Preliminary results from the phase 2 study of AFM24 in combination with atezolizumab in patients with EGFR wild-type (EGFR-WT) non-small cell lung cancer (NSCLC)

Abstract

Background: Immunotherapy combinations could be a promising strategy to overcome resistance to existing therapies. AFM24, a first in class, bispecific, tetravalent innate cell engager, binds CD16A on innate effector cells (NK cells and macrophages) and EGFR on solid tumors, redirecting and enhancing the innate and possibly the adaptive immune response towards tumors. Atezolizumab, a PD-L1 inhibitor, abrogates activation of the PD-1 immune checkpoint, potentiating the adaptive immune response. This Phase 1/2a study (NCT05109442) is evaluating if combining AFM24 with atezolizumab synergistically enhances both innate and adaptive immunity to effectively target EGFR+ solid tumors. Here we report initial results of the EGFR-WT NSCLC expansion cohort. Methods: The recommended Phase 2 dose of 480 mg AFM24 is given intravenously (IV) weekly in combination with 840 mg atezolizumab IV fortnightly, in patients with advanced or metastatic EGFR-WT NSCLC who progressed on 50% in target lesions from baseline. All responders were resistant to prior CPI. Seven patients achieved stable disease as BOR. After a median follow-up time of 5.5 (95% CI 3.45; 5.55) months, 8 patients are still on treatment including all responders. Conclusions: AFM24 with atezolizumab shows remarkable signs of clinical efficacy, even in patients with resistance to prior CPI, and a well-tolerated and manageable safety profile in patients with EGFR-WT NSCLC. The study is ongoing and up to 40 patients will be enrolled into this cohort. Clinical trial information: NCT05109442. Research Sponsor: Affimed GmbH. © (2024), (Lippincott Williams and Wilkins). All rights reserved.