Affimed Presents AFM24 Monotherapy Data in Non-Small Cell Lung Cancer at the Annual Meeting of the American Society of Clinical Oncology and Provides Strategic Update on AFM24 Development Plan - Seite 2

The AFM24 EGFR mutant NSCLC cohort is part of the AFM24-101 open-label, non-randomized, multi-center, phase 1/2a study (NCT04259450) investigating the safety, tolerability, and preliminary efficacy of AFM24 monotherapy in patients with advanced or metastatic EGFR+ solid tumors. Other cohorts being investigated included colorectal cancer (CRC) and renal carcinoma (RCC).

At the planned interim analysis, 15 patients with EGFR mutant NSCLC and a median of 2 prior lines of therapy had been treated with a median of 11 doses of AFM24. As of the cut-off date, the data showed clinical activity and signals of anti-tumor activity in 7 out of 15 heavily pre-treated patients, including two confirmed partial responses and five patients with stable disease (SD) resulting in an objective response rate of 13% and a disease control rate of 47%. All patients with stable disease were progression free for at least 3.5 months, with one patient exhibiting ongoing SD for more than 8 months. A reduction in tumor burden was observed in five of 13 patients (38%) with available baseline and subsequent tumor assessments based on RECIST criteria. All patients showed a well-managed safety profile with the majority exhibiting mild-to-moderate treatment-related adverse events in-line with previous findings, highlighting the well-managed safety profile that makes AFM24 a candidate for combination approaches. One Grade 5 (pneumonitis) adverse event was reported in a patient with progressive disease and multiple comorbidities; however, since relation to AFM24 could not be ruled out it is deemed treatment related. Although the formal continuation criteria for the cohort were not met, these data provide proof of concept that targeting NK cells can induce remission in patients with especially hard-to-treat solid tumors.

“We believe that AFM24 can be an important addition to the treatment armamentarium for addressing EGFR mutant tumors as the early anti-tumor effects support further evaluation in a combination setting with the goal of achieving meaningful patient benefit. That is why we are adding an EGFR mutant NSCLC cohort to our ongoing phase 1/2 study in combination with Roche’s PD-L1 checkpoint inhibitor atezolizumab,” said Dr. Andreas Harstrick, Chief Medical Officer at Affimed. “Our broad AFM24 program aimed at identifying the right therapeutic settings and indications, and we believe that the data generated to date allow us to build the right path forward to maximize patient benefit.”