FDA Fast Tracks Abenacianine for Lung Cancer Surgery

• The FDA has granted fast track designation to abenacianine for injection (VGT-309) for use as an adjunct during surgery.
• Abenacianine is an investigational tumor-targeted fluorescent imaging agent.
• Findings from a phase 2 efficacy study (NCT05400226) support this fast track designation.

The FDA has granted fast track designation to abenacianine for injection, an investigational tumor-targeted fluorescent imaging agent, for use as an adjunct during surgery. The agent aims to enhance intraoperative visualization of primary lung cancer, other pulmonary lesions, cancerous lymph nodes, and positive surgical margins in patients undergoing surgical procedures for known or suspected lung cancer.¹

Findings from a phase 2 efficacy study (NCT05400226), published in The Annals of Thoracic Surgery, showed that abenacianine effectively visualized primary and metastatic tumor tissue in the lung during surgery. The imaging agent was found to be safe and well-tolerated by those enrolled in the trial.

The primary efficacy end point was the proportion of patients experiencing at least 1 clinically significant event (CSE), defined as the ability to locate difficult-to-find tumors, identify positive surgical margins, or detect previously undetected tumors that might have been missed with standard visual and palpation methods. Among 40 patients given abenacianine and undergoing standard-of-care surgical resection for suspected lung cancer, 43% (n = 17) experienced at least 1 CSE.

Lungs: © Mopic - stock.adobe.com

“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,” said John Santini, PhD, president and chief executive officer at Vergent Bioscience, in a press release. “We look forward to collaborating with the FDA to make abenacianine available to surgeons and their patients as quickly as possible.”

In the phase 2, open-label, efficacy study, investigators sought to evaluate the safety and efficacy of abenacianine for injection to identify cancer in subjects undergoing lung cancer surgery.² Enrollment was open to patients between the ages of 18 and 85 years who have a lung nodule or mass that might be considered primary lung cancer or lung metastases, whether or not it is biopsy-proven.

To be eligible for enrollment, patients needed to be scheduled for standard-of-care surgical resection of a lung nodule or mass with diagnostic and/or curative intent. They were also required to meet all preoperative surgical and anesthesia acceptance criteria and demonstrate acceptable kidney and liver function. Additional eligibility criteria included having an ECOG performance status of 0, 1, or 2 and meeting all standard surgical and general anesthesia requirements. Patients were excluded if they had participated in a clinical trial within the past 30 days.

In addition to the primary end point of identifying the proportion of patients with at least 1 CSE, secondary end points included sensitivity, negative predictive value, and positive predictive value.

In addition to this study, the phase 2, multicenter VISUALIZE study (NCT06145048) assessing the efficacy and safety of abenacianine in patients undergoing surgery for proven or suspected cancer in the lung recently completed enrollment.¹ Further, enrollment in the phase 3 confirmatory, multicenter VISUALIZE-2 study is set to begin in 2025.

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 7, 2025. https://tinyurl.com/68mtm6ft

2. Phase 2 study of VGT-309 in lung cancer. ClinicalTrials.gov. Updated December 17, 2024. Accessed January 7, 2025. https://clinicaltrials.gov/study/NCT05400226