Amulirafusp Alfa Plus Lenalidomide Shows Promising Response Rates for Relapsed/Refractory Follicular Lymphoma
A novel combination of amulirafusp alfa and lenalidomide demonstrated encouraging early clinical activity with an acceptable safety profile among patients with relapsed/refractory (R/R) CD20-positive follicular lymphoma (FL), according to results from an ongoing phase 2 trial.
These data were presented by Yan Huang, MD, Jiangxi Cancer Hospital, Nanchang, China, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
Amulirafusp alfa is a bifunctional fusion protein composed of an anti-CD20 monoclonal antibody and the CD47-binding domain of SIRPα. This study evaluated the use of amulirafusp alfa in combination with lenalidomide among patients with grade 1 to 3a FL who had received a median of 2 prior lines of therapy and had prior exposure to anti-CD20 therapy.
Overall, 34 patients with R/R FL were included, and 22 were efficacy-evaluable patients. The median age was 54 years and 94.1% of patients had stage 3 or 4 disease. The overall response rate (ORR) was 81.8%, including a complete response rate (CRR) of 45.5%. Among 4 patients who did not respond to treatment, 2 had stable disease and were refractory to prior CD20 therapy, 1 patient had progressive disease (PD) and had histologic transformation, and another PD patient had long-term prior lenalidomide exposure.
In terms of safety, the most common treatment-related adverse events were decreases in platelets (70.6%), white blood cells (58.8%), neutrophil count (52.9%) lymphocyte count (52.9%), as well as, anemia (52.9%), infusion-related reactions (35.3%), and hypoalbuminemia (23.5%) Grade ≥3 treatment-related adverse events occurred in 64.7% of patients.
Pharmacokinetic and immunogenicity profiles were comparable between monotherapy and combination arms, and pharmacodynamic analysis demonstrated depletion of peripheral CD19+ B cells.
“Amulirafusp alfa in combination with lenalidomide showed a preliminary anti-tumor activity and a well-tolerated safety profile in patients with R/R FL,” the researchers concluded.
Source:
Huang Y, Liu Y, He H, et al. Phase II safety and preliminary efficacy of amulirafusp alfa (IMM0306) in combination with lenalidomide in patients with relapsed or refractory CD20-positive follicular lymphoma. Presented at 2025 ASCO Annual Meeting. May 30-June 3, 2025; Chicago, IL. Abstract 7051.
