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FDA grants regenerative medicine advanced therapy designation to acimtamig and AB101 combination for R/R cHL
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On December 5, 2024, it was announced that the U.S. Food and Drug Administration (FDA) granted regenerative medicine advanced therapy designation to a combination of acimtamig, a bispecific innate cell engager, and AB101, an allogeneic natural killer cell, for the treatment of patients with relapsed/refractory (R/R) classical Hodgkin lymphoma (cHL). This approval is based on positive results from the phase II LuminICE-203 trial (NCT05883449).1
Key data from the LuminICE-203 trial1
The LuminICE-203 trial is a multicenter, open-label, phase II study evaluating the efficacy and safety of acimtamig in combination with AB-101 in patients with R/R cHL and CD30-positive peripheral T-cell lymphoma. Among the evaluable patients with cHL (n = 12):
- The overall response rate was 83.3%.
- The complete response rate was 50%.
- The safety profile was manageable.
- GlobeNewswire. Affimed announces acimtamig and alloNK® combination granted regenerative medicine advanced therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA). https://www.globenewswire.com/news-release/2024/12/05/2992178/0/en/Affimed-Announces-Acimtamig-and-AlloNK-Combination-Granted-Regenerative-Medicine-Advanced-Therapy-RMAT-Designation-by-the-U-S-Food-and-Drug-Administration-FDA.html. Published Dec 5, 2024. Accessed Dec 9, 2024.
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