Results from the completed dose-finding part of phase 2 study of the innate cell engager acimtamig (AFM13) in combination with AlloNK (AB-101) in relapsed or refractory classical Hodgkin lymphoma (LuminICE-203).
Year: 2025
Type: conference-abstract
Abstract: 7008 Background: There is an unmet need for new treatment approaches for patients (pts) with relapsed or refractory (R/R) classical Hodgkin lymphoma (HL) who progress following standard systemic therapies. Combining acimtamig (AFM13), a tetravalent bispecific CD30/CD16A innate cell engager (ICE), with AlloNK (AB-101), a cryopreserved, off-the-shelf, cord blood-derived NK cell product, induces antibody-dependent cellular cytotoxicity against CD30+ lymphoma cells. Methods: This Phase 2, open-label, multi-center, multi-cohort study (LuminICE-203; NCT05883449) is evaluating the efficacy and safety of acimtamig in combination with AlloNK in pts with R/R HL. An initial dose-finding part with 4 cohorts is investigating 2 doses of acimtamig (200 mg or 300 mg weekly flat dosing for 6 weeks) in combination with AlloNK (dose level 1 [DL1]: 3 doses of 2×10 9 cells on Days 1, 8 and 15; or dose level 2 [DL2]: 1 dose of 4×10 9 on Day 1, followed by 2 doses of 2×10 9 cells on Days 8 and 15), after a standard lymphodepletion up to 3 cycles, followed by a randomized part using a Simon’s 2-stage design. The primary endpoint is objective response rate (ORR) assessed by an Independent Radiology Committee (IRC) based on PET-CT per Lugano classification criteria. Results: As of 16 December 2024, 24 pts with R/R HL were treated in the initial dose-finding part of the study and were assessed by the IRC for metabolic response. Median (range) age was 42.5 (23–80) years; 16 (67%) were male. All pts in the study were heavily pretreated with chemotherapy, brentuximab vedotin and PD-1 inhibitors; median (range) prior treatment lines was 4.5 (2–13), including previous stem cell transplant in 14 (58%) pts. An ORR of 88% was achieved with 14 (58%) complete responses (CR) (Table). The safety profile was in line with that previously reported, with mostly mild to moderate infusion related reactions as the most common reported treatment-related adverse event (TRAE) in 50% of patients; no fatal TRAEs and no stopping criteria have been observed. The study is ongoing and updated safety and efficacy results, including pharmacokinetic / pharmacodynamic analyses and preliminary results on duration of response will be presented. Conclusions: Acimtamig in combination with AlloNK shows promising efficacy with a well-managed safety profile with the potential to address an unmet need in pts with R/R HL who have exhausted standard-of-care treatment options. Clinical trial information: NCT05883449 . Efficacy results of acimtamig plus AlloNK in pts with R/R HL. Efficacy, n (%)(Best Response per Lugano Criteria) AlloNK DL1+ 200 mg acimtamig(N=6) AlloNK DL1+ 300 mg acimtamig(N=6) AlloNK DL2+ 200 mg acimtamig(N=6) AlloNK DL2+ 300 mg acimtamig(N=6) Totaldose-finding part(N=24) CR 4 (67) 3 (50) 4 (67) 3 (50) 14 (58) ORR 5 (83) 5 (83) 6 (100) 5 (83) 21 (88)
Source: Journal of Clinical Oncology
Authors: Joseph E. Maakaron, Tatyana A. Feldman, Todd A. Fehniger, Gunjan L. Shah, Amitkumar Mehta, Dipenkumar Modi, Matthew Genyeh Mei, Craig Sauter, Rashmi Khanal, Stefan K. Barta, Joseph Maly, Michael Emig, Lydia Wunderle, Andre Overesch, Kerstin Pietzko, Alexandra Vasile, Jennifer Rubel, Thorsten Graef, Heather Raymon, Alison J. Moskowitz
Institutions: University of Minnesota, Masonic Cancer Center, Hackensack Meridian Health, Hackensack Meridian School of Medicine, Washington University in St. Louis, Memorial Sloan Kettering Cancer Center, University of Alabama at Birmingham, Wayne State University, The Barbara Ann Karmanos Cancer Institute, City Of Hope National Medical Center, Cleveland Clinic, Fox Chase Cancer Center, University of Pennsylvania, Norton Healthcare
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4410820716