Affimed’s AFM13 + AlloNK Receives the US FDA’s Fast Track Designation for Relapsed or Refractory Hodgkin Lymphoma
Shots:
- The US FDA has granted fast-track designation to the combination of AFM13 (innate cell engager) + AlloNK for the treatment of r/r HL
- The combination therapy will be studied in the P-II (LuminICE-203) study evaluating the efficacy and safety for r/r HL. The study also incl. an exploratory cohort of CD30+ peripheral T-cell lymphoma patients
- This P-II study was built on the clinical results from the P-I/II trial (AFM13-104) of AFM13 + cord blood-derived natural killer cells which showed an outstanding clinical result in late-stage, multi-refractory, ORR (94%), CR rate (71%) and a well-managed safety profile at RP2D specifically while ORR and CR were 97% and 77%, respectively in the 31 r/r HL treated patients
Ref: affimed | Image: affimed
Related News:- Affimed Reports First Patient Dosing of AFM28 in the P-I Study for the Treatment of CD123-Positive Acute Myeloid Leukemia
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