Affimed Updates on AFM24 and Atezolizumab in NSCLC Patients

Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology firm, has revealed promising new data from its AFM24-102 trial targeting non-small cell lung cancer (NSCLC). This study involves patients with both EGFR wild-type (EGFRwt) and EGFR mutant (EGFRmut) statuses who have shown resistance to previous therapies.

The recent data update, which includes information until May 13, 2024, focuses on 17 EGFRwt NSCLC patients. Among the 15 patients who were evaluable for response, there were four confirmed objective responses, comprising one complete response (CR) and three partial responses (PR). Additionally, eight patients achieved stable disease (SD), resulting in a 71% disease control rate. The median progression-free survival (PFS) was reported to be 5.9 months with a median follow-up duration of 7.4 months. Notably, three of the four responses had lasted for more than seven months. These results suggest that combining AFM24 with atezolizumab might offer a new alternative for overcoming resistance to established treatments.

Further, by May 21, 2024, the study had enrolled 21 heavily pretreated EGFRmut NSCLC patients, with 13 evaluable for response. This group also showed promising results, with one CR, three PRs, and six SD outcomes. At the time of the data cutoff, all responses were ongoing. EGFRmut NSCLC typically shows a weak response to single-agent immune checkpoint inhibitors, but the combination therapy of AFM24 and atezolizumab appears to be acting synergistically to improve efficacy.

In both EGFRwt and EGFRmut cohorts, the combination therapy of AFM24 and atezolizumab showed a manageable safety profile. Side effects were in line with known profiles of these drugs, predominantly involving mild to moderate infusion-related reactions and temporary increases in liver enzymes.

Dr. Andreas Harstrick, Affimed’s Chief Medical and acting Chief Executive Officer, expressed optimism about these findings. He highlighted the durability of responses in EGFRwt tumors, noting that such responses are unlikely to be driven by PD-1/PD-L1 blockade alone. Dr. Harstrick believes that the combination of AFM24 and atezolizumab addresses significant unmet medical needs in refractory NSCLC patients.

The trial is ongoing, with plans to enroll up to 40 patients in the EGFRwt cohort and up to 25 in the EGFRmut cohort. Further updates are expected in the second half of 2024.

AFM24 is a tetravalent, bispecific immune cell engager (ICE®) that activates the innate immune system by binding to CD16A on innate immune cells and epidermal growth factor receptors (EGFR) on tumors. This mechanism aims to kill cancer cells through processes like antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.

Affimed is dedicated to leveraging the innate immune system to combat cancer, with a range of ICE® molecules under clinical development. These molecules are generated using Affimed’s proprietary ROCK® platform, designed to create customized solutions for both hematologic and solid tumors.

The company is headquartered in Mannheim, Germany, and is led by a seasoned team of biotechnology and pharmaceutical experts. They are united in their mission to stop cancer from impacting patients' lives. Further details about Affimed’s projects and partnerships are anticipated in upcoming communications.