Abenacianine Wins FDA Fast Track Designation for Tumor Visualization in the Lung

Abenacianine (VGT-309), an investigational tumor-targeted fluorescent imaging agent, was granted fast track designation by the FDA to help intraoperative visualization of primary lung cancer, cancer containing lymph nodes, other pulmonary lesions, and positive surgical margins in patients receiving surgery for suspected or known cancer in the lung.1

“Receiving fast track designation from the FDA reinforces the potential of abenacianine to address existing deficits in lung cancer surgery by helping surgeons better visualize tumors in the lung during minimally invasive surgical procedures,” John Santini, PhD, president and chief executive officer at Vergent Bioscience, stated in a news release. “We look forward to collaborating with the FDA to make abenacianine available to surgeons and their patients as quickly as possible.”

The efficacy of abenacianine was evaluated in 2 phase 2 trials in patients undergoing surgery for suspected or confirmed cancer in the lung. Data from the first study (NCT05400226) demonstrated that abenacianine effectively visualized primary and metastatic tumor tissue in the lung and was shown to be safe and well-tolerated with no reported infusion reactions or drug-related serious adverse effects (AEs).1,2 Of note, 17 patients (42.5%) of 40 in the study who underwent pulmonary resection and received abenacianine experienced at least 1 clinically significant event.2

The primary end point of the phase 2 study was clinically significant events following intraoperative molecular imaging with the use of abenacianine. The study included 4 secondary end points, which included sensitivity to abenacianine, negative predictive value, specificity, and positive predictive value.3 Sensitivity is defined as the probability that the tissue fluoresces intraoperatively when it is cancer as histologically confirmed; negative predictive value is defined as the probability that tissue samples do not contain cancer on the histologic exam if it does not fluoresce intraoperatively; specificity is defined as the probability that tissue does not fluoresce intraoperatively when there is no present cancer, determined by histology; and positive predictive value is defined as the probability that a tissue sample contains cancer on histologic exam if it fluoresces intraoperatively.

Abenacianine is also being evaluated for efficacy and safety in the phase 2b, multicenter, open-label VISUALIZE study (NCT06145048) in approximately 100 patients with suspected or confirmed cancer in the lung.4 Patients in the study received 0.32 mg/kg of VGT-309 administered intravenously 12 to 36 hours before surgery. Following the administration of abenacianine, patients were observed for 1 hour and were asked about any treatment-emergent AEs.

The primary end point of the study is the proportion of patients who demonstrated at least 1 clinically significant event based on measurements taken under standard of care surgery and near-infrared imaging. The secondary end point is the sensitivity to abenacianine, the positive predictive value (PPV), and 1-PPV of VGT-309 with near-infrared imaging for lesions in vivo.

References

1. Vergent Bioscience receives FDA fast track designation for abenacianine for injection (VGT-309) to help surgeons visualize tumors in the lung during surgery. News release. Vergent Bioscience. January 7, 2025. Accessed January 9, 2025. https://www.vergentbio.com/press-releases/vergent-bioscience-receives-fda-fast-track-designation-for-abenacianine-for-injection--(vgt-309)-to-help-surgeons-visualize-tumors-in-the-lung-during-surgery-
2. Bou-Samra P, Kennedy GT, Chang A, et al. Phase 2 clinical trial of VGT-309 for intraoperative molecular imaging during pulmonary resection. Annals Thorac Surg. 2024:S0003-4975(24)00396-5. doi:10.1016/j.athoracsur.2024.05.019
3. Phase 2 study of VGT-309 in lung cancer. ClinicalTrials.gov. Updated October 17. 2024. Accessed January 9, 2025. https://clinicaltrials.gov/study/NCT05400226
4. Phase 2B safety and efficacy study of VGT-309 in subjects with cancer in the lung (VISUALIZE). ClinicalTrials.gov. Updated November 14, 2024. Accessed January 9, 2025. https://clinicaltrials.gov/study/NCT06145048