Vergent Bioscience's abenacianine (VGT-309) has received Fast Track designation from the FDA as an adjunct for intraoperative visualization of lung cancer. This investigational tumor-targeted fluorescent imaging agent aims to improve the detection of primary lung cancer, pulmonary lesions, cancer-containing lymph nodes, and positive surgical margins during surgery for known or suspected lung cancer.
The FDA's decision was influenced by positive safety, tolerance, and enhanced tumor visualization results observed in lung cancer patients during Phase 2 trials. John Santini, PhD, President and CEO of Vergent Bioscience, stated that the designation reinforces abenacianine's potential to address existing deficits in lung cancer surgery, especially during minimally invasive procedures.
Clinical Efficacy
Data from a Phase 2 efficacy study (NCT05400226) published in The Annals of Thoracic Surgery demonstrated clinically significant outcomes in 42.5% of trial participants. The study evaluated the safety and efficacy of VGT-309 in identifying cancer in patients undergoing lung cancer surgery. Clinically significant events included the localization of lesions not found by standard surgical techniques, identification of synchronous and occult cancers, and identification of inadequate surgical margins.
Specifically, near-infrared imaging with VGT-309 identified lesions missed by standard surgical methods in 16 patients, detected additional cancers missed in preoperative imaging in one patient, and identified margins within 5 mm of the closest staple line in two patients. The agent was also found to be safe and well-tolerated across a range of tumor types, including adenocarcinoma, lymphoma, and sarcoma.
The Need for Improved Visualization
Lung cancer is a leading cause of cancer deaths in the United States, with an estimated 234,580 new cases diagnosed and 125,070 deaths in the past year. While minimally invasive surgery (MIS) and robotic-assisted surgery offer benefits like shorter hospital stays and reduced post-operative complications, they can limit a surgeon's ability to distinguish tumors from normal tissue.
Abenacianine aims to address this challenge by providing real-time visualization of tumors, potentially improving the precision and completeness of surgical resections. According to Vergent Bioscience, data from clinical studies suggest that abenacianine may help overcome existing challenges to tumor visualization and thereby optimize surgical outcomes for physicians and patients.
Ongoing and Future Studies
Vergent Bioscience has completed enrollment for the Phase 2 VISUALIZE study (NCT06145048), which further evaluates the efficacy and safety of VGT-309 in patients undergoing surgery for proven or suspected lung cancer. The company intends to begin enrollment in the Phase 3 confirmatory, multicenter VISUALIZE-2 study in 2025.
The FDA's Fast Track designation will allow for more frequent communication and a rolling submission of the marketing application, potentially expediting the availability of abenacianine to surgeons and patients.
