822P - Preliminary results from a phase Ib study of amulirafusp alfa (IMM0306) in combination with lenalidomide in patients with relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma

Background

Amulirafusp alfa (IMM0306) is a fusion protein of CD20 monoclonal antibody with the CD47 binding domain of SIRPα added on the N-terminus of both heavy chains. It exerts excellent cancer killing efficacy by activating both macrophages and NK cells via blockade of CD47-SIRPα interaction and FcɣR engagement. Lenalidomide was approved for relapsed or refractory (R/R) indolent non-Hodgkin's lymphoma (iNHL). Here, we report preliminary results of phase I study of Amulirafusp alfa in combination with lenalidomide in patients (pts) with R/R CD20-positive B-cell NHL.

Methods

This study (NCT05771883) adopted a “3+3” scheme for dose escalation exploring in 2 dose level Amulirafusp alfa (1.6 and 2.0 mg/kg), intravenously administered each week and lenalidomide was orally administered at daily dose of 20 mg on Days 1-21 of a 28-day cycle until disease progression or intolerable toxicity. Dose limiting toxicity (DLT) was evaluated in the first 28 days. Safety was evaluated per CTCAE 5.0, tumor assessments performed by Lugano 2014 every 8 weeks.

Results

As of Mar 27, 2024, 11 pts (9 follicular lymphoma [FL], 2 marginal zone lymphoma [MZL]) were enrolled. The median age was 48 years old, the median prior line of therapy was 1. All pts had previous anti-CD20 therapy. The most frequent treatment related adverse events (TRAEs) were lymphocyte decreased (63.6%), ANC decreased (63.6%) and WBC decreased (63.6%). Grade ≥3 TRAEs occurred in 10 pts, including lymphocyte decreased (63.6%), ANC decreased (27.3%), PLT decreased (18.2%), WBC decreased (9.1%) and pneumonia (9.1%). One patient experienced serious TRAE (PLT decreased). No AE led to drug discontinuation or death. Two DLTs (grade 4 PLT decreased without bleeding) were observed at 2.0 mg/kg IMM0306 + 20 mg Lenalidomide dose level. Among 11 pts, 3 pts achieved CR, 6 pts achieved PR and 1 patient had SD. The CRR, ORR and DCR were 27.3%, 81.8% and 90.0%, respectively. 1.6 mg/kg Amulirafusp alfa + 20 mg Lenalidomide was identified as RP2D by SRC.

Conclusions

1.6 mg/kg Amulirafusp alfa + 20 mg Lenalidomide was well-tolerated and with a robust preliminary anti-tumor activity in pts with R/R FL and MZL. This study is ongoing.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Funding

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Disclosure

W. Meng, Z. Wang, Q. Lu, W. Tian: Financial Interests, Personal, Full or part-time Employment: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. All other authors have declared no conflicts of interest.