AFMD - Affimed Announces Oral Presentation of Phase 1/2 Data from AFM13 in Combination with Allogeneic NK Cells at the 2023 ASH Annual Meeting | Benzinga
- In 36 patients with CD30-positive lymphoma treated at the recommended Phase 2 dose level (RP2D), the combination treatment of AFM13 with allogeneic NK cells shows a 94.4% objective response rate and a 72.2% complete response rate as of the July 2023 cut-off date for data included in the abstract
- Patients were heavily pretreated (median of 7 prior lines) and refractory to their most recent line of therapy
- Patients received up to four cycles and the treatment was well tolerated
- Updated clinical results including data on event free survival and overall survival with a later cut-off date will be given in an oral presentation on Monday, December 11, 2023 at 11:45 a.m. Pacific Standard Time (PST)
MANNHEIM, Germany, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (NASDAQ:AFMD) ("Affimed", or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced two upcoming presentations on its lead innate cell engager (ICE®) AFM13 at the American Society of Hematology (ASH) 2023 Annual Meeting.
In the first presentation, Yago Nieto, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at The University of Texas MD Anderson Cancer Center and principal investigator of the study, will present the updated results from the AFM13-104 phase 1/2 trial evaluating AFM13 in combination with cord blood-derived natural killer (cbNK) in patients with CD30-positive relapsed or refractory (r/r) Hodgkin and non-Hodgkin lymphomas in an oral presentation, on Monday, December 11, 2023 at 11:45 a.m. PST / 2:45 p.m. EST.
A total of 42 patients were enrolled in the study with 36 patients treated at the RP2D. All patients were heavily pretreated and refractory to their most recent line of therapy with active progressive disease at the time of enrollment. As of the July 2023 cut-off date for data presented in the abstract, the treatment regimen achieved an objective response rate (ORR) of 94.4% with a complete response rate of 72.2% in the patients treated at the RP2D. In addition, the treatment regimen demonstrated a good safety and tolerability profile with no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) or graft versus host disease (GVHD) of any grade.
Across all dose levels as of the cutoff date, median event free survival (EFS) and overall survival (OS) were 8 months and not reached, respectively. A more in-depth analysis of the data and updated EFS/OS data using a later cut-off date will be presented during Dr. Nieto's oral presentation.
The second presentation will be a poster featuring the design of Affimed's phase 2 LuminICE-203 clinical trial investigating AFM13 in combination with Artiva's AlloNK® (also known as AB-101), an allogeneic, non-genetically modified NK cell therapy candidate. The open-label, multi-center, multi-cohort study (NCT05883449) study is based on the unprecedented results achieved in the investigational AFM13-104 study and will evaluate the efficacy and safety of the combination in patients with r/r HL and certain r/r CD30+ PTCL subtypes. Affimed has recently received Fast-track designation for the AFM13/AB-101 combination.
"AFM13 ...