Abenacianine Injection Receives FDA Fast Track Designation, Helps Visualize Tumors During Surgery

The FDA granted a fast track designation for injectable abenacianine (VGT-309; Vergent Bioscience) as an adjunct for the intraoperative visualization of primary lung cancer, other pulmonary lesions, cancer-containing lymph nodes, and positive surgical margins in patients who are undergoing surgery for known or suspected cancer in the lung.¹ The designation follows results from a phase 2 trial (NCT05400226)² that showed abenacianine was safe and well-tolerated in the evaluated patient population.¹

According to experts, both minimally invasive surgery and robotic-assisted surgery methods are becoming utilized more in lung cancer resection because they are associated with shorter hospital stays, smaller incisions, less blood loss, and a decrease in complications post-operation (eg, chronic pleural pain); however, these approaches can limit surgeons’ ability to distinguish tumors from normal tissue.¹

Image credit: alfa27 | stock.adobe.com

Abenacianine is a novel, investigational, injectable tumor-targeted fluorescent imaging agent that can identify cancer in patients who are undergoing lung cancer surgery. Data from an open-label, single-arm, single-center phase 2 study (NCT05400226)² have shown that abenacianine has the potential to build confidence in these procedures by ensuring surgeons that all tumor tissue is removed.^1,3

For this trial, patients underwent surgical resection as planned 12 to 36 hours after receiving abenacianine. A total of 40 patients received a single 0.32-mg/kg dose, and following surgery, patients were observed for up to 2 hours to assess any possible treatment-emergent adverse events (AEs).^2,3

After being discharged from the hospital and about 14 days post-surgery, patients were contacted via telephone to surgery their well-being. Between days 19 and 39 post-surgery, patients either returned to their health center or attended a telehealth visit for final safety assessments. The end point of this study was the frequency that intraoperative molecular imaging with abenacianine resulted in a clinically significant event (CSE), such as localization of pulmonary nodules, discovery of unsuspected additional cancers, or identification of positive margins.^2,3

According to the findings, 17 (42.5%) of the total 40 patients who underwent pulmonary resection with abenacianine had at least 1 CSE. The investigators also observed that near-infrared imaging identified lesions that were not found by standard surgical methods in 16 patients, additional cancers were found in 1 patient, and margins within 5 mm of the closest staple line in 2 patients. Abenacianine was observed to be safe, well-tolerated, and without any drug-related serious AEs and infusion reactions in patients with a broad range of tumor types.^2,3

Further, enrollment for an open-label, multicenter phase 2 clinical trial, VISUALIZE (NCT06145048)⁴, which evaluated the efficacy and safety of abenacianine in patients undergoing surgery for proven or suspected cancer in the lung, was recently completed. For this study, patients will receive the same dose of abenacianine (0.32 mg/kg) administered for 15 to 20 minutes. Following surgery, subjects will be monitored for safety during their hospitalization, and between 7 to 14 and 25 to 35 days post-surgery, the patients will return to the health system or attend a telehealth visit for final safety assessments. At the last visit, if there are no AEs requiring further follow-up, patients will then be released from the study. Enrollment for the phase 3 confirmatory, multicenter VISUALIZE-2 study will commence in 2025.^1,4

“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 CEO at Vergent Bioscience, said 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.”¹

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. Businesswire. News release. January 7, 2025. Accessed January 7, 2025. https://www.businesswire.com/news/home/20250107433815/en/Vergent-Bioscience-Receives-FDA-Fast-Track-Designation-for-Abenacianine-for-Injection-VGT-309-to-Help-Surgeons-Visualize-Tumors-in-the-Lung-During-Surgery

2. Phase 2 Study of VGT-309 in Lung Cancer. ClinicalTrials.gov identifier: NCT05400226. Updated October 17, 2024. Accessed January 7, 2025. https://clinicaltrials.gov/study/NCT05400226

3. Bou-Samra P, Kennedy GT, Chang A, et al. Phase 2 Clinical Trial of VGT-309 for Intraoperative Molecular Imaging During Pulmonary Resection. Ann Thorac Surg. Published online May 31, 2024. doi:10.1016/j.athoracsur.2024.05.019

4. Phase 2B Safety and Efficacy Study of VGT-309 in Subjects With Cancer in the Lung. (VISUALIZE). ClinicalTrials.gov identifier: NCT06145048. Updated November 14, 2024. Accessed January 7, 2025. https://clinicaltrials.gov/study/NCT06145048