Regeneron Pharmaceuticals and BioNTech SE have announced an update on their ongoing Phase 2 clinical trial evaluating a novel combination therapy for advanced non-small cell lung cancer (NSCLC). The study, which began recruiting participants on April 21, 2023, is testing the investigational cancer vaccine BNT116 in combination with cemiplimab, an anti-PD-1 antibody, compared to cemiplimab monotherapy in first-line treatment of patients with advanced NSCLC whose tumors express PD-L1 ≥50%.
Trial Design and Interventions
The Phase 2 study employs a randomized, parallel assignment model with no masking, focusing on treatment as its primary purpose. The trial is testing two key interventions: BNT116, administered via IV injection, and cemiplimab, administered via IV infusion every three weeks. The primary objective is to determine the safety, tolerability, and effectiveness of the combination therapy compared to cemiplimab alone.
BNT116, also known as FixVac Lung, represents an investigational cancer vaccine approach being developed by BioNTech. The study specifically targets patients with advanced NSCLC whose tumors express PD-L1 at levels of 50% or higher, representing a subset of patients who may benefit from immunotherapy approaches.
Study Timeline and Progress
The interventional study began on April 21, 2023, and is currently in the recruitment phase. According to the latest update submitted on July 10, 2025, the trial is expected to continue until this date, providing a timeline for tracking the study's progress and potential impact on future treatment options. The ongoing recruitment phase indicates that the companies are actively enrolling participants to meet their target enrollment numbers.
Market Implications
The study's outcome could significantly influence the stock performance of both Regeneron Pharmaceuticals and BioNTech SE. Positive results may boost investor confidence and position these companies favorably against competitors in the oncology market. The combination approach represents a strategic effort to enhance the efficacy of existing immunotherapy treatments by adding a cancer vaccine component.
The trial is listed on the ClinicalTrials portal, where further details about the study protocol, inclusion criteria, and endpoints are available. As the study progresses, any updates or preliminary results will be crucial for investors and the broader oncology community to monitor, given the potential implications for advanced NSCLC treatment paradigms.
