Affimed N.V. reports promising results from AFM24-102 trial in NSCLC

Affimed N.V. (Nasdaq: AFMD), a pioneering immuno-oncology company, has released compelling clinical data from its ongoing AFM24-102 study, showcasing significant advances in treating non-small cell lung cancer (NSCLC). This data, involving both EGFR wild-type (EGFRwt) and mutated (EGFRmut) NSCLC cohorts, marks a pivotal step in leveraging the innate immune system to combat cancer effectively.

Clinical Trial Updates and Efficacy

As of the latest data cut-off on May 13, 2024, the EGFRwt cohort reported four objective responses among 15 evaluable patients, including one complete response and three partial responses, alongside eight instances of stable disease, culminating in a disease control rate of 71%. These patients, previously resistant to checkpoint inhibitor treatments, highlight the potential of combining AFM24 with atezolizumab, an anti-PD-L1 therapy, to overcome resistance. The median progression-free survival was reported at 5.9 months from a median follow-up of 7.4 months, with three out of four responses enduring beyond seven months.

For the EGFRmut cohort, updated as of May 21, 2024, initial results from 13 response-evaluable patients also demonstrated encouraging outcomes. The combination therapy led to one complete response, three partial responses, and six instances of stable disease among heavily pretreated patients (median of three prior therapies). Remarkably, all responses are ongoing, signaling the potential synergistic effects of AFM24 and atezolizumab in enhancing clinical efficacy in a subtype typically characterized by poor response to single-agent immune checkpoint inhibitors.

Safety Profile and Treatment Impact

The combination of AFM24 and atezolizumab has maintained a manageable safety profile, with side effects aligning with the known properties of the individual treatments. The most common side effects were mild to moderate infusion-related reactions and transient liver enzyme elevations.

Dr. Andreas Harstrick, Chief Medical and acting CEO of Affimed, commented on the results: “The efficacy of the combination of AFM24 and atezolizumab in these heavily pretreated NSCLC patients is encouraging and supports our hypothesis of a synergistic activity of AFM24 with PD-1/PD-L1 blockade. The remarkable durability of the responses in EGFRwt tumors is a testament to the innovative approach of our treatment, transcending traditional PD-1/PD-L1 blockade mechanisms.”

Ongoing Research and Future Outlook

The AFM24-102 study is set to enroll up to 40 patients in the EGFRwt cohort and 25 in the EGFRmut cohort, with ongoing recruitment expected to provide further updates in the second half of 2024. AFM24, a tetravalent bispecific ICE (innate cell engager), uniquely targets CD16A on innate immune cells and EGFR on tumor cells, promoting cancer cell elimination through dual mechanisms of action. This innovative approach, developed through Affimed’s ROCK platform, underscores the company’s commitment to addressing unmet medical needs in refractory NSCLC patients.