• Efficacy and safety of AFM24 in combination with atezolizumab, a checkpoint inhibitor, is being evaluated in non-small cell lung cancer patients with EGFR wild-type and EGFR mutant advanced/metastatic cancers in the ongoing AFM24-102 phase 1/2a study
• The FDA’s Fast Track designation was granted after its review of the initial efficacy data of the EGFR wild-type cohort from the AFM24-102 study
• Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need
• Company to host a conference call / webcast on June 1, 2024 at 7:00 p.m. EDT to discuss the updated data from the AFM24-102 trial

Affimed N.V. , a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that the FDA has granted Fast Track designation to the combination of its innate cell engager (ICE^®) AFM24 with atezolizumab for the treatment of patients with advanced and/or metastatic non-small cell lung cancer (NSCLC) not harboring any activating EGFR mutations (EGFR wild-type) after progression on PD-(L)1 targeted therapy and platinum-based chemotherapy. Data from the AFM24-102 study in this patient population will be presented at the upcoming annual meeting of the American Society of Clinical Oncology on June 1, 2024.

“The clinical data of AFM24 in combination with the checkpoint inhibitor atezolizumab is compelling. We're observing meaningful responses in patients resistant to prior checkpoint inhibitor treatment,” said Dr. Wolfgang Fischer, Chief Operating Officer at Affimed. “The Fast Track designation emphasizes the belief in the potential of this combination therapy to address currently unmet needs of patients with this devastating, life threatening disease who have exhausted all standard of care options, including chemotherapy and checkpoint inhibitors.”

Fast Track is a process designed to facilitate the development and expedite the review of new drugs that are intended to treat or prevent serious conditions and have the potential to address an unmet medical need. The FDA’s decision is based on initial activity observed in the first evaluable patients of the phase 2 part of the AFM24-102 study of AFM24 in combination with atezolizumab in heavily pretreated patients with NSCLC EGFRwt. With the Fast Track designation, the therapeutic development of the combination can benefit from more frequent engagement with the FDA, which will support the collection of appropriate data needed to accelerate its development.