of r/r HL.

LuminICE-203 builds on the clinical findings from the phase 1/2 AFM13-104 trial (NCT04074746), in which investigators assessed AFM13 in combination with cord blood-derived natural killer cells in heavily pretreated patients with CD30-positive Hodgkin lymphoma and non-Hodgkin lymphoma.

Data presented to date from this trial have shown outstanding clinical results in late-stage, multi-refractory, patients with a 94% overall response rate (ORR), a 71% complete response (CR) rate and a well-managed safety profile at the recommended phase 2 dose (RP2D).