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Affimed’s AFM13 + AlloNK Receives the US FDA’s Fast Track Designation for Relapsed or Refractory Hodgkin Lymphoma

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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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Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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