Affimed N.V., a clinical-stage immuno-oncology company, has secured Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its investigational drug combination AFM24 plus atezolizumab. This designation pertains to the treatment of patients with advanced non-small cell lung cancer (NSCLC) that do not harbor activating epidermal growth factor receptor (EGFR) mutations and have progressed on prior platinum-based chemotherapy and PD-1/PD-L1 targeted therapy.
Fast Track Designation is a program implemented by the FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions. This designation is granted to therapies that promise to address unmet medical needs or offer significant improvement over existing treatment options.
The FDA’s decision to grant Fast Track Designation for AFM24 plus atezolizumab is based on promising initial efficacy data observed in the ongoing Phase 1/2a clinical trial designated AFM24-102 (NCT05109442). This trial evaluates the safety and efficacy of AFM24, an innate cell engager (ICE) molecule, combined with atezolizumab, a checkpoint inhibitor, for treating various NSCLC subtypes.
Early data from the EGFR wild-type NSCLC cohort of the AFM24-102 trial demonstrated encouraging responses in a subset of patients. Notably, this group included one patient who achieved a confirmed complete response, two with confirmed partial responses, and one with an unconfirmed partial response. These initial findings suggest that AFM24 plus atezolizumab has the potential to be an effective treatment option for patients with this specific form of advanced NSCLC who have exhausted other treatment avenues.
The Fast Track Designation allows Affimed to benefit from frequent interactions and meetings with the FDA throughout development. If clinical trials continue to yield positive results, this can potentially expedite regulatory hurdles and facilitate a quicker path to market approval for AFM24 plus atezolizumab.
The unmet medical need for effective therapies in EGFR wild-type NSCLC with progression on prior treatment is significant. This designation underscores the FDA’s recognition of the potential value proposition of AFM24 plus atezolizumab and its urgency in addressing this unmet need.
Affimed’s ongoing clinical development program for AFM24 plus atezolizumab holds promise for a new treatment option for patients battling this aggressive form of lung cancer. As the clinical trials progress, this combination therapy’s efficacy and safety profile will be further elucidated.
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