Clinical Update: AFM24-102 Trial in EGFR-Wildtype NSCLC

Affimed N.V., a biotech firm at the forefront of immuno-oncology, has reported encouraging clinical response data from its ongoing AFM24-102 phase 1/2a trial. This study focuses on patients with EGFR-wildtype non-small cell lung cancer (NSCLC) who have been heavily pre-treated and have shown resistance to PD-[L]1 targeted therapies. As of January 4, 2024, the data revealed that out of 15 patients, there was one complete response (CR) and two partial responses (PR) that have been confirmed, with an additional PR still pending confirmation through a follow-up scan.

The initial data presented in December 2023 indicated one confirmed PR and three responses that were yet to be confirmed. The patients in this cohort had a median of two prior treatments and had all progressed after PD-[L]1 targeted therapy. The positive responses have prompted Affimed to increase the number of EGFRwt NSCLC patients in the study to a total of 40. Moreover, the enrollment for the EGFR-mutant NSCLC cohort is also ongoing, with data from both cohorts anticipated in the first half of 2024.

Dr. Andreas Harstrick, the Chief Medical Officer and interim CEO of Affimed, expressed optimism about the responses, noting the significant need for new treatment options for patients who have exhausted all previous therapies, including PD-1/PD-L1 treatments. Affimed's proprietary ROCK® platform is at the heart of its approach, aiming to harness the innate immune system's potential to target and destroy a variety of tumors. The platform allows for the creation of customized innate cell engager (ICE®) molecules that leverage the body's immune cells to eliminate cancer cells.

AFM24, the subject of the study, is a unique tetravalent bispecific ICE® that activates the innate immune system by binding to CD16A on immune cells and EGFR on solid tumors, facilitating the destruction of cancer cells through antibody-dependent mechanisms. The company is also exploring the potential of combining AFM24 with an allogeneic off-the-shelf NK cell product, which could be particularly beneficial for heavily pre-treated patient populations.

Affimed is a clinical-stage company with a bold vision to empower patients' natural cancer-fighting capabilities. Headquartered in Mannheim, Germany, the company is driven by an experienced team with a shared goal of advancing cancer treatments.

The AFM24-102 study is an open-label, non-randomized, multicenter trial that is evaluating the combination of AFM24 with atezolizumab in patients with EGFR-expressing advanced solid malignancies who have not responded to prior treatments. The trial is registered under the identifier NCT05109442.